Cleared Traditional

Disposable Nitrile Examination Gloves (K203805) - FDA 510(k) Clearance

Class I General Hospital device.

K203805 · Jiangsu Yanfang Medical Technology Co., Ltd. · General Hospital
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Apr 2021
Decision
113d
Days
Class 1
Risk

K203805 is an FDA 510(k) clearance for the Disposable Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Yanfang Medical Technology Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on April 20, 2021 after a review of 113 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 Jiangsu Yanfang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K203805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date April 20, 2021
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 Truthful Information Technology Co., Ltd.
Boyle 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 K203805.
Disposable Nitrile Examination Gloves
K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021
Powder Free Blue Nitrile Examination Glove
K203512 · Vip Glove Sdn Bhd · Apr 2021
Nitrile Glove Powder Free Blue
K210145 · Changzhou Universal Medical Equipment Co., Ltd. · Apr 2021
BIOTECH Nitrile Examination Gloves
K202419 · Tk Hitech Technology Co., Ltd. · Apr 2021
Disposable Nitrile Gloves
K210276 · Fujian Ercon Medical Management Co., Ltd. · Apr 2021
Nitrile Examination Gloves
K210106 · Zhenjiang Huayang Latex Products Co., Ltd. · Apr 2021