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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 K891660
Device Name PROLIFE PATIENT EXAMINATION GLOVES (LATEX)
Applicant
B J L Glove (M) Sdn. Bhd.
Lot 28 & 30, Jalan 16/11,
Shah Alam
Selangor,  MY 40000
Applicant Contact LIN CHIANG
Correspondent
B J L Glove (M) Sdn. Bhd.
Lot 28 & 30, Jalan 16/11,
Shah Alam
Selangor,  MY 40000
Correspondent Contact LIN CHIANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/1989
Decision Date 06/06/1989
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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