Clearance Summary
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) received FDA 510(k) clearance under submission number K994131, sponsored by Medtaxx Partners. 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 2000-02-07.
- Submission: K994131
- Applicant / Sponsor: Medtaxx Partners
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-02-07
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.