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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 K974870
Device Name LATEX EXAMINATION GLOVE POWDER FREE
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 Received12/29/1997
Decision Date 03/13/1998
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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