The following data is part of a premarket notification filed by Honeywell Safety Products with the FDA for Surgical Mask.
| Device ID | K211497 |
| 510k Number | K211497 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Honeywell Safety Products 10 Thurber Boulevard Smithfield, RI 02917 |
| Contact | Ivy Pettis |
| Correspondent | Ivy Grieco Honeywell Safety Products 10 Thurber Boulevard Smithfield, RI 02917 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2021-07-28 |