Search Results
Found 1 results
510(k) Data Aggregation
(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: |
Ask a specific question about this device
Page 1 of 1