(205 days)
Intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
USA Gloves Nitrile Gloves and aforementioned predicate device are Non-powdered patient examination glove, as defined in 21 CFR 880.6250. Former Release Powder or Chemical: No release powder or chemical is used. USA Gloves Nitrile Gloves is not intended to be sterilized. The device is delivered in packaging which may be used as a protective carrying case.
The document provided is a 510(k) Premarket Notification from the FDA for USA Gloves Nitrile Powder Free Exam Gloves (K211624). This type of document is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical studies with "AI" components or human readers improving with AI assistance. As such, many of the requested categories (2-9) are not applicable or cannot be extracted from this specific type of regulatory submission.
Here's the information that can be extracted and a clear indication where the requested information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTMD 6319-10 (Reapproved 2015) | Physical Properties: Before Aging Tensile Strength min 14 Mpa, Ultimate Elongation Min 500%; After Aging Tensile Strength min 14 Mpa, Ultimate Elongation Min 400% | Pass |
| ASTMD 6319-10 (Reapproved 2015) | Dimensions: Length Min 230 mm, Width Min 95+/-10mm (for medium size) | Pass |
| ASTMD 6319-10 (Reapproved 2015) | Thickness: Palm min 0.05 mm, Finger min 0.05 mm | Pass |
| ASTMD 6319-10 (Reapproved 2015) | Powder Residue: |
§ 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.