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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K990883
Device Name LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
Applicant
La Glove (M) Sdn. Bhd.
Jalan Simpang Balak, Off Batu
13, Jalan Cheras, 43000 Kajang
Selangor Darul Ehsan Mala,  MG
Applicant Contact G. BASKARAN
Correspondent
La Glove (M) Sdn. Bhd.
Jalan Simpang Balak, Off Batu
13, Jalan Cheras, 43000 Kajang
Selangor Darul Ehsan Mala,  MG
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/16/1999
Decision Date 08/10/1999
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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