Clearance Summary
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance under submission number K193555, sponsored by Ever Global (Vietnam) Enterprise Corp. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-06-04.
- Submission: K193555
- Applicant / Sponsor: Ever Global (Vietnam) Enterprise Corp
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-06-04
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.