Clearance Summary
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE received FDA 510(k) clearance under submission number K993080, sponsored by Medtexx Partners, Inc.. 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 1999-10-20.
- Submission: K993080
- Applicant / Sponsor: Medtexx Partners, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1999-10-20
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.