Cleared Special

Powder Free Nitrile Examination Gloves (Black) (K232353) - FDA 510(k) Clearance

Class I General Hospital device.

K232353 · Shanxi Hongjin Plastic Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
24d
Days
Class 1
Risk

K232353 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Black). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shanxi Hongjin Plastic Technology Co., Ltd. (Linfen, CN). The FDA issued a Cleared decision on August 31, 2023 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shanxi Hongjin Plastic Technology Co., Ltd. devices

Submission Details

510(k) Number K232353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2023
Decision Date August 31, 2023
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K232353.
Chemotherapy Gloves
K230847 · 3A Glove Sdn. Bhd. · Sep 2023
Powder-Free Nitrile Examination Gloves
K223214 · Global Protection Corp. · Sep 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K231643 · Syntex Healthcare Products Co., Ltd. · Sep 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K231435 · Kimberly Clark Corporation · Aug 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · Shandong Yinghng Medical Products Co., Ltd. · Aug 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · New Era Medicare Sdn. Bhd. · Aug 2023