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Maxter Sterile Powder Free Surgical Gloves

by Maxter Glove Manufacturing Sdn Bhd

510(k) K032501

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) K032501↗

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 NumberK032501 Date17 Oct 2003ClearedStatusActive
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  • Withdrawn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
KGO
Device Class
Class I
Regulation
21 CFR Part 878.4460
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 device is a Surgical Glove (FDA classification K032501), a sterile, single-use barrier designed to protect healthcare professionals and patients during surgical procedures. These gloves are powder-free, eliminating the risk of powder-related complications such as allergic reactions or contamination, while maintaining tactile sensitivity for precise surgical manipulation.

Supplied in sterile packaging, these gloves are intended for single-use in controlled environments such as operating rooms, minor surgical procedures, and other sterile medical settings. They comply with FDA 510(k) clearance (K032501) and EU MDR regulations, ensuring adherence to stringent safety and performance standards. Available in various sizes, they are stored under conditions that preserve sterility and integrity until use.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Are these gloves suitable for use in both major surgical procedures and minor medical examinations, and if so, why?

    Yes, these MAXTER STERILE POWDER FREE SURGICAL GLOVES are designed for controlled environments like operating rooms *and* minor surgical procedures. They are classified as Surgical Gloves (FDA K032501) and are sterile, single-use, and powder-free, which reduces contamination risks and allergic reactions. The powder-free formulation also maintains tactile sensitivity, making them suitable for precise manipulation in both high-stakes and routine medical settings.

  • How do I ensure the sterility of these gloves is maintained before use, and what storage conditions are recommended?

    The gloves are supplied in sterile packaging, so sterility is preserved as long as the packaging remains intact. They should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid placing them near chemicals or contaminated surfaces. