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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 K221374
Device Name Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Applicant
Hebei Titans Hongsen Medical Technology Co., Ltd.
Eastern Industrial Zone, Nangong City,
Xingtai,  CN 051800
Applicant Contact Chai Wu
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/12/2022
Decision Date 10/26/2022
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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