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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 K212850
Device Name ComfortPro Blue Nitrile Examination Gloves Powder Free
Applicant
Thai Rubber Industry Company Limited
738 Moo 5, Manam Koo
Pluakdaeng,  TH 21140
Applicant Contact Supawadee Phoungthong
Correspondent
Liberty Management Group , Ltd.
75 Executive Dr., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/07/2021
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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