Cleared Traditional

Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50?g/dm2 per Glove of Extractable Protein

K202668 · Medline Industries, Inc. · General Hospital

Dec 2020

Decision

96d

Days

Class 1

Risk

About This 510(k) Submission

K202668 is an FDA 510(k) clearance for the Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50?g/dm2 per Glove of Extractable Protein, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on December 19, 2020, 96 days after receiving the submission on September 14, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K202668 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2020
Decision Date	December 19, 2020
Days to Decision	96 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.