(23 days)
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 | - |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.