The following data is part of a premarket notification filed by Usa Gloves with the FDA for Usa Gloves Nitrile Powder Free Exam Gloves.
| Device ID | K211624 |
| 510k Number | K211624 |
| Device Name: | USA Gloves Nitrile Powder Free Exam Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | USA Gloves 12505 Reed Rd Ste 110 Sugar Land, TX 77478 |
| Contact | Zishan Momin |
| Correspondent | Zishan Momin USA Gloves 12505 Reed Rd Ste 110 Sugar Land, TX 77478 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2021-12-18 |