Clearance Summary
Betel Gloves Nitrile Examination Glove Powder Free received FDA 510(k) clearance under submission number K222342, sponsored by Betel Care 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 2022-09-24.
- Submission: K222342
- Applicant / Sponsor: Betel Care Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2022-09-24
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.