Clearance Summary
Sterile Nitrile Surgical Gloves Powder Free received FDA 510(k) clearance under submission number K222350, sponsored by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-04-13.
- Submission: K222350
- Applicant / Sponsor: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2023-04-13
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.