The following data is part of a premarket notification filed by Safeskin Retailing (hk) Limited with the FDA for Black Nitrile Powder Free Patient Examination Glove, Non Sterile.
| Device ID | K222715 |
| 510k Number | K222715 |
| Device Name: | Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | Safeskin Retailing (HK) Limited 26th Floor, Beautiful Group Tower, 77 Connaught Road Central Hong Kong, CN |
| Contact | Alvin Ho |
| Correspondent | Stephan Toupan Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, FL 33126 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-12-03 |