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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 K222129
Device Name Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Applicant
Top Glove Medical (Thailand) Co., Ltd.
188, 189, 190 Moo 5 Kanchanawanich Rd., Tambol Sumnakkhan
Amphur Sadao,  TH 90320
Applicant Contact Shahana Parveen Binti Ridzam Shah
Correspondent
Tg Medical (Usa), Inc.
165, N. Aspan Ave.
Azusa,  CA  91702
Correspondent Contact David Lim
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received07/18/2022
Decision Date 02/10/2023
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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