DEVICE MASTER RECORD INDEX

Document Type Document Page

Index Device Master Record Index 1
I. Device Master Device Master 2,3
II. Brief Description of Operation A. Component Preparation 3,4
B. Production Room 4,5
C. Sterilization 5
D. Packaging 5
III. Production Flow Charts Flow Chart 6
IV. Device Specifications A. Component Specifications 7
B. Labeling Specifications 7
C. Packaging Specifications 7
D. Intermediate Specifications 7
E. Finished Product Specifications 7
F. Product Engineering Drawings 8
V. Production Process Specifications A. Equipment Specifications 8
B. Production Methods 8
C. Production Procedures, 8
D. Environmental Specifications 9
VI. Sterilization Specifications A. Method 9
B. Validation 9
C. Verification 9
VII. Inspection A. Procedures 10
B. Specifications 11
C. Acceptance Criteria 11, 12
VIII. Design Verification Records Design Verification 12
IX. Process Validation Records Process Validation 12
X. Revision History Revision History 12
 I. DEVICE MASTER

A. Description
NutraMax Polyethylene Plastic Adhesive Bandage is a medical device consisting of a sterile adhesive coated,
ventilated Polyethylene film with a highly absorbent pad (compress). The adhesive coating is protected by a
release paper. A Regular Wrapper is a standard tab opening adhesive bandage package sealed by pressing two
cohesive coated papers together under pressure.

B. Intended Medical Use

Used in first aid applications to dress wounds. Protects wound. Helps promote healing, Use on minor cuts,
scrapes, burns.

C. Operating Instructions / Instructions for Use

Apply bandage to clean, dry skin.

D. Warnings / Precautions
“Sterility guaranteed untless wrapper is opened or damaged”

E. Regulatory Classification
Class I Sterile Medical Device. Product is exempt from the pre-market notification requirement (510(k)) under
the Food, Drug, and Cosmetic Act 21 CFR, Section 513(d)(2)(A).

F. Classification Number / Name

880.5240 Medical adhesive tape and adhesive bandage

G. Latex & Dry Natural Rubber Status of Product and Packaging

The medical device and its primary packaging are latex free and contain no dry natural rubber. Note: Black tape
used for splicing component rolls in manufacturing adhesive bandage products, although not intended to be part of
the finished device, is also latex free and contains no dry natural rubber

8. Product Shapes
Product is made into a variety of shapes determined by the cutting die and type of machine. An approved
drawing of each is established and maintained by NutraMax Quality Assurance Document Control in a file
called “Approved Product Specification Drawings”. The sizes and particular features of each are found in the
NutraMax First Aid Products “Finished Product Specifications Manual”, maintained by the Quality Assurance
Department.
I. Components
The common components are as follows:

Adhesive Tape, Polyethylene backing with acrylic based adhesive

Pad Material
Release Paper
Top Paper
Bottom Paper

Specific requirements are found in the NutraMax First Aid Products Component Specifications file, maintained
by the Quality Assurance Department. The Bills of Materials are in the “Item Current Routing” file maintained
by the Quality Assurance Department.

J. Sterilization
This medical device shall be sterilized to achieve a Sterilization Assurance Level of 10 -6. Sterilization is via
Ethylene oxide gas (meets State of California Proposition 65 Ethylene oxide residuals requirements).

K. Packaging
The primary packaging material is a latex free cohesive paper that is designed for terminally sterilized medical
devices. The packaging material is porous and provides an adequate microbial barrier to microorganisms in
order to provide sterile package integrity and product safety. The package seal closure presents a microbial
barrier to at least the same extent as the rest of the packaging.

12. Labeling
Labeling meets the requirements for medical devices established in the Food, Drug, and Cosmetic Act, 21 U.S.C.
Title 21 and in 21CFR Part 801.

13. Quality System

The Quality System meets the requirements regulated under 21CFR Section 820.

