Clearance Summary
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim received FDA 510(k) clearance under submission number K191869, sponsored by Molnlycke Health Care Us, LLC. 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 2020-03-13.
- Submission: K191869
- Applicant / Sponsor: Molnlycke Health Care Us, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2020-03-13
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.