Clearance Summary
Disposable Vinyl Nitrile Synthetic Gloves Powder Free received FDA 510(k) clearance under submission number K211516, sponsored by Tangshan Hongyun 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 2021-08-24.
- Submission: K211516
- Applicant / Sponsor: Tangshan Hongyun Plastic Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-08-24
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.