Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

Polymer Patient Examination Glove

Humanwell Healthcare Group Medical Supplies Co., Ltd.

The following data is part of a premarket notification filed by Humanwell Healthcare Group Medical Supplies Co., Ltd. with the FDA for Medical Examination Gloves (nitrile) (xs, S, M, L, Xl).

Pre-market Notification Details

Device IDK222498
510k NumberK222498
Device Name:Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
ClassificationPolymer Patient Examination Glove
Applicant Humanwell Healthcare Group Medical Supplies Co., Ltd. 14th F, 1500# Century Avenue Wuhan,  CN
ContactAixue Yao
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai,  CN 200122
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-18
Decision Date2022-10-26

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