Clearance Summary
Medical PVC Examination Gloves received FDA 510(k) clearance under submission number K210821, sponsored by Jiangxi Hongda Medical Equipment Group , 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 2021-07-09.
- Submission: K210821
- Applicant / Sponsor: Jiangxi Hongda Medical Equipment Group , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-07-09
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.