Cleared Traditional

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

K190077 · Molnlycke Health Care Us, LLC · General Hospital
May 2019
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K190077 is an FDA 510(k) clearance for the Biogel? PI UltraTouch S Surgical Glove, Biogel? Pl Ultra Touch S Indicator Underglove, 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 May 24, 2019, 128 days after receiving the submission on January 16, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K190077 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2019
Decision Date May 24, 2019
Days to Decision 128 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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