Clearance Summary
Aero Blue Performance Surgical Gowns received FDA 510(k) clearance under submission number K192362, sponsored by O&M Halyard, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-12-13.
- Submission: K192362
- Applicant / Sponsor: O&M Halyard, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2019-12-13
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.