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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 K172420
Device Name Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Applicant
Wear Safe (Malaysia) Sdn. Bhd.
Lot 5068 & 5069, Batu 4 1/2, Jalan Meru
Klang,  MY 41050
Applicant Contact Cho Sow Fong
Correspondent
Wear Safe (Malaysia) Sdn. Bhd.
Lot 5068 & 5069, Batu 4 1/2, Jalan Meru
Klang,  MY 41050
Correspondent Contact Cho Sow Fong
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received08/10/2017
Decision Date 09/29/2017
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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