Clearance Summary
PROTEX (PATIENT EXAMINATION GLOVES) received FDA 510(k) clearance under submission number K892102, sponsored by Hon Shan Development , 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 1989-05-31.
- Submission: K892102
- Applicant / Sponsor: Hon Shan Development , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-05-31
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.