K202090

Substantially Equivalent

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

Applicant: Molnlycke Health Care Us, LLC
Product code: KGO
Advisory panel: General, Plastic Surgery
Date received: 2020-07-28
Decision date: 2020-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peachtree Corners, GA, US

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