Cleared Special

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K240072) - FDA 510(k) Clearance

Class I General Hospital device.

K240072 · Luliang Hongruida Health Protection Technology Co., Ltd. · General Hospital
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Feb 2024
Decision
30d
Days
Class 1
Risk

K240072 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use Wi.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Luliang Hongruida Health Protection Technology Co., Ltd. (Qujing, CN). The FDA issued a Cleared decision on February 9, 2024 after a review of 30 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 Luliang Hongruida Health Protection Technology Co., Ltd. devices

Submission Details

510(k) Number K240072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2024
Decision Date February 09, 2024
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 K240072.
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
K240051 · Lingshi Hongruida Health Protection Technology Co., Ltd. · Feb 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
K233560 · Eco Medi Glove Sdn. Bhd. · Feb 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · W.A. Rubbermate Co., Ltd. · Feb 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232764 · Eco Medi Glove Sdn. Bhd. · Feb 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
K233598 · Anhui Intco Medical Products Co., Ltd. · Jan 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
K233970 · Nephron Nitrile, LLC · Jan 2024