Clearance Summary
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance under submission number K151390, sponsored by Maxter Glove Manufacturing Sdn Bhd. 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 2016-05-02.
- Submission: K151390
- Applicant / Sponsor: Maxter Glove Manufacturing Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2016-05-02
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.