510(k) K202090
K202090 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care Us, LLC for the device "Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim". The FDA issued a decision of Substantially Equivalent on November 22, 2020. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Molnlycke Health Care Us, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2020
- Date Received
- July 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgeon'S Gloves
- Device Class
- Class I
- Regulation Number
- 878.4460
- Review Panel
- HO
- Submission Type
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.