Cleared Traditional

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

K191869 · Molnlycke Health Care Us, LLC · General Hospital
Mar 2020
Decision
245d
Days
Class 1
Risk

About This 510(k) Submission

K191869 is an FDA 510(k) clearance for the 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, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on March 13, 2020, 245 days after receiving the submission on July 12, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K191869 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KGO — Surgeon's Gloves
Device Class Class I — 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.

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