Clearance Summary
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) received FDA 510(k) clearance under submission number K160928, sponsored by Hartalega Sdb. Bhd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2016-12-20.
- Submission: K160928
- Applicant / Sponsor: Hartalega Sdb. Bhd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2016-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.