(92 days)
The Powder Free Latex Examination Glove Coated with Skin-care Ingredients is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.
The provided text describes the acceptance criteria and performance of Powder Free Latex Examination Gloves. It does not pertain to an AI device or a study involving human readers. Therefore, I will extract the available information related to the acceptance criteria and device performance from the provided document.
Here's the information as requested, adapted to the content of the document:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from Pinhole | ASTM D 3578 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM 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.