The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal Corporation Aami Level 4 Open-back Protective Gown.
| Device ID | K212464 |
| 510k Number | K212464 |
| Device Name: | Dukal Corporation AAMI Level 4 Open-Back Protective Gown |
| Classification | Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection |
| Applicant | Dukal Corporation 2 Fleetwood Court Ronkonkoma, NY 11779 |
| Contact | Megan Quevedo |
| Correspondent | Megan Quevedo Dukal Corporation 2 Fleetwood Court Ronkonkoma, NY 11779 |
| Product Code | QPC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-06 |
| Decision Date | 2022-03-30 |