Cleared Traditional

K211390 - Nitrile Blue Powder-free Examination Glove

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

K211390 · Cardinal Health200, LLC · General Hospital
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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

Submission Details

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.

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 583
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