Biogel (R) Indicator (R) Underglove

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K111413 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Avance Gauze Dressing Kits

  Class II

  FDA 510(k) K161948 Active Cleared 3 Nov 2016

• Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

  Class I

  FDA 510(k) K193573 Active Cleared 10 Apr 2020

• Biogel Orthopor Brown Surgical Glove

  Class I

  FDA 510(k) K112089 Active Cleared 24 Aug 2011

• Exufiber Ag+

  Unclassified

  FDA 510(k) K160379 Active Cleared 25 Aug 2016

• 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

  Class I

  FDA 510(k) K191869 Active Cleared 13 Mar 2020

• Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement

  Class I

  FDA 510(k) K071700 Active Cleared 11 Sep 2007

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