FDA 510(k)

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

K-Number: K190077 · 2019-05-24

Decision Date2019-05-24

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2019-05-24 under approval number K190077. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K190077.

When was Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove approved by the FDA?

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove received FDA 510(k) clearance on 2019-05-24, under approval number K190077.

What company makes Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is manufactured by Molnlycke Health Care Us, LLC.

What is the FDA product code for Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

The FDA product code for Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is KGO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.