Cleared Traditional

Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K234097) - FDA 510(k) Clearance

Class I General Hospital device.

K234097 · Ever Growth (Vietnam) Corporation Limited · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
92d
Days
Class 1
Risk

K234097 is an FDA 510(k) clearance for the Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ever Growth (Vietnam) Corporation Limited (Long Khanh City, VN). The FDA issued a Cleared decision on March 27, 2024 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ever Growth (Vietnam) Corporation Limited devices

Submission Details

510(k) Number K234097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2023
Decision Date March 27, 2024
Days to Decision 92 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

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 K234097.
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Apr 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K240080 · Syntex Healthcare Products Co., Ltd. · Apr 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
K233990 · Shandong Xingyu Gloves Co., Ltd. · Apr 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
K231938 · O&M Halyard, Inc. · Mar 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
K232654 · Nephron Nitrile, LLC · Mar 2024
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
K231365 · Anhui Intco Medical Products Co., Ltd. · Mar 2024