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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 K922255
Device Name LATEX EXAMINATION GLOVES
Applicant
Balak Rubber (Malaysia) Sdn. Bhd.
Lot 478 & 479, Jalan Simpang,
Off Batu 13, Jalan Cheras,
Malaysia,  MG
Applicant Contact BASKARAN
Correspondent
Balak Rubber (Malaysia) Sdn. Bhd.
Lot 478 & 479, Jalan Simpang,
Off Batu 13, Jalan Cheras,
Malaysia,  MG
Correspondent Contact BASKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/01/1992
Decision Date 10/01/1992
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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