Purism Non-Sterile Powder Free Nitrile Examination Gloves

Polymer Patient Examination Glove

Dezhou Purism Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Dezhou Purism Medical Technology Co., Ltd. with the FDA for Purism Non-sterile Powder Free Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK211319
510k NumberK211319
Device Name:Purism Non-Sterile Powder Free Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Dezhou Purism Medical Technology Co., Ltd. High-end Equipment Manufacturing Park, Minsheng North Road, Economic Development Zone Dezhou,  CN 253100
ContactTing Luo
CorrespondentNatalya Valerio
mdi Consultants, Inc. 55 Northern Blvd., Suite 201 Great Neck,  NY  11021
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-30
Decision Date2021-08-19

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