Cleared Special

K220541 - PureZero LIMON Nitrile Powder-Free Exam...

K220541 is the FDA 510(k) clearance for PureZero LIMON Nitrile Powder-Free Exam... by O&M Halyard, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Special 510(k) pathway after a 97-day FDA review.

K220541 · O&M Halyard, Inc. · General Hospital
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Jun 2022
Decision
97d
Days
Class 1
Risk

K220541 is an FDA 510(k) clearance for the PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile P.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 2, 2022 after a review of 97 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K220541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2022
Decision Date June 02, 2022
Days to Decision 97 days
Submission Type Special
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
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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 K220541.
Zoupure Nitrile Powder Free Examination glove
K220693 · Thai Rayong Product Glove Zoupure Co., Ltd. · Jun 2022
Powder Free Nitrile Gloves
K213448 · St Future International Limited · Jun 2022
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K220672 · Riverstone Resources Sdn Bhd · Jun 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
K220547 · O&M Halyard, Inc. · Jun 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Jun 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699 · Mastermax Plastic (Huizhou), Ltd. · May 2022