Cleared Traditional

K211390 - Nitrile Blue Powder-free Examination Glove

K211390 is an FDA 510(k) clearance for Nitrile Blue Powder-free Examination Glove, manufactured by Cardinal Health200, LLC. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K211390 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
115d
Days
Class 1
Risk

K211390 is an FDA 510(k) clearance for the Nitrile Blue Powder-free Examination Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on August 28, 2021 after a review of 115 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 Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K211390

510(k) Number K211390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2021
Decision Date August 28, 2021
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
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 1035
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211390.
Nitrile Examination Gloves Powder Free (Blue)
K210868 · Great Eco Glove Sdn. Bhd. · Sep 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778 · Zhenjiang Suhui Latex Products Co., Ltd. · Sep 2021
Disposable Medical Nitrile Gloves
K211673 · Changzhou Yihua Sanitation Material Co., Ltd. · Sep 2021
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
K210898 · Tangshan Lanhai Medical Supplies Co., Ltd. · Aug 2021
Disposable Nitrile Examination Gloves
K210897 · Shandong DS Safety Technology Co., Ltd. · Aug 2021
Nitrile Examination Gloves
K211515 · Beijing Reagent Latex Products Co., Ltd. · Aug 2021