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510(k) Data Aggregation
K Number
K053259Device Name
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
Manufacturer
Date Cleared
2006-01-18
(57 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD.
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 personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
Class I powder-free patient examination glove LYZ, meets all of the requirements of ASTM Standard D5250-00E1. Class I powdered patient examination glove, LYZ, also meets all the requirements of ASTM Standard D5250-00E1. as well as all the requirements of ASTM Standard D6124-01 for powdered glove and its residue powder.
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