(60 days)
The Powder-Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with Protein Labeling Claim (50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s) to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.
Class I powder free latex examination gloves with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.
Acceptance Criteria and Device Performance Study for Powder Free Latex Examination Gloves
This report details the acceptance criteria and the study that proves the performance of the "Powder Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less)" by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (K042645).
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against established ASTM standards and FDA regulations. The following table summarizes the acceptance criteria and the reported performance of the device:
| Characteristics | Standards | Acceptance Criteria (Implied by "Meets" or specified values) | Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 3578-01 | Meets ASTM D 3578-01 requirements | Meets |
| Physical Properties | ASTM D 3578-01 | Meets ASTM D 3578-01 requirements | Meets |
| Freedom from Pinholes | ASTM D 3578-01 | Meets ASTM D 3578-01 requirements | Meets |
| FDA 21 CFR 800.20 | Meets FDA 21 CFR 800.20 requirements | 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.