Cleared Traditional

Medical Nitrile Examination Gloves (Power free, Blue) (K210578) - FDA 510(k) Clearance

Class I General Hospital device.

K210578 · Jiangxi Hongda Medical Equipment Group , Ltd. · General Hospital
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Jul 2021
Decision
134d
Days
Class 1
Risk

K210578 is an FDA 510(k) clearance for the Medical Nitrile Examination Gloves (Power free, Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangxi Hongda Medical Equipment Group , Ltd. (Nanchang, CN). The FDA issued a Cleared decision on July 10, 2021 after a review of 134 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 Jiangxi Hongda Medical Equipment Group , Ltd. devices

Submission Details

510(k) Number K210578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2021
Decision Date July 10, 2021
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray 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 K210578.
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547 · Edma Group, LLC · Jul 2021
Nitrile Patient Examination Glove
K210723 · Jiangxi Zhonghong Pulin Medical Products Co., Ltd. · Jul 2021
Nitrile Examination Gloves
K210776 · 5r Med Instruments (Chengdu) Co., Ltd. · Jul 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587 · Onetexx Sdn Bhd · Jun 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K210775 · Onetexx Sdn Bhd · Jun 2021
Nitrile Glove
K211252 · Jiangsu Dihong Industry and Trade Co., Ltd. · Jun 2021