Clearance Summary
ComfortGuard Surgical Isolation Gown received FDA 510(k) clearance under submission number K210131, sponsored by Gri-Alleset, Inc.. 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 2021-08-26.
- Submission: K210131
- Applicant / Sponsor: Gri-Alleset, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-08-26
Classification & Regulation
This clearance is catalogued under FDA product code FYC and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.