Clearance Summary
PRE-POWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance under submission number K974442, sponsored by P.T. Latexindo Tobaperkasa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-01-05.
- Submission: K974442
- Applicant / Sponsor: P.T. Latexindo Tobaperkasa
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1998-01-05
Classification & Regulation
This clearance is catalogued under FDA product code LZY and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.