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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 K092492
Device Name POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
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
LYY  
Date Received08/13/2009
Decision Date 10/21/2009
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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