Clearance Summary
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs received FDA 510(k) clearance under submission number K213289, sponsored by Ansell Healthcare Products, LLC. 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 2023-05-26.
- Submission: K213289
- Applicant / Sponsor: Ansell Healthcare Products, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2023-05-26
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.