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 ID | K211319 |
| 510k Number | K211319 |
| 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 |
| Contact | Ting Luo |
| Correspondent | Natalya Valerio mdi Consultants, Inc. 55 Northern Blvd., Suite 201 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-08-19 |