Cleared Traditional

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

K243959 · Lingshi Hongruida Health Protection Technology Co., Ltd. · General Hospital

Feb 2025

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K243959 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Lingshi Hongruida Health Protection Technology Co., Ltd. (Jinzhong, CN). The FDA issued a Cleared decision on February 24, 2025, 63 days after receiving the submission on December 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K243959 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	February 24, 2025
Days to Decision	63 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LZC — Medical Glove, Specialty
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.