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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 K171276
Device Name Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
Applicant
Tg Medical Sdn. Bhd.
Lot 5091, Jalan Teratai
Batu 5, Off Jalan Meru
Klang,  MY 41050
Applicant Contact Fatima Wati BT Mohamad
Correspondent
Tg Medical Sdn. Bhd.
Lot 5091, Jalan Teratai
Batu 5, Off Jalan Meru
Klang,  MY 41050
Correspondent Contact Fatima Wati BT Mohamad
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received05/01/2017
Decision Date 08/21/2017
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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