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510(k) Data Aggregation
K Number
K990186Device Name
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
Date Cleared
1999-06-21
(152 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**SHANGHAI INTCO. PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for A pacience chaminat is worn on the examinaer's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80 LZA and meets all requirements of ASTM D3578-95.
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