Clearance Summary
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim received FDA 510(k) clearance under submission number K191800, sponsored by Kossan International 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 2019-09-16.
- Submission: K191800
- Applicant / Sponsor: Kossan International Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2019-09-16
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.