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510(k) Data Aggregation
K Number
K032907Manufacturer
Date Cleared
2003-11-20
(64 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
Why did this record match?
Device Name :
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
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 5250-0064
AI/ML Overview
This document describes the acceptance criteria and the study conducted to demonstrate that the medical device in question, "FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, White (Non-colored)," meets these criteria.
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 |
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