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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 K991624
Device Name POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
Applicant
Smart Glove Corp. Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
Smart Glove Corp. Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/11/1999
Decision Date 07/09/1999
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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