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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 K203191
Device Name LYDUS Nitrile Examination Gloves, Powder Free
Applicant
Nathan Trading Co., Ltd.
58 Moo 12 Palan Sub-District
Nathan District,  TH 34170
Applicant Contact Chansamone Saiyasak
Correspondent
Global Quality and Regulatory Services
10 Scenic Way
Monroe,  NJ  08831
Correspondent Contact Abdel B. Halim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/27/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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