Clearance Summary
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES received FDA 510(k) clearance under submission number K001601, sponsored by Shanghai PT Plastics Enterprise Company, 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 2000-06-23.
- Submission: K001601
- Applicant / Sponsor: Shanghai PT Plastics Enterprise Company, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-06-23
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.