II. BRIEF DESCRIPTION OF OPERATION

A. Component Preparation

1. Adhesive Tape for Finger Bandages

Adhesive Tape rolls are received from the NutraMax Adhesive Coatings Division or from a printing vendor (for
printed tapes). The adhesive side is protected with a release paper. The tape from the NutraMax Adhesive
Coatings Division is either pre- perforated (for ventilation of the adhesive bandage end product) or is received
and then perforated at the NutraMax First Aid Division - Houston facility. The perforation is performed
using a patented system which uses ultrasonic waves directed by a “horn” which vibrates and heats up a roller
with metal pins. The heating of the metal pins melts the Polyethylene backing which passes over the pin rollers
and produces a perforated “hole”.

2. Release Paper
Release paper which is part of the adhesive tape rolls is separated from the tape rolls, slit and placed over the
tape with pad in a continuous motion on the bandage conversion machines.

3. Pad Material
Pad material is received in rolls from the vendor. The pad material is either pre-slit to size by the vendor or sent
in master roll form where it is slit to size at the NutraMax Houston facility.
4. Printed (Top) Wrapper Paper
Latex free cohesive paper is received in rolls from the vendor. The paper is printed at the NutraMax Houston
facility. During the printing operation, the paper is also slit to size for the product. As an option, the paper
may be ordered pre-printed and pre-slit from the vendor.

5. Blank (Bottom) Wrapper Paper

Latex free cohesive paper is received in rolls from the vendor. The paper is slit to size for the product. As an
option, paper may be ordered pre-slit from the vendor. Some customers may require the bottom wrapper
paper to be printed. See individual Bills of Materials for applicable products.

II. BRIEF DESCRIPTION OF OPERATION

B. Production Room

General Description of the Process

Component and packaging material are purchased from approved vendors using a purchase order system. Vendors
are audited on a periodic basis. Each vendor’s lot received on different shipments or purchase orders are logged in
and given a unique NutraMax lot number. Components and packaging are not received without a NutraMax
purchase order. The components and packaging are physically placed in a receiving quarantine area. The lots are
identified with a case identification label and each pallet identified with a pallet identification label. The pallet
identification label contains a section of the label that say “Quarantine”, “Not Sterile”. Each lot is inspected and/or
testing using pre-approved and statistically valid methods, including some items that must include a certificate (of
analysis or of conformance) provided by the vendor. The inspection and testing is documented. The disposition of
the item is documented, including the date and signature of the person(s) conducting the inspection and testing. The
status of the material in the receiving quarantine area is determined by the pallet label. The initial label identifies the
product as being in quarantine. If the pallet is released, a green release label, signed and dated, is applied over the
“Quarantine Not Sterile” portion of the pallet identification label. If the pallet is rejected, a red “Reject” label, signed
and dated, is applied over that portion of the pallet identification label. Product is not removed from the quarantine
receiving area until a release or reject label is applied to the pallet identification label. Product that is released is
placed into numbered pallet storage locations. Product that is rejected is placed in a non-conforming product area,
“QCNCHOLD”. Product is stored and moved under conditions which protect the materials from contamination.

Production is made to maintain a safety stock or made to order. A job order is prepared and printed by the Planning
Department. The job order is a unique number that is generated by the inventory control / manufacturing computer
system. As the job order is scheduled to run (on an assigned machine), the job order document is given to the
Production Control Department. The Production Control Department prints a “Pick List” that is used to pick the
components and packaging for the job order. Each component or packaging item has a separate “Pick List”. The
Production Control Department goes to one of the locations printed on the pick list and obtains all the materials
necessary for the job. The materials are picked by the lot number and a “First In - First Out” sequence of lots is
picked. The materials are brought to a staging area. A copy of the job order and the picklist remain with the
materials. The date, quantity, and initials of the person picking the materials is documented on the picklist.

