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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 K212085
Device Name Siam NTD+ Nitrile Powder-Free Examination gloves
Applicant
Siam Ntd Corporation Co., Ltd.
120/259 Moo 1
Bueng Yitho Thanyaburi,  TH 12130
Applicant Contact Taweesak Waideemaneetrakoon
Correspondent
Third Party Review Group
25 Independence Blvd. Warren,
None,  NJ  07059
Correspondent Contact Taweesak Waideemaneetrakoon
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/02/2021
Decision Date 12/11/2021
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
Predetermined Change
Control Plan Authorized		 No
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