MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS

Latex Patient Examination Glove

MATANG MFG. SDN. BHD.

The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Matang Powdered Latex Patient Examination Glove With Protein Labeling Claim (50 Microgram Or Less.

Pre-market Notification Details

Device IDK000985
510k NumberK000985
Device Name:MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
ClassificationLatex Patient Examination Glove
Applicant MATANG MFG. SDN. BHD. 6324 MEETING HOUSE WAY Alexandria,  VA  22312 -1718
ContactKok-kee Hon
CorrespondentKok-kee Hon
MATANG MFG. SDN. BHD. 6324 MEETING HOUSE WAY Alexandria,  VA  22312 -1718
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-27
Decision Date2000-04-24

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