Clearance Summary
Blue Latex Examination Powder Free Gloves received FDA 510(k) clearance under submission number K192329, sponsored by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-11-25.
- Submission: K192329
- Applicant / Sponsor: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2019-11-25
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.