Vinyl Patient Examination Glove (Yellow)

Vinyl Patient Examination Glove

Yurun Glove Co., Ltd.

The following data is part of a premarket notification filed by Yurun Glove Co., Ltd. with the FDA for Vinyl Patient Examination Glove (yellow).

Pre-market Notification Details

Device IDK173561
510k NumberK173561
Device Name:Vinyl Patient Examination Glove (Yellow)
ClassificationVinyl Patient Examination Glove
Applicant Yurun Glove Co., Ltd. No. 10 Zhaocai Street, Luannan County Shitangshan,  CN 063000
ContactChao Kevin
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing,  CN 102401
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-17
Decision Date2018-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860002339603 K173561 000

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