Cleared Traditional

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

K202449 · Medline Industries, Inc. · General Hospital

Nov 2020

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K202449 is an FDA 510(k) clearance for the Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50?g/dm? 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 November 18, 2020, 84 days after receiving the submission on August 26, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K202449 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2020
Decision Date	November 18, 2020
Days to Decision	84 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.