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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K011066
Device Name STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
Applicant
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Applicant Contact NG-YEW SOON
Correspondent
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Correspondent Contact NG-YEW SOON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/09/2001
Decision Date 09/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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