(316 days)
The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.
The provided text describes a 510(k) summary for "Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim". This is a medical device application for examination gloves, which falls under a different category than typical AI/ML medical devices that require the types of studies listed in the prompt.
Therefore, many of the requested elements are not applicable to this 510(k) submission. Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | 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.