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— 510(k) K202090
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K202090 for 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, Substantially Equivalent on 2020-11-22. Applicant: Molnlycke Health Care Us, LLC.
Clearance details
- Applicant
- Molnlycke Health Care Us, LLC
- Product code
- Code KGO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Peachtree Corners, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.