Yr YTY Integra Tower, #19-01, Intermark, 348 Jin Tun Razak 50400 Kuala Lumpur, Malaysia SAFETY DATA SHEET SECTION 1 : IDENTIFICATION Product Name Non Sterile Powder Free White Nitrile Examination Gloves -N32WHT Intended use A patient examination glove is a disposable device intended for ‘madical purpose that is wom on the examiner's hand or finger to prevent contamination between patent and examiner Coating Donning Surface: Online Chlorination Outside Surface: Online Polymer Coated Manufacturer Name YTY Group Emergency phone no +03-21770000 Information phone no: +03-21770002 SECTION 2 : HAZARD (S) IDENTIFICATION Some ingredients used in the manufacture of gloves are hazardous but final product (glove) isnot hazardous. SECTION 3 : COMPOSITION/INFORMATION ON INGREDIENTS Materi ‘Chemical Name Partby | CASNo. weight Base Material ‘Carboxylate Butadiene Acrylonitrie Polymer |>95.0 | Moxture-N/A Latex [/pH Adjuster Potassium Hydroxide 010-200 | 7310-58-3 pH Adjuster ‘Ammonium Hydroxide 0.10-2.00 | 1336-216 Activator Zinc Oxide (050-200 _| 1314-13-12 Rubber Accelerator | Zinc Diethyl Dithiocarbamate(ZDEC) 0.10- 1.00 | 14324-55-1 Rubber Ascelerator | Zinc Dibuty! Dithiocarbamate (DBC) 0.10-1.00 | 136-23-2 Vuleanizing Agent | Sulphur 0.50 - 2.00 | 7704-34-9 White Pigment Titanium Dioxide <2.00 | 13463.67-7 Defoamer Defoamer Concentrate <030 [NASECTION 4 : FIRST-AID MEASURES Ian allergic reaction occurs, discontinue use immediately and consult with a physician. SECTION 5: FIRE-FIGHTING MEASURES Special Fire Fighting Procedure: + C02, Water, Foam and Dry Powder, Unusual Fire and Explosion Hazards : None known SECTION 6 ; ACCIDENTAL RELEASE MEASURES Emergency Procedure : Not Applicable Waste Disposal Method + Inaccordance with all local, state and federal regulations SECTION 7: HANDLING & STORAGE ‘Store in a cool, dry, and well-ventilated area. Gloves should be shielded from direct sunlight, fluorescent lighting and x-rays. SECTION 8 : EXPOSURE CONTROLS/PERSONAL PROTECTION Respiratory Protection + Notnecessary under normal conditions Ventilation : Normal room ventilation Protective Equipment 2 Notnecessary SECTION 9 : PHYSICAL & CHEMICAL PROPERTIES ‘Not Applicable SECTION 10 : STABILITY & REACTIVITY Stability > Stable Condition to Avoid Extreme Heat (Decompositon at 900°C) Hazardous Decomposition of Byproducts: Thermal decomposition at extreme temperature may produce compounds of cyanideSECTION 11 : TOXICOLOGICAL INFORMATION Inhalation Health Risks and Symptoms of Exposure None known Skin and Eye Contact ané Symptoms of Exposure None known Skin Absorption Health Risks and Symptoms of Exposure: Do notexpose this glove to any person known or suspected to be sensitive to Nile Latex or components used in making of these gloves as it may cause allergic reaction in some people. SECTION 12 : ECOLOGICAL INFORMATION Not Applicable SECTION 13: DISPOSAL CONSIDERATION Not Applicable SECTION 14 : TRANSPORT INFORMATION Not Applicable SECTION 15 : REGULATORY INFORMATION Not Applicable SECTION 16 : OTHER INFORMATION Date 1102/2016 Revision 0ENT OF HEALTH & HUMAN SERVICES aterm 10f 2 “noe W305 New Harpstire Avene Dacume Cont Cente WOU6.GHOD Sher Sing MD 2093-0002 January 16,2015 YTY Industry (MANJUNG) SDN. BHD. Mr. Andrew Lowery Official Correspondent QA/GMP Consultant 14004 Manor Road, P 0 Box 445 Phoenix, Maryland 21131 Re: K142283 ‘Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, $611F (M ) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H), Blue Color, $612F (C) Blue Color, 8604T Black Color and 8617F White Color] Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: 1 Product Code: LZA Dated: December 13, 2014 Received: December 8, 2014 Dear Mr. Lowery: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). ‘You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class Il (Special Controls) or class III (PMA), it ‘may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements conceming your device in the Federal Register.Page Mr, Andrew Lowery Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CER Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medic: device-relaied adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections $31-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet adde: Awww. fla, gov/MedicalDevices/ResourcesforYouw/Indusiry/defaul.him. