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Blue Powder Free Latex Examination Gloves, Non-Sterile

by Multisafe Sdn. Bhd.

510(k) K062527

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) K062527↗

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 NumberK062527 Date20 Feb 2007ClearedStatusActive
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  • Withdrawn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
LYY
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Blue Powder Free Latex Examination Gloves, Non-Sterile are latex patient examination gloves. They are made of latex and are designed for use in medical settings, such as general hospitals. The gloves are powder free and have a smooth interior, which improves donning efficiency. They also have a textured surface, which delivers traction.

The gloves are supplied non-sterile and are intended for single-use. They are available in various sizes and are stored in a dry place. The gloves have been cleared by the FDA with a 510K number and have been classified as a Class 1 device. They comply with the Medical Device Regulation (MDR) and have been authorized with an FDA 510K clearance.

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Questions

AI-generated answers, 26 Sep 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 Blue Latex Exam Gloves used for?

    The gloves are designed for use in medical settings, such as general hospitals, for patient examination.

  • Are the gloves sterile?

    No, the gloves are supplied non-sterile.

  • Can the gloves be reused?

    No, the gloves are intended for single-use.

  • How should the gloves be stored?

    The gloves should be stored in a dry place.