(83 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
The powder-free latex exam glove with vitamin E and aloe meets the current specifications for ASTM D 3578-00a. The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
The provided document is a 510(k) summary for a medical device, specifically the "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove with Vitamin E and Aloe. It outlines the device's characteristics and its equivalence to a predicate device, as well as the FDA's approval.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance | Comments |
|---|---|---|---|
| Dimensions | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Physical Properties | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Freedom from pinholes | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Meets ASTM D 5151-99 | Meets ASTM D 5151-99 | Confirmed | |
| Powder Free | Meets ASTM D 6124-00a | Meets ASTM D 6124-00a | Confirmed |
| Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed | |
| Protein Content | Meets ASTM D 5712-99 ( |
§ 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.