(35 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This product is a Class I medical device, which means it has a low-risk profile and generally doesn't require extensive clinical trials or complex AI performance studies. The provided document is about a physical product (gloves), not an AI/ML powered device, so many of the requested categories related to AI/ML studies are not applicable.
Here's the breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 el | Meets |
| Physical Properties | ASTM standard D 5250-06 el | Meets |
| Freedom from Pinhole | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el AND D6124-06 | Meets ( |
§ 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.