Name: Predicase
Price: 199 USD

K-number	K202090
Device name	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
Device class	Class I
Decision date	Nov 22, 2020
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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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

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