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.
|Device Name:||Purism Non-Sterile Powder Free Nitrile Examination Gloves|
|Classification||Polymer Patient Examination Glove|
|Applicant||Dezhou Purism Medical Technology Co., Ltd. High-end Equipment Manufacturing Park, Minsheng North Road, Economic Development Zone Dezhou, CN 253100|
mdi Consultants, Inc. 55 Northern Blvd., Suite 201 Great Neck, NY 11021
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|