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Single-Use Medical Poly(Vinyl Chloride) Examination Glove (Clear, Non-Colored)

by Hebei Titans Hongsen Medical Technology Co.，Ltd

510(k) K182043

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) K182043↗

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 NumberK182043 Date21 Sep 2018ClearedStatusActive
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  • Withdrawn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
LYZ
FDA applicant
Hebei Titans Hongsen Medical Technology 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.

This device is a single-use medical vinyl patient examination glove, classified under FDA regulation 880.6250. It is designed as a disposable barrier worn on the examiner’s hands to prevent cross-contamination between patient and user during medical examinations. Constructed from poly(vinyl chloride), the glove is intended for general hospital use and provides a clear, non-colored barrier for tactile sensitivity and visibility of hand movements.

The gloves are supplied as sterile, single-use items and must be discarded after each procedure to maintain infection control. They are compatible with standard medical imaging environments, including MRI settings, as they do not contain metallic or ferromagnetic components. Available in various sizes, they are packaged individually for immediate use and require no additional preparation. Authorized under FDA 510(k) clearance (K182043) and MDR compliance, these gloves adhere to regulatory standards for medical examination wear.

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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 is the clear vinyl examination glove designed for?

    This single-use vinyl glove is designed as a disposable barrier to prevent cross-contamination between patients and healthcare providers during medical examinations. Its clear, non-colored material ensures tactile sensitivity and visibility of hand movements, making it ideal for general hospital use.

  • How are these gloves supplied, and do they require preparation?

    The gloves are supplied sterile, individually packaged, and ready for immediate use. No additional preparation is needed before donning them, ensuring convenience and maintaining infection control standards.

  • Are these gloves safe for use in MRI environments?

    Yes, these gloves are MRI-compatible because they do not contain metallic or ferromagnetic components. This makes them suitable for use in standard medical imaging environments, including MRI settings.

  • What sizes are available for these examination gloves?

    The gloves are available in multiple sizes to accommodate different hand measurements. The exact sizing options are listed in the provided registration numbers (e.g., 3002166545, 3005558160), which correspond to standard vinyl glove sizes.

  • How should these gloves be stored, and what is their shelf life?

    These gloves should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Since they are single-use and sterile, they should be used immediately after opening the package. The manufacturer’s packaging typically includes expiration dates, which should be respected.