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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 K213075
Device Name Goody Gloves, Wincare, TBG Gloves
Applicant
Thai Rubber Gloves Co., Ltd.
680 Moo 2 Banbueng-Klaeng Rd.
Nongyai,  TH 20190
Applicant Contact Chalongkwan Wongsasuthikul
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114,
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/23/2021
Decision Date 01/20/2022
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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