Clearance Summary
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE received FDA 510(k) clearance under submission number K132354, sponsored by Advanced Health Products, Lot 60 & 61. 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 2014-06-30.
- Submission: K132354
- Applicant / Sponsor: Advanced Health Products, Lot 60 & 61
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2014-06-30
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.