Clearance Summary
AOR-SULLIVAN PROTECTIVE OVERGLOVE received FDA 510(k) clearance under submission number K893118, sponsored by Aor-Sullivan. 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 1989-06-01.
- Submission: K893118
- Applicant / Sponsor: Aor-Sullivan
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1989-06-01
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.