Cleared Traditional

Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075) - FDA 510(k) Clearance

Class I General Hospital device.

K211075 · Jiangsu Cherish Medical Technology Co., Ltd. · General Hospital
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Aug 2021
Decision
115d
Days
Class 1
Risk

K211075 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves (Non-Sterile). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Cherish Medical Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 5, 2021 after a review of 115 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 Cherish Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K211075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date August 05, 2021
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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

Cnmed Consultant
Johnson Liu

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 K211075.
Nitrile Patient Examination Glove
K210730 · American Performance Polymers, LLC · Aug 2021
Edma Synthetic Nitrile Examination Gloves
K211540 · Edma Group, LLC · Aug 2021
Nitrile Patient Examination Glove
K210725 · Pingan Medical Products Co., Ltd. · Aug 2021
Nitrile Patient Examination Gloves
K211434 · Zhangjiagang Huayuan Protective Equipment Co., Ltd. · Aug 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
K211608 · Jiangsu Cureguard Glove Co., Ltd. · Aug 2021
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
K211714 · Hengchang (Dongying) Medical Technology Co., Ltd. · Aug 2021