Clearance Summary
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue received FDA 510(k) clearance under submission number K153028, sponsored by Zibo Huiying Medical 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 2016-02-05.
- Submission: K153028
- Applicant / Sponsor: Zibo Huiying Medical Products, Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2016-02-05
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.