Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

Zhonghong Pulin Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Zhonghong Pulin Medical Products Co., Ltd. with the FDA for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK171873
510k NumberK171873
Device Name:Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Zhonghong Pulin Medical Products Co., Ltd. Pachigang Industrial Park, Luannan County Tangshan,  CN 063502
ContactJinge Li
CorrespondentDa Shi
Zhonghong Pulin Medical Products Co.,Ltd. 800 - 10 Four Seasons Place Toronto,  CA M9b 6h7
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-23
Decision Date2017-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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20686864060110 K171873 000

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