Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

Latex Patient Examination Glove

Hebei Titans Hongsen Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd. with the FDA for Disposable Medical Rubber Examination Gloves (xs/s/m/l/xl).

Pre-market Notification Details

Device IDK221374
510k NumberK221374
Device Name:Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
ClassificationLatex Patient Examination Glove
Applicant Hebei Titans Hongsen Medical Technology Co., Ltd. Eastern Industrial Zone, Nangong City Xingtai,  CN 051800
ContactChai Wu
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-12
Decision Date2022-10-26

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