The components and packaging for the job order are moved from the staging area to the production machine on
which it is scheduled to run. A production employee co-signs the picklist to verify that the information is correct.
Each job is documented on the Cleaning and Use log found on the machine. The Machine Operator initials, dates,
and confirms on the log that the machine is clean prior to running the job order. An Operator Quality Inspection
form is completed by the operator. Each hour the Machine Operator checks and records information regarding the
quality of the production. Quality Control Line Inspectors audit the process. Each production case is identified with
an identification label which includes the item number, lot number, description, and quantity contained. The case
receives a chemical change sterilization indicator tape. Strip rolls receive a chemical change sterilization indicator
tape on the roll inside the cases as well. When a pallet of manufactured product is complete, the Production Control
Department prints and affixes a pallet license identification label on each pallet and records the date, lot number, and
initials on the original job order form. A “Send to Sterilization” sign is applied to at lease two (2) sides of the pallet.
Quality Control (QC) Line Inspectors audit the pallet using statistically valid sampling procedures. The results of the
audit are documented. If the pallet passes the QC audit, the pallet license is stamped “Inspected” or “Released”,
dated and initialed by the QC Line Inspector. The pallet is then moved to the sterilization staging area “TRUCKST”.
A manifest is printed out for all the pallets of product going to sterilization. The manifest identifies the item number,
lot number, description, and quantity of each pallet destined for one truck going to sterilization. The manifest has a
unique manifest number which is used as the NutraMax sterilization lot number.

II. BRIEF DESCRIPTION OF OPERATION

C. Sterilization

Product is sent to a NutraMax qualified contract sterilization company which uses a NutraMax validated Ethylene
oxide sterilization process. Products are validated using product families. The validation includes sublethal
processing and residual dissipation profiles for Ethylene oxide and reaction by-products (Ethylene chlorohydrin).

II. BRIEF DESCRIPTION OF OPERATION

D. Packaging

Packaging of the device may be performed by (1) sending strip rolls to sterilization and then running the strip rolls
on strip roll feeders, where the rolls are cut to the individual package size and hand packed into cartons, trays, or
bulk or (2) cutting the continuous strip directly on the bandage conversion machine, hand packing in consumer unit
cartons or bulk packing into shipping cases and then sterilizing the shipping cases. Strip roll feeders are equipped
with sensors that cut and count the strips and sensors that detect marked strips for defects found at the bandage
conversion machine. Inner packs of cartons may be banded, shrink wrapped, or placed in trays. Strips may be
packed into consumer unit cartons as singles (all one size) or assorted (more than one size) strips, Each lot of sterile
product packaged on the strip feeders is recorded on a Cleaning & Use Log kept at the machine. Packaging Machine
Operators check the components against a job order and read the working instructions noted on the job order. Each
finished pallet of product receives a license plate identification, which is stamped “Inspected” or “Released”,
initialed and dated by Quality Control Line Inspectors, if the product meets specifications.
 IV. DEVICE SPECIFICATIONS
A. Component Specifications

Component specifications are established and maintained in a file “Component Specifications”.

Official copies may be found in the QA Document Control office and the Incoming Receiving
Inspection office. Approved Master samples are established and maintained. These may be found
in the Incoming Receiving Inspection office. Components used to manufacture specific items are
found in the file “Item Current Routing” for the specific item which is maintained in the QA
Document Control office.

IV. DEVICE SPECIFICATIONS

B. Labeling Specifications

Labeling Specifications are established and maintained in a file “Master Label Record” found in
the Incoming Receiving Inspection office.

IV. DEVICE SPECIFICATIONS

C. Packaging Specifications

Packaging specifications are included in the “Component Specifications” file.

IV. DEVICE SPECIFICATIONS

D. Intermediate (WIP) Specifications

Intermediate (Work-In-Process or WIP) Specifications are found as part of the “Approved

Product Specification Drawings”, the “Approved Item Current Routing” files, and the
“Approved Finished Product Specification” files, located in the QA Document Control office.
Additional master samples, pictures, and drawings may be used as visual aids.

IV. DEVICE SPECIFICATIONS

E. Finished Product Specifications

Finished Product Specifications are established and maintained in a file “Finished Product
Specifications”. The file may be found in the QA Document Control office. Adhesive Bandages,
Polyethylene Plastic with Regular Wrapper may be found under “STRIPPLREG”.

IV. DEVICE SPECIFICATIONS

F. Product Engineering Drawings

Product Engineering Drawings are established and maintained in a file “Approved Product
Specification Drawings”. The file may be found in the QA Document Control office.
 V. PRODUCTION PROCESS SPECIFICATIONS
A. Equipment Specifications

Equipment specifications are established and maintained in a file “Equipment Validation Book”
for each piece of equipment used to make the medical devices. The Equipment Validation Books
are found in the Engineering Office Library. The machine(s) used to manufacture the bandages
may be found in the Approved Product Specification List (Form QA-101) in the NutraMax First
Aid Division SOP Forms manual. A controlled copy of that list is found in the front of the
“Approved Product Specification Drawings” file.

