Clearance Summary
Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential received FDA 510(k) clearance under submission number K191860, sponsored by Semperit Technische Produkte Gesellchaft M.B.H.. 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 2020-03-31.
- Submission: K191860
- Applicant / Sponsor: Semperit Technische Produkte Gesellchaft M.B.H.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2020-03-31
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.