Cleared Traditional

K191869 - 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 (FDA 510(k) Clearance)

Class I General Hospital device.

K191869 · Molnlycke Health Care Us, LLC · General Hospital

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Mar 2020

Decision

245d

Days

Class 1

Risk

K191869 is an FDA 510(k) clearance for the Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Clai.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on March 13, 2020 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Molnlycke Health Care Us, LLC devices

Submission Details

510(k) Number	K191869 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 12, 2019
Decision Date	March 13, 2020
Days to Decision	245 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

117d slower than avg

Panel avg: 128d · This submission: 245d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KGO Surgeon's Gloves
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 878.4460
Definition	A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.