Revision no.

:
10
TECHNICAL FILE
Date:
31st December
2019
Doc No.:
TOP-TF-NPF
PART B
NITRILE EXAMINATION Page:
POWDER FREE GLOVE 1 of 1

Table of content Title

Annex 1 Essential Requirement Report

Annex 2 Risk Management Report

Annex 3 Sketch Diagram

Annex 4 Product Specification Standard Compliance

Annex 5 Biological Evaluation Report

- Biocompatibility Testing
Annex 6 Manufacturing Flow
Annex 7 Chemical Composition
Annex 8 Clinical Evaluation Report
Annex 9 Declaration of Conformity