Cleared Traditional

Sterile Surgical Powder Free Latex Glove

K221424 · New Era Medicare Sdn. Bhd. · General Hospital

Jan 2023

Decision

255d

Days

Class 1

Risk

About This 510(k) Submission

K221424 is an FDA 510(k) clearance for the Sterile Surgical Powder Free Latex Glove, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by New Era Medicare Sdn. Bhd. (Teluk Intan, MY). The FDA issued a Cleared decision on January 26, 2023, 255 days after receiving the submission on May 16, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K221424 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2022
Decision Date	January 26, 2023
Days to Decision	255 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.