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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 K971403
Device Name SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE
Applicant
Sj Medical Products (M) Sdn Bhd
Lot 723, Batu 5 1/2, Jalan
Kapar, Klang
Selangor Darul Ehsan,  MY 42100
Applicant Contact FOO KNON PU
Correspondent
Sj Medical Products (M) Sdn Bhd
Lot 723, Batu 5 1/2, Jalan
Kapar, Klang
Selangor Darul Ehsan,  MY 42100
Correspondent Contact FOO KNON PU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/15/1997
Decision Date 05/29/1997
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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