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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K013317
Device Name TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Tekmedic (M) Sdn Bhd
P.O. Box 11112
Alexandria,  VA  22312
Applicant Contact KOK-KEE HON
Correspondent
Tekmedic (M) Sdn Bhd
P.O. Box 11112
Alexandria,  VA  22312
Correspondent Contact KOK-KEE HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/04/2001
Decision Date 12/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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