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— 510(k) K191869
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K191869 for 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, Substantially Equivalent on 2020-03-13. 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
- Norcross, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.