Cleared Traditional

Disposable Nitrile Gloves (ABC-DG01) (K230542) - FDA 510(k) Clearance

Class I General Hospital device.

K230542 · Huizhou Anboson Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
92d
Days
Class 1
Risk

K230542 is an FDA 510(k) clearance for the Disposable Nitrile Gloves (ABC-DG01). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Huizhou Anboson Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on May 31, 2023 after a review of 92 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 Huizhou Anboson Technology Co., Ltd. devices

Submission Details

510(k) Number K230542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2023
Decision Date May 31, 2023
Days to Decision 92 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Ivy Wang

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 K230542.
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K230779 · Shanxi Hongjin Plastic Technology Co., Ltd. · Jun 2023
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K231349 · Nephron Nitrile, LLC · Jun 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633 · Dell Corning Corporation · Jun 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958 · First Glove Sdn. Bhd. · May 2023
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