Cleared Traditional

K234097 - Disposable Powder Free Nitrile Examinat...

K234097 is an FDA 510(k) clearance for Disposable Powder Free Nitrile Examinat..., manufactured by Ever Growth (Vietnam) Corporation Limited. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K234097 · Ever Growth (Vietnam) Corporation Limited · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K234097

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.

LZA Device Classification - Class 1, General Controls

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 682
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