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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 K012880
Device Name STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
Applicant
Ssn Gloves (M) Sdn Bhd
# 1, Jalan 203, Off Jalan
Tandang
Petaling Jaya, Selangor,  MY 46050
Applicant Contact CLINTON A TECK LEONG
Correspondent
Ssn Gloves (M) Sdn Bhd
# 1, Jalan 203, Off Jalan
Tandang
Petaling Jaya, Selangor,  MY 46050
Correspondent Contact CLINTON A TECK LEONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/28/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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