Clearance Summary
NATURAL-TOUCH (TM) SURGEON'S GLOVE received FDA 510(k) clearance under submission number K872996, sponsored by Hands-On Packaging , Ltd.. 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 1988-03-04.
- Submission: K872996
- Applicant / Sponsor: Hands-On Packaging , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1988-03-04
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.