Clearance Summary
Powder Free Yellow Vinyl Patient Examination Gloves received FDA 510(k) clearance under submission number K142508, sponsored by Zibo Huaqi Trading 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 2014-12-19.
- Submission: K142508
- Applicant / Sponsor: Zibo Huaqi Trading Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2014-12-19
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.