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510(k) Data Aggregation
(23 days)
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
This document describes the performance data for KOH2101, Powder Free Nitrile Examination Gloves, manufactured by SEAL Polymer Industries Berhad. The device is a Class 1 Nitrile Patient Examination Glove intended for medical purposes to prevent contamination between patients and examiners. The performance data is based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | ASTM D6319-00aE3 Acceptance Criteria (AQL=2.5%) | KOH2101 Powder Free Nitrile Exam Gloves Reported Performance (AQL=2.5%) |
|---|---|---|
| 1. Watertight (1000 ml) | G I | Pass G I |
| 2. Length (mm) | ||
| XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm) | ||
| XS | - |
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