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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K093500
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
Applicant
Wear Safe (Malaysia) Sdn. Bhd.
Lot Pt 13726,Jalan Haji Salleh
Off Jalan Meru
Klang, Selangor Darul Ehsan,  MY 41050
Applicant Contact S.H. TAN
Correspondent
Wear Safe (Malaysia) Sdn. Bhd.
Lot Pt 13726,Jalan Haji Salleh
Off Jalan Meru
Klang, Selangor Darul Ehsan,  MY 41050
Correspondent Contact S.H. TAN
Regulation Number880.6250
Classification Product Code
LZC  
Date Received11/12/2009
Decision Date 01/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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