The following data is part of a premarket notification filed by Dong Nai Garment Corporation (donagamex) with the FDA for Donagamex Blue Performance Protective Gown.
| Device ID | K203821 |
| 510k Number | K203821 |
| Device Name: | Donagamex Blue Performance Protective Gown |
| Classification | Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection |
| Applicant | Dong Nai Garment Corporation (Donagamex) Road 2, Bien Hoa Industrial Zone 1 An Binh Ward Bien Hoa City, VN 810000 |
| Contact | Bui The Kich |
| Correspondent | Bari Steinberg mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | QPC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-29 |
| Decision Date | 2021-12-17 |