Clearance Summary
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES received FDA 510(k) clearance under submission number K121811, sponsored by Shen Wei (Usa), Inc.. 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 2012-11-21.
- Submission: K121811
- Applicant / Sponsor: Shen Wei (Usa), Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2012-11-21
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.