Clearance Summary
Vinyl patient examination glove, Powder Free received FDA 510(k) clearance under submission number K153159, sponsored by Xingyuan Plastic Products Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-01-26.
- Submission: K153159
- Applicant / Sponsor: Xingyuan Plastic Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2016-01-26
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.