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510(k) Data Aggregation
K Number
K053657Manufacturer
Date Cleared
2006-02-13
(70 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.
Device Description
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.
AI/ML Overview
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimension | D 6319-00aE3 | Meets |
| Physical Properties | D 6319-00aE3 | Meets |
| Freedom from Pinholes | D 6319-00aF3 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residue | D 6319-00aE3 | |
| D6124 - 01 |
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