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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 K912988
Device Name LATEX EXAMINATION GLOVES
Applicant
La Glove (M) Sdn. Bhd.
Jalan Simpang Balak, Off Batu
13, Jalan Cheras, 43000 Kajang
Selangor Darul Ehsan Mala,  MG
Applicant Contact LOT 478
Correspondent
La Glove (M) Sdn. Bhd.
Jalan Simpang Balak, Off Batu
13, Jalan Cheras, 43000 Kajang
Selangor Darul Ehsan Mala,  MG
Correspondent Contact LOT 478
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/05/1991
Decision Date 08/02/1991
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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