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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 K210656
Device Name ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Applicant
Careplus (M) Sdn Bhd
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
Seremban,  MY 70450
Applicant Contact Lim Kwee Shyan
Correspondent
Careplus (M) Sdn Bhd
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
Seremban,  MY 70450
Correspondent Contact Lim Kwee Shyan
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received03/04/2021
Decision Date 06/24/2021
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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