Cleared Special

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K222714) - FDA 510(k) Clearance

Class I General Hospital device.

K222714 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
29d
Days
Class 1
Risk

K222714 is an FDA 510(k) clearance for the Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drug.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on October 7, 2022 after a review of 29 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 Guangdong Kingfa Sci. & Tech.Co., Ltd. devices

Submission Details

510(k) Number K222714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2022
Decision Date October 07, 2022
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K222714.
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
K222298 · Onetexx Sdn Bhd · Oct 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K222721 · Safeskin Retailing (Hk) Limited · Oct 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
K222074 · Zibo Langu New Material Technology Co., Ltd. · Oct 2022
Disposable Nitrile Examination Glove
K222937 · Jiangsu Cureguard Glove Co., Ltd. · Oct 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
K221378 · Tec Gloves Industry (M) Sdn.Bhd. · Sep 2022
Powder Free Nitrile Examination Glove
K212751 · Dainam Glove Joint Stock Company · Sep 2022