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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K212438
Device Name Comfortpro
Applicant
Thai Rubber Industry Company Limited
738 Moo 5, Manam Koo
Pluakdaeng,  TH 21140
Applicant Contact Chawalit Tiyadechachai
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114,
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/04/2021
Decision Date 12/07/2021
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
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