Vinyl Patient Examination Gloves

Vinyl Patient Examination Glove

Ping An Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Ping An Medical Products Co., Ltd. with the FDA for Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK182115
510k NumberK182115
Device Name:Vinyl Patient Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Ping An Medical Products Co., Ltd. Zhe Ji Road, High-tech Industrial Zone Of Hukou County Jiu Jiang,  CN 332000
ContactFu Dong Zhang
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-06
Decision Date2018-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20686864046404 K182115 000
20686864001540 K182115 000
20686864001557 K182115 000
20686864014793 K182115 000
00686864059592 K182115 000
00686864059516 K182115 000
20686864015615 K182115 000
20686864046381 K182115 000
20686864046398 K182115 000
20686864001526 K182115 000

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