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Powder Free Blue Nitrile Examination Glove

by Qube Medical Product Sdn Bhd

510(k) K153732

Active European Union and United States

CE MDD 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) K153732↗

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 NumberK153732 Date29 Jul 2016ClearedStatusActive
European UnionCE/MDD 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  • Withdrawn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/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LZA
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 Powder-Free Blue Nitrile Examination Glove is a single-use, powder-free barrier device classified as a glove, examination (FDA Product Code: LZA). Constructed from synthetic nitrile rubber, it provides a latex-free alternative for medical examinations, ensuring protection against latex sensitivity while maintaining resistance to oils, greases, and certain chemicals. Its design eliminates powder, reducing the risk of contamination or allergic reactions during use. The device adheres to FDA 510(k) clearance and MDD compliance, confirming its suitability for clinical and procedural applications requiring sterile protection.

Supplied in packs of 100 or 200 pieces, the gloves are available in sizes Small, Medium, Large, and Extra Large, catering to diverse user requirements. They are intended for single-use only and must be discarded after use to prevent cross-contamination. The device is non-sterile as supplied, requiring terminal sterilization or cleaning if reused (though single-use is recommended). No MRI safety information is specified, and storage should follow manufacturer guidelines to maintain integrity. Authorizations include FDA 510(k) clearance (K153732) and MDD compliance, ensuring regulatory adherence for medical and industrial applications.

Other devices from Qube Medical Product Sdn Bhd

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 Powder-Free Blue Nitrile Examination Glove used for?

    This glove is designed as a single-use barrier device for medical examinations, providing protection against latex sensitivity while maintaining resistance to oils, greases, and certain chemicals. Its powder-free construction reduces contamination risks, making it suitable for clinical and procedural applications requiring sterile protection.

  • How is the Powder-Free Blue Nitrile Examination Glove supplied?

    The gloves are supplied in packs containing either 100 or 200 pieces. They come in four sizes—Small, Medium, Large, and Extra Large—to accommodate different user requirements.

  • Is the Powder-Free Blue Nitrile Examination Glove sterile as supplied?

    No, the gloves are non-sterile as supplied. If reused (though single-use is recommended), they must undergo terminal sterilization or cleaning before use to ensure safety and sterility.

  • Can the Powder-Free Blue Nitrile Examination Glove be reused?

    The device is intended for single-use only. Reuse is not recommended to prevent cross-contamination, but if reused, it must be terminally sterilized or cleaned first.

  • What storage guidelines should be followed for the Powder-Free Blue Nitrile Examination Glove?

    Storage should follow the manufacturer’s guidelines to maintain the glove’s integrity. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these conditions may compromise the material’s performance.