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510(k) Data Aggregation
K Number
K050528Manufacturer
Date Cleared
2005-05-19
(78 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
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a"3 and FDA Water Leak Test.
AI/ML Overview
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00aE3) | Reported Device Performance (Powder Free Nitrile Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | Depends on size: | Depends on size: |
| Size XS | - |
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