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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 K231446
Device Name Single-Use Latex Sterile Surgical Gloves (SG100)
Applicant
Fitone Latex Products Co., Ltd. Guangdong
#5 Huitong Rd., Lingbei Industrial Zone, Suixi
Zhanjiang,  CN 524338
Applicant Contact Christine Ou
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz., W. Guangzhong Rd.
555, Jingan District
Shanghai,  CN 200072
Correspondent Contact Kyra Kang
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/18/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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