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CER Part 803), please go to hitp://www. fla, gov/ Medical Devices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometries/Division of Postmarket Surveillance. You may obiain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address hitp:/Avww. fda. gov/Medical Devices/Resourcesfor¥owIndustry/default him. Sincerely yours, Tejashré Purohit Sheth MLD. Tejashii Purokit-Sheth, HD. Cisiea Deputy Dieecoe GRIDODEICDRH FOR Erin L. Keith, MS. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(i> ‘This is to ceriy that, in accordance with Hermit wird bestatigt, daft mdi Europa GmbH als either medical device Directive 93142/EEC Bevolimachtigter gems § 7 ‘a5 amended by 2007/47/EC or Directive Medizinproduktegesetz (MPG/nationale Umset- 98/7S/EC, mai Europa GmbH agree to per- __zung der Richtinie for Medizinprocukte form all duties and responsibilites as the {93/42/EWG gem, Anderungsrichtlnie Authorized Representative for 2007/47/EG tzw. 98/79/EG) for den Hersteller YTY Industry (Manjung) SDN BHD LOT 1422-1424, BATU 10 LEKIR, 32020 ,SITIAWAN, PERAK D. R. MALAYSIA {5 stipulated and demanded by the afore- die Anzeigepflicht ema § 25 MPG fur die mentioned Drectives. The German compe- rnachfolgend aufgefuhrten Medizinprodukte tent authorities have allocated the medical erful hat. Den angezeigten Mecizinprodukten ‘devices of the manutacturer the following sind de folgenden Registrierdaten zugeordnet registration numbers worden: Medical Device UMDNS Code Registration-No. Gloves, Examination/Treatment 11882 DEICA08/0760/374 ‘The manufacturer has provided mdi Europa Der Hersteller hat mdi Europa alle for das erst- with all necessary documentation, together alge Inverkehrbringen von Medizinprodukten with an appropriate Declaration of Confor- erforderichen Dokumente vorgelegt. Dazu ge- ‘ity confirming that the medical devices hort die Konformitatserklarung, die bestatigt, da fulfil the essential requirements of either die Produkte die grundiegenden Anforderungen Directive $3/42/EEC as amended by er Richtlinie 93/42/EWG gem. Anderungsrichtl 2007/47/EC or S8/79/EC. A safety officer nie 2007/47/EG baw. S8/79/EG erfullen. Ei hhas been appointed for Germany anc ‘Sicherheitsbeautragter gemag § 31 MPG wurde therefore isin full compliance with § 31 bestellt MPG. December 2012 Werner Sander President & CEO HE MEDICAL DEVICE SERVICE EMENmS = S iS & rH 3 = i=] a 7 Py I & a o a & 9 = Ss 8 S= = & oi 5 ths Silat wi ras tile Ve | CERTIFICATE The Certification Body of TUV SUD Management Service GmbH certifies that thas established and applies a Quality Management System for Design and Development, Production and Distribution of Medical Examination Gloves. and PPE Gloves. ‘An audit was performed, Report No. 70077382 Proof has been furnished that the requirements according to ISO 9001:2015 are fulfilled, ‘The certificate is valid from 2018-04-24 until 2021-01-31 Previous certificate valid until 2018-01-31 Certificate Registration No.: 12 100 23839 TMS, Product Compliance Management nich 2018-04:24 TOV $00 Management Service GmbH » Zorfiorugastoll Rdhstao 65 « 0399 NOrchae tue sued, mProgress Through innovation, Technology and Customer Satisfaction October 24, 2017 * TEST REPORT « PN 