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510(k) Data Aggregation
K Number
K102171Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2010-11-16
(106 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WUXI BINGFA GAINLITE GLOVES CP., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Device Description
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
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