Clearance Summary
Disposable Synthetic Examination Gloves received FDA 510(k) clearance under submission number K210520, sponsored by Shandong Shengshixincheng Medical Science & Technology Co.,. 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 2021-05-26.
- Submission: K210520
- Applicant / Sponsor: Shandong Shengshixincheng Medical Science & Technology Co.,
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-05-26
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.