137347 CHEMICAL ANALYTICAL SERVICES Prepared For: ‘YTY industry (Manjung) SON. BHD. Punitha Samy Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Darul Ridzuan, Malaysia Ey be = Approved By: Gu CB yor cas iy Heller ‘Ana C. Barbur, MS. ask ile Veo Praschnt.Anaitce! Soreas Prepared By:_O\s ‘An A2LAAccredied Testing Laboratory — Certificate Numivers 295.01 8 255.02, =~ wa 180 900%:2008 Registered TSO 9001:2008 jw ardlcom | 2887 Gilchrist Rd. | Akron, Ohio-44305 | answersgardl.com | Toll Free (800) 830-Ai Fax (220) 794-6610 | Worldwide (220) 794Progress Through Innovation, Technology ax October 24, 2017 Punitha YTY Industry Sdn. Bhd, Page 1 of 4~ PN 137347 ‘SUBJECT: RECEIVED: Permeation testing per ASTM D 8976 on sample submitted by the above company. Glove sample identified a¢ On Line Chlorinated Blue Nitile Powder Free Examination Gloves ~ 32g Accelerator Free; Batch 723004E28, Size Medium, TESTING CHEMOTHERAPY DRUGS: Table 4 List of th ing Chemotherapy Dru n Dates TESTING CHEMOTHERAPY DRUGS ‘CHEMICAL SOURCE Carbopiatn “Teval Lote 16HI8KA: Expiration 08/2076 ‘Carmustine (BCNU) Cisplatin Cyclophosphamide (Cytoxan] ‘Sigma Alorich, Lote 037M4157V, Expires 082075 resenius Kabi, Low 6114571, 02/2016 igma Aldrich; Lote SLBG4216V, Expiration 12/2017 Dacarbazine (DTIC) Teva; Lott 313220828; Expiration 11/2010 Doxorubicin Hydrochionie Pfizer, Lot# S17209; Expration 09/2018 [ Etoposide (Toposar) Fluorouracil Hosfaride “Teva, Loté 313216868, Expiration 09/2019 “Accord, Lot PT04863; Expiration 11/2018 Sigma Alcrich; Lott 1061083V; Expiation 12/2017 Methotrexate “Teva, Lott 16A26MA, Expration 01/2018 ‘Mitomycin C ‘Sigma Aldrich; Lott SLBH6728V. Expiration OSDOTE Mitoxentrone: ‘Sigma Aloricn Lot AKBR22 10V. Expiration 03/2018) Paclitaxel (Taxol) Thiotepa Vincristine Sutate Hospira, Lott DO46BO5AA; Expiration 08/2016 USP; Lot# RO46RO: Expiration 04/201 —} ‘Sigma Aldrich; Lot# SLBQ9220V, Expiration 0172018, 1887 Gilchrist Ra. | Akron, Ohio Fax (330) 794-6610 jor ans Toll Free (800) 830-ARD ide (330) 794-6600Punitha YTY Industry Sdn. Bhd. Page 2 of 4- PN 137247 COLLECTION MEDIA: Table 2. Collection Media for Testing Chemotherapy Oras TEST CHEMICAL AND CONCENTRATION ‘COLLECTION MEDIUM Carboplatin, 10 mg/ml (10,000 ppm) Distiled Water ‘Garmustine (BCNU), 3.3 mg/ml (3,309 ppm) [10% Etanol Aqueous Souion Cispiatin, 1.0 mg/ml (1,000 ppm) Distiled Weter ‘Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000pom) Distiled Weter Dacerbazine (DTIC), 10.0 mgimi (10,000 ppm) Distiled Water ‘Doxorubicin Hydrochloride, 2.0 mg/mi (2,000 ppm) Distiled Weter Etoposide (Toposar), 20.0 mg/ml (20,000 pom) Distiled Water Fluorouracil, 50.0 mg/m (50,000 pom) 19.20 pH Sodium Hydraxide Solution osfarnide, $0.0 mg/ml (50,009 ppm) Distiled Water ‘Methotrexate, 25 ma/mi, (25,000 pom) Distilled Water Mitomycin C, 0.5 mg/ml (500 ppm) Distiled Water Nitoxantione, 2 mg/mi 2,000pm) Distiled Water Paclitaxel (Taxol), 6.0 mg/mi_(6,000 ppm) '30% Methanol Aqueous Solution Thiotepa, 10.0 mgim! (10,000 pom) Distiled Water Vincristine Sulfate, 0 mg/m (1,000 ppm) Distiled Water ECTION METHOD OF CHEMICAL PERMEATION: UV/ Instrument Perkin Elmer UVMIS Spectrometer Lambda 25 UVIMIS Absorption Spectrometry was used to measure the absorbance of test chemicals which permeated through the specrmens into the colection medium. The coliaction medium was circulated in a closed loop at 11 mlminute of flow cate through the testing period. Data collection was performed according to the programmed schedule by means (of UV Winlab software from the Perkin Elmer Corporation. The list of the charactersstc wavelengths is shown below. ble 3._ Characters nat in UVIVIS Absorption TESTING CHEMOTHERAPY DRUGS WAVELENGTH (om) 192 229. 198 200. 320 232 205, 269, 200. 303. 