Clearance Summary
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) received FDA 510(k) clearance under submission number K010863, sponsored by La Glove (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 2001-05-03.
- Submission: K010863
- Applicant / Sponsor: La Glove (M) Sdn. Bhd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2001-05-03
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.