Clearance Summary
POWDERED LATEX SURGEON'S GLOVE received FDA 510(k) clearance under submission number K121925, sponsored by Suzhou Colour-Way Enterprise Development Co., Ltd.. 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 2013-08-28.
- Submission: K121925
- Applicant / Sponsor: Suzhou Colour-Way Enterprise Development Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2013-08-28
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.