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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 K000555
Device Name TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
Applicant
Tekmedic (M) Sdn Bhd
6324 Meetinghouse Way
Alexandria,  VA  22312
Applicant Contact KOK-KEE HON
Correspondent
Tekmedic (M) Sdn Bhd
6324 Meetinghouse Way
Alexandria,  VA  22312
Correspondent Contact KOK-KEE HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/18/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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