Clearance Summary
DISPOSABLE SHOE COVER received FDA 510(k) clearance under submission number K913628, sponsored by Gem Nonwovews, 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 1991-10-04.
- Submission: K913628
- Applicant / Sponsor: Gem Nonwovews, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-10-04
Classification & Regulation
This clearance is catalogued under FDA product code FXP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.