Clearance Summary
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE received FDA 510(k) clearance under submission number K053259, sponsored by Practical Protective Plastic Manufactory , 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 2006-01-18.
- Submission: K053259
- Applicant / Sponsor: Practical Protective Plastic Manufactory , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2006-01-18
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.