Clearance Summary
Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) received FDA 510(k) clearance under submission number K250578, sponsored by Careglove Global Sdn. Bhd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-04-01.
- Submission: K250578
- Applicant / Sponsor: Careglove Global Sdn. Bhd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2025-04-01
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.