Clearance Summary
Polyisoprene Powder Free, Black Colour Surgical Gloves received FDA 510(k) clearance under submission number K192933, sponsored by Emerson & Co. Srl. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-01-13.
- Submission: K192933
- Applicant / Sponsor: Emerson & Co. Srl
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2021-01-13
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.