Clearance Summary
Powder Free Vinyl Examination Gloves received FDA 510(k) clearance under submission number K211103, sponsored by Shanghai Shengda Medical Applications 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 2021-11-04.
- Submission: K211103
- Applicant / Sponsor: Shanghai Shengda Medical Applications Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-11-04
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.