Cleared Traditional

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

K230314 · New Era Medicare Sdn. Bhd. · General Hospital

Aug 2023

Decision

191d

Days

Class 1

Risk

About This 510(k) Submission

K230314 is an FDA 510(k) clearance for the Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by New Era Medicare Sdn. Bhd. (Teluk Intan, MY). The FDA issued a Cleared decision on August 16, 2023, 191 days after receiving the submission on February 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K230314 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2023
Decision Date	August 16, 2023
Days to Decision	191 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LZA — Polymer Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.