Cleared Traditional

K211022 - Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. (FDA 510(k) Clearance)

Class I General Hospital device.

K211022 · Central Medicare Sdn Bhd · General Hospital

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Dec 2021

Decision

261d

Days

Class 1

Risk

K211022 is an FDA 510(k) clearance for the Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Central Medicare Sdn Bhd (Teluk Intan, MY). The FDA issued a Cleared decision on December 22, 2021 after a review of 261 days - an extended review cycle.

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.

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Submission Details

510(k) Number	K211022 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 05, 2021
Decision Date	December 22, 2021
Days to Decision	261 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

133d slower than avg

Panel avg: 128d · This submission: 261d

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.