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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K222693
Device Name Single-use medical latex examination gloves (LG100)
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.
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN 200072
Correspondent Contact Stuart Situ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/06/2022
Decision Date 09/24/2022
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
Predetermined Change
Control Plan Authorized		 No
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