Clearance Summary
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) received FDA 510(k) clearance under submission number K211310, sponsored by Megine Industries 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 2021-06-16.
- Submission: K211310
- Applicant / Sponsor: Megine Industries Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2021-06-16
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.