Cleared Special

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange (K220232) - FDA 510(k) Clearance

Class I General Hospital device.

K220232 · Megine Industries Sdn Bhd · General Hospital
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Feb 2022
Decision
24d
Days
Class 1
Risk

K220232 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Megine Industries Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on February 20, 2022 after a review of 24 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Megine Industries Sdn Bhd devices

Submission Details

510(k) Number K220232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2022
Decision Date February 20, 2022
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K220232.
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K212833 · Chifeng Huawei Medical Science&Technology Co., Ltd. · Feb 2022
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K213548 · Mercator Medical (Thailand), Ltd. · Feb 2022
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EONS Nitrile Examination Gloves Powder Free
K213286 · Eons Gloves (Thailand) Co., Ltd. · Feb 2022
Medical nitrile examination gloves (Model: SH001)
K213600 · Jiangxi Sanhao Medical Instruments Co.,Ltd · Feb 2022