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510(k) Data Aggregation
K Number
K123469Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
Manufacturer
WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II
Date Cleared
2013-02-19
(98 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile meets all of the requirements of ASTM D 6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or white color.
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