Clearance Summary
POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES received FDA 510(k) clearance under submission number K942149, sponsored by Ti-Mate Prophylactic Devices , Ltd.. 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 1994-10-13.
- Submission: K942149
- Applicant / Sponsor: Ti-Mate Prophylactic Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1994-10-13
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.