(35 days)
The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile 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.
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.
The medical device in question is the "Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile." The study described is a non-clinical performance evaluation comparing the device's characteristics against established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00 & FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 |
§ 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.