Clearance Summary
Sterile Polyisoprene Powder Free Surgical Gloves received FDA 510(k) clearance under submission number K171047, sponsored by Better Care Plastic Technology Co., 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 2017-06-22.
- Submission: K171047
- Applicant / Sponsor: Better Care Plastic Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2017-06-22
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.