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510(k) Data Aggregation
K Number
K093576Manufacturer
Date Cleared
2010-03-04
(106 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
Why did this record match?
Device Name :
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Powder Free Vinyl Patient Examination Gloves, White Color is a non-sterile 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
Powder Free Vinyl Patient Examination Gloves, White Color that meets all of the requirements of ASTM standard D 5250-06e1.
AI/ML Overview
This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets ( |
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