(58 days)
Latex Examination Gloves, Powdered, Blue, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.
The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.
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1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS (Acceptance Criteria) | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578 – 01ae2 | Meets |
| Physical Properties | D 3578 - 01ae2 | Meets |
| Freedom from Pinholes | D 3578 - 01ae2, FDA 21 CFR 800.20 | Meets |
| Powder Amount | D 3578 - 01ae2, D 6124 - 01 |
§ 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.