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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K253060
Device Name Sterile Latex Powder Free Surgical Gloves
Applicant
Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang
Rayong,  TH 21140
Applicant Contact Nathaphon Wachakorn
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Kiwi Xu
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/22/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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