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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 K994250
Device Name TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Tekmedic (M) Sdn Bhd
6324 Meetinghouse Way
Alexandria,  VA  22312 -1718
Applicant Contact KOK-KEE HON
Correspondent
Tekmedic (M) Sdn Bhd
6324 Meetinghouse Way
Alexandria,  VA  22312 -1718
Correspondent Contact KOK-KEE HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/16/1999
Decision Date 02/07/2000
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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