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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 K913409
Device Name LATEX EXAMINATION GLOVES
Applicant
Top Glove Sdn. Bhd.
24, Jalan Raja Mokhtar Dua
42200 Kapar, Selangor D.E.
Malaysia,  ML
Applicant Contact BEE TONG
Correspondent
Top Glove Sdn. Bhd.
24, Jalan Raja Mokhtar Dua
42200 Kapar, Selangor D.E.
Malaysia,  ML
Correspondent Contact BEE TONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/30/1991
Decision Date 09/27/1991
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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