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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 K213604
Device Name ELAZ Nitrile Powder Free Examination Glove
Applicant
Protect Gloves Co., Ltd.
60/138 Moo 3 Mabyangporn
Pluakdang,  TH 21140
Applicant Contact Nathaphon Wachakorn
Correspondent
MDR Solutions Co., Ltd.
1435 Kanchanapisek Rd., Bang Khae Nuea
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/15/2021
Decision Date 04/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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