Cleared Traditional

Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

K202090 · Molnlycke Health Care Us, LLC · General Hospital

Nov 2020

Decision

117d

Days

Class 1

Risk

About This 510(k) Submission

K202090 is an FDA 510(k) clearance for the Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel 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 (Peachtree Corners, US). The FDA issued a Cleared decision on November 22, 2020, 117 days after receiving the submission on July 28, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K202090 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2020
Decision Date	November 22, 2020
Days to Decision	117 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.