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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K202003
Device Name Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Applicant
Gmp Medicare Sdn. Bhd.
Lot/Pt 64593, Jalan Dahlia/Ku8, Kawasan
Perindustrian Meru Timur,
Klang,  MY 41050
Applicant Contact Noraini Binti
Correspondent
Tg Medical USA (Inc)
165 N. Aspen Ave.
Azusa,  CA  91702
Correspondent Contact David Lim
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received07/20/2020
Decision Date 02/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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