217 242 231 400 220 | carbopiatin (Carmustine Cisplatin, ‘Cyclophosphamide (Gyioxan) Dacarbazine (DTIC Doxorubicin Hydrochiorde Etoposide (Toposar} Fluorouract Hosfamige (Tex) Methotrexate [ Mitomycin C: Nitoxantione Facliaxel (Tax) Thiotapa VincristinePunitha ‘YTY Industry Sdn, Bhd, Page 3 of 4 PN 197347 ‘TESTING CONDITIONS: Standard Test Mothod Used: ASTMD 6978. Deviation From Standard Test Method Used 1" Permeation Cell ‘Analytical Method UVIS Spectrometry ‘Testing Temperature: 36.0°C 22.0 Collection System: (Closed Loop Specimen Area Exposed: 5.067 ema ‘Selected Data Points: 25/test Number of Specimens Tested 3itest Location Sampled From: Cuff area Comments/Other Conditions: Magnetic str bar was used in the sampling chamber ‘SAMPLE CHARACTERISTICS: Table 4. Thickness characteristics for he tested specimens on: Giove sample ientfied as On Line Chlorinated Bive Nivile Powder Free Examination Gloves ~ 3.29 Accelerator Free: Batch# 722004828; Size Medium, Testing 7 Thickness (mm) #2 Chemotherapy Drugs _ sphamide (cyioxan) | — | Dacaroazine (OTC) Doxorubicin Hyd aposide (Toposar) [Fiuorourect | 314 [ Mitoxantrone: [ Pacitaxel (Taxol) Thiotepa, VincristingPunitha ‘YTY Industry Sdn. Bhd. Page 4 of 4— PN 197347 Sn: son n Line Ch 10 Nile Powd Medium TaN AVERAGE TEST CHEMOTHERAPY DRUG | BREAKTHROUGH | STEADY STATE OTHER "AND CONCENTRATION DETECTION TIME | PERM.RATE | OBSERVATIONS. (Specimenti2/3) | (Specimonti2/3) (Minutes) (ugler#iminuto) Carboplatin, No Breakthrough up NA Sight swoling and 40 mgiml (10,000 ppm) to 240 min, No degradation ‘Carmustine (SCNU) 113 oz Maderete sweing 3.3 mg/m (3,300 ppm) (116,113,135 (02,0203) | and no degradation Cisplatin, lo breakthrough up NA ‘Sight sweling and 4.0 mg/m (1,000 perm) to 240 min no degradation Cycioonosphamide (Cytoxany, No breaktnrough up NA Sight sweling and 20,0 mall (20,000ppm) to 240 min, No degradation Decarbezine (OTIC), No breakthrough up WA Sight sweling and 40.0 mg/ml (40,000 pom) to 240 min. | |__no degradation Doxorubicin Hydrochioride, No Breakthrough up | WA Bight sweling and 2.0 mg/ml (2,000 ppm 0 240 min | “no degradation Etoposide (Toposar), No breakthrough up NA ‘Slight swelling and 20.0 majml (20,000 pom) to 240 min, 1 degradation Fluoroursc, No breakthrough up WA Sight sweling and 50,0 mgiml (50,000 pom) e240 min no degradatin Tiostamie, No breakthrough up Wa Sight eweling and ‘50.0 mgiml (50,000 pom) 0 240 min, No degradation Methovexae No breakthrough up WA Sight sweting and 25 mg/m, (25,000 ppm) to 240 min No degradation Mitomyein No breakthrough up WA Sight sweling and | 0.5 mgimt (600 pom) 0 240 min no degradation Mitoxantrore, ‘No breakthrough up wa Sight sweling and 2 male (2,900ppm) 10240 min no degradation Pacitaxel Taxa), No breakthrough up WA Moderate sweling 6.0 maim! (6,000 ppm) 0240 min. — and no degradation Thictepa, 74 oa ‘Sight sweling and 10.0 mgim! (10,000 pen) (188,7.4.118) (04,0304) no degradation Vineristine Sulfate Tio breakthrough Up NA Sight sweling and 1.0 maim (1,000 ppm 10 240 min ‘no degradation Aw CPB lncng Het ‘Ana C. Barbur, M.S, lanager Vice Presdect Brarnscautial Soricos ‘Araiyical Servoes AKRON RUBBER DEVELOPMENT LABORATORY, INC.=] YTY INDUSTRY DECLARATION OF CONFORMITY We, YIY INDUSTRY (MANJUNG) SDN BHD address, Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan, Perak Darul Ridzuan, Malaysia declare under our sole responsibility that Powder Free Nitrile Medical Examination gloves supplied by us are in conformity to the following standards: Medical Gloves for Single Use EN 455 Part 1: 2000 EN 455 Part 2: 2015, EN 455 Part 3: 2015, EN 455 Part 4: 2009 Protective Gloves against chemicals and micro-organisms EN 374-1:2003 — excluding clause 5.3.2 EN 374-3:2003 Protective Gloves EN 388:2003 EN 420:2003+A1:2009 La ‘Chow Choong Keong -QA Manager 11" May 2017 pron,