Clearance Summary
POWDERFREE NITRILE PATIENT EXMINATION GLOVE received FDA 510(k) clearance under submission number K003985, sponsored by Guthrie Medicare Products (Melaka) 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 2001-02-09.
- Submission: K003985
- Applicant / Sponsor: Guthrie Medicare Products (Melaka) Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-02-09
Classification & Regulation
This clearance is catalogued under FDA product code LZA and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.