Cleared Traditional

K233560 - Powder Free Nitrile Examination Glove B...

K233560 is an FDA 510(k) clearance for Powder Free Nitrile Examination Glove B..., manufactured by Eco Medi Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K233560 · Eco Medi Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
112d
Days
Class 1
Risk

K233560 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Clai.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eco Medi Glove Sdn. Bhd. (Taiping, MY). The FDA issued a Cleared decision on February 26, 2024 after a review of 112 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 Eco Medi Glove Sdn. Bhd. devices

FDA 510(k) Submission Details - K233560

510(k) Number K233560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date February 26, 2024
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 K233560.
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
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
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · W.A. Rubbermate Co., Ltd. · Feb 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
K240072 · Luliang Hongruida Health Protection Technology 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