Cleared Traditional

K200072 - KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (FDA 510(k) Clearance)

Class I General Hospital device.

K200072 · Kimberly Clark Corporation · General Hospital

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Apr 2020

Decision

87d

Days

Class 1

Risk

K200072 is an FDA 510(k) clearance for the KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Che.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kimberly Clark Corporation (Roswell, US). The FDA issued a Cleared decision on April 10, 2020 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kimberly Clark Corporation devices

Submission Details

510(k) Number	K200072 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 14, 2020
Decision Date	April 10, 2020
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

41d faster than avg

Panel avg: 128d · This submission: 87d

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.