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510(k) Data Aggregation
K Number
K032783Date Cleared
2003-11-13
(66 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Powdered vinyl 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.
Device Description
powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.
AI/ML Overview
Acceptance Criteria and Study for Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves
This document summarizes the acceptance criteria and the study conducted to demonstrate that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves meet these criteria, as described in the provided 510(k) summary (K032783).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatibility - Primary Skin Irritation | Primary Skin Irritation in rabbits (Passes: Not a Primary Skin Irritation) |
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