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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K212011
Device Name Vinyl Powder Free Examination Glove
Applicant
Top Glove Vietnam Company Limited
Lot A_8b_Cn, St. N3, Bau Bang Industrial Zone,
Lai Uyen Town
Bau Bang,  VN 75000
Applicant Contact Natrisya Nur Binti Abdul Rahman
Correspondent
Tg Medical USA (Inc)
165 N. Aspen Ave.
Azusa,  CA  91702
Correspondent Contact David Lim
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/28/2021
Decision Date 02/14/2022
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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