Clearance Summary
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove received FDA 510(k) clearance under submission number K231973, sponsored by Ineo Tech Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-09-29.
- Submission: K231973
- Applicant / Sponsor: Ineo Tech Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2023-09-29
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.