Clearance Summary
Donagamex Blue Performance Protective Gown received FDA 510(k) clearance under submission number K203821, sponsored by Dong Nai Garment Corporation (Donagamex). The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-12-17.
- Submission: K203821
- Applicant / Sponsor: Dong Nai Garment Corporation (Donagamex)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-12-17
Classification & Regulation
This clearance is catalogued under FDA product code QPC and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.