The following data is part of a premarket notification filed by Ammex Corporation with the FDA for Powder Free Nitrile Examination Gloves (blue, Black, Indigo).
| Device ID | K211457 |
| 510k Number | K211457 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ammex Corporation 1019 W James St, Suite 200 Kent, WA 98032 |
| Contact | Sasitharan Nair |
| Correspondent | Davendran Tangaya Ammex Corporation 1019 W James St, Suite 200 Kent, WA 98032 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-12-18 |