K191869

Substantially Equivalent

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

Applicant: Molnlycke Health Care Us, LLC
Product code: KGO
Advisory panel: General, Plastic Surgery
Date received: 2019-07-12
Decision date: 2020-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.