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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 K012856
Device Name STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
Applicant
Smart Glove Corp. Sdn Bhd
Lot 6487 Batu 5 3/4
Jalan Kapar
Klang Selangor,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
Smart Glove Corp. Sdn Bhd
Lot 6487 Batu 5 3/4
Jalan Kapar
Klang Selangor,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/24/2001
Decision Date 11/16/2001
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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