Clearance Summary
Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein received FDA 510(k) clearance under submission number K190632, sponsored by Lenora Glove Pvt , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-10-24.
- Submission: K190632
- Applicant / Sponsor: Lenora Glove Pvt , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2019-10-24
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.