V. PRODUCTION PROCESS SPECIFICATIONS

B. Production Methods

Production methods are established and maintained in the file “Equipment Validation Book” for
each piece of equipment used to make the medical devices.

V. PRODUCTION PROCESS SPECIFICATIONS

C. Production Procedures

Production procedures are established and maintained in the file “Standard Operating
Procedures”. Sections pertinent to the production of Adhesive Bandages, Polyethylene Plastic
with Regular Wrapper include the following:

Sect. Title Procedure for

4 Perforation Department perforating tape
5 Strip Department manufacture bandage
8 Packaging Department package bandages
12 Slitting Department slit pad material and paper
30 Printing Department print paper

V. PRODUCTION PROCESS SPECIFICATIONS

D. Environmental Procedures

Raw material, equipment, production areas, and personnel practices will be maintained to
prevent contamination of the medical devices. Temperature and humidity in the production areas
will be maintained for the comfort of the employees. An environmental monitoring program is
established and maintained as per SOP 14.700. (Environmental air monitoring is performed
monthly using the settling plate method).

VI. STERILIZATION SPECIFICATIONS

A. Method
Adhesive Bandages, Polyethylene Plastic with Regular Wrapper is sterilized by an outside
contract sterilization company using Ethylene oxide.

VI. STERILIZATION SPECIFICATIONS

B. Validation

Process validation for Ethylene oxide sterilization is reviewed and revalidated on an annual
basis. Validation sterilization procedures are conducted as per SOP# 16.501 “Validation of
Ethylene Oxide Sterilization Process”.The process is validated to a Sterility Assurance Level
(SAL) of 10-6. The level of residual Ethylene oxide and reaction by -products present subsequent
to the manufacturing process are studied and reported. Sublethal processing and half-cycle
processing is used to establish processing parameters. The validation is performed using product
families with respresentative samples from each product group.

VI. STERILIZATION SPECIFICATIONS

C. Verification

Sterilization verification is performed using Biological Indicator / Syringe / Pouch Assemblies.

Each sterilization load received 22 indicators, placed in the positions determined by the Ethylene
oxide Sterilization Process Validation. Biological Indicatior Procedures are found in SOP#
11.106. Sterilization loads are placed in quarantine until the Biological Indicator sterility testing
results are received from the testing laboratory, indicating no growth in the 22 indicator units.

VII. INSPECTION PROCEDURES

A. Procedures

1. Incoming Components Inspection and Testing. For each shipment received, each
vendor’s lot of each component is quarantined upon receipt, sampled, inspected, and tested
according to the specifications established for the component. Sampling and inspection are
based on ANSI Z1.4. All results are documented.

2. In-Process Inspection & Testing. Inspections and testing are performed during production
by the machine operators and Quality Control Line Inspectors. At least once per hour, the
machine operator inspects the quality characteristics of the devices being manufactured and
document the results. Inspections and testing are performed on each pallet of work-In-
Process (WIP) product manufactured. No more than one job order is on each pallet presented
for inspection and testing by Quality Control. The inspection and testing are based on ANSI
Z1.4. A completed pallet is identified with a pallet license palate which must be stamped,
initialed, and dated by Quality Control before the pallet is moved to the warehouse. The
documented results are filed with each production job order (device history file).
3. Pre-Sterilization Inspection. WIP items are sent to an outside sterilization contractor
(Ethylene oxide). Each case of WIP product receives a strip of chemical change indicator
tape. The presence of this tape on each case is verified & documented by QC on the pallet
release inspection.

4. Post-Sterilization Inspection. Sterile WIP product is returned from the sterilization

contractor and placed in quarantine until the biological indicator challenge devices (22 per
sterile lot chamber) have been tested by an outside laboratory (5 day incubation period). QC
inspects the documentation. The sterile manifest is checked to verify the product lots and
quantities sent to the sterilizer have been returned and reconciled. The sterilization batch
router is reviewed, and the chemical change indicator tape is verified. QC applies green
“Release” labels with initials and dates to each pallet of sterile product released from
sterilization. The documentation is filed by sterilization manifest number.

