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Nitrile Examination Gloves (Model ZMG1351)

by Wuhan Zonsen Medical Products Co., Ltd

510(k) K213688

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213688↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213688 Date18 Feb 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LZA
FDA applicant
Wuhan Zonsen Medical Products Co., Ltd.
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nitrile Examination Gloves (Model ZMG1351) are a type of non-powdered patient examination glove, classified under product code LZA. These gloves are designed to provide a barrier between healthcare professionals and patients during clinical examinations, reducing the risk of cross-contamination and infection. Constructed from nitrile, they offer enhanced chemical resistance and durability compared to latex or vinyl alternatives. Their design adheres to regulatory standards for patient safety and procedural hygiene.

These gloves are intended for single-use in clinical settings, including general hospitals, and are supplied sterile to ensure optimal protection. The device is authorized under FDA 510(k) clearance (K213688) and the EU Medical Device Regulation (MDR). No third-party certification is required for distribution. Storage should follow manufacturer guidelines to maintain sterility and integrity until use, with no specific MRI safety considerations noted.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the ZMG1351 nitrile examination gloves designed for?

    The ZMG1351 nitrile examination gloves are specifically designed to act as a protective barrier between healthcare professionals and patients during clinical examinations. Their primary purpose is to reduce the risk of cross-contamination and infection transmission, ensuring procedural hygiene in settings like general hospitals. The nitrile material also provides superior chemical resistance and durability compared to latex or vinyl gloves, making them ideal for tasks requiring extra protection.

  • Are the ZMG1351 nitrile examination gloves sterile and single-use?

    Yes, the ZMG1351 nitrile examination gloves are supplied sterile to ensure maximum protection against pathogens during use. They are intended for single-use only, adhering to best practices in infection control to prevent contamination between patients or procedures. This design minimizes the risk of microbial transmission and ensures compliance with regulatory standards for patient safety.

  • What regulatory approvals do the ZMG1351 nitrile examination gloves hold?

    The ZMG1351 nitrile examination gloves are authorized under the FDA’s 510(k) clearance process (K213688) and comply with the EU Medical Device Regulation (MDR). These approvals confirm that the gloves meet stringent safety and performance requirements for use in clinical settings. No additional third-party certification is required for distribution, simplifying procurement for healthcare providers.

  • How should the ZMG1351 nitrile examination gloves be stored to maintain sterility?

    To preserve sterility and integrity, the ZMG1351 nitrile examination gloves should be stored according to the manufacturer’s guidelines. This typically involves keeping them in their original, sealed packaging away from direct sunlight, extreme temperatures, and sources of contamination. Proper storage ensures the gloves remain effective for their intended single-use application and prevents compromise of their protective properties.

  • Are there any special considerations for using the ZMG1351 gloves in MRI environments?

    The manufacturer does not specify any special MRI safety considerations for the ZMG1351 nitrile examination gloves. However, as with all medical devices, it is advisable to verify compatibility with MRI equipment and protocols in your facility before use. If there are concerns about magnetic interference or material safety, consult the device’s technical documentation or your facility’s MRI safety guidelines.