Clearance Summary
FlexGard Cut-Resistant Glove Liners received FDA 510(k) clearance under submission number K190782, sponsored by Ldi Corporation. 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 2019-06-27.
- Submission: K190782
- Applicant / Sponsor: Ldi Corporation
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2019-06-27
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.