5. Packaging Operation & Testing. After sterilization and release, product is packed in the
Production Packing Department. Inspections and testing are performed by Machine Packers
and Quality Control Line personnel. The Machine Packer inspects and tests the quality
characteristics being packed at least once per hour and records the results on the appropriate
form. A completed pallet receives a pallet license plate. QC inspects and tests the packed
product using ANSI Z1.4 as a system of sampling. The pallet license plate must be stamped,
initialed, and dated before packed finished product is release to the warehouse for storage
and distribution. QC results of the inspection and testing are recorded. The Machine Packer
documentation and the QC documentation are filed with the job order (device history record).

VII. INSPECTION PROCEDURES

B. Specifications

1. Incoming Components Inspection Specifications. Each component is inspected using a

“Component Release Testing” form (QA-25-XXX), which specifies the characteristics to
inspect/test, the sampling plan, and the acceptance rejection rate of each. This form is found
in the Incoming Receiving Area Office and the Quality Assurance Document Control office.
Additional reference information is found in the “Component Technical Specification” for
the component found in the Incoming Receiving Area Office and the Quality Assurance
Document Control Office. A “Master Material Sample Record” is maintained for all medical
device components and a “Master Label Record” is maintained for all labeling materials. The
“Master Material Sample Record” and “Master Label Record” is found in the Incoming
Receiving Area Office, with the exception of Master Label Records for shipping case labels
on products manufactured or assembled at the Houston location (WIP and Finished Products)
which are found in the QC Line Inspector files in the Production Strip Room.
2. In-Process Inspections Specifications. Work-In-Process (WIP) Specifications are found in
“Approved Product Specification Drawings”, “Approved Item Current Routing” files, and
the “Approved Finished Product Specification” files found in the QA Document Control
office. Additional specifications are found in Form QA-8-3 “Finished Product Release
Testing - Adhesive Bandage Rolls”, and Form QA-62-1 “Operator Inspection Record
Adhesive Bandage Rolls”.

3. Finished Product Inspections Specifications. Finished Product Inspections Specifications

are found in “Approved Product Specification Drawings”, “Approved Item Current Routing”
files, and the “Approved Finished Product Specification” files found in the QA Document
Control office. Additional specifications are found in Form QA-8-9 “Finished Product
Release Testing - Packaging Department.

VII. INSPECTION PROCEDURES

C. Acceptance Criteria

1. Incoming Components Acceptance Criteria. The acceptance criteria for components used
on these products is found in the individual QA-25 - XXX “Component Release Testing”
form used for incoming inspections. These forms are found in the Incoming Receiving Area
office and the QA Document Control office.

2. In-Process Inspections Acceptance Criteria. The Work-In-Process (WIP) inspections

acceptance criteria is found in QA-8-3 “Finished Product Release Testing - Adhesive
Bandage Rolls”. These forms are used for inspecting each pallet of each lot (work order) of
adhesive bandage rolls manufactured.

3. Finished Product Inspections Acceptance Criteria. Finished Product inspections

acceptance criteria is found in QA-8-9 “Finished Product Release Testing - Packaging
Department”. These forms are used for inspecting each pallet of each lot of adhesive bandage
finished products manufactured.

VIII. DESIGN VERIFICATION RECORDS

Adhesive Bandages, Polyethylene Plastic with Regular Wrapper are exempt from 21 CFR Part
820.30 “Design Controls”. For applicable products, the Design Verification Records are
maintained in the QA Document Control office, using SOP 21.205 “New/Changed Product
Design Validation” and Form RD-8 “Product Design Verification / Validation”.

IX. PROCESS VALIDATION RECORDS

Sterilization Process Validation Records. Sterilization Process Validation Records are

maintained in the QA Document Control office.
Bandage Conversion Process Validation Records. Bandage Conversion Process Validation
Records are maintained in the QA Document Control office.

X. REVISION HISTORY