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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 K012558
Device Name POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
Applicant
Matang Mfg. Sdn. Bhd.
6324 Meetinghouse Way
Alexandria,  VA  22312
Applicant Contact KOK-KEE HON
Correspondent
Matang Mfg. Sdn. Bhd.
6324 Meetinghouse Way
Alexandria,  VA  22312
Correspondent Contact KOK-KEE HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/08/2001
Decision Date 09/17/2001
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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