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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 K892632
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Mlb Holdings Sdn. Bhd.
13a, Jalan 20/14, Paramount
Garden, 46300 Petaling Jaya
Selangor Darul Ehsan,  MY
Applicant Contact Y. Y HEONG
Correspondent
Mlb Holdings Sdn. Bhd.
13a, Jalan 20/14, Paramount
Garden, 46300 Petaling Jaya
Selangor Darul Ehsan,  MY
Correspondent Contact Y. Y HEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 08/21/1989
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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