Clearance Summary
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance under submission number K200539, sponsored by Sri Trang Gloves (Thailand) Public Company Limited. 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 2020-04-09.
- Submission: K200539
- Applicant / Sponsor: Sri Trang Gloves (Thailand) Public Company Limited
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2020-04-09
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.