Clearance Summary
PB PLUS LEAD LATEX GLOVES received FDA 510(k) clearance under submission number K896759, sponsored by Sistem Med-Pro (M) Sdn Bhd. 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 1990-03-27.
- Submission: K896759
- Applicant / Sponsor: Sistem Med-Pro (M) Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1990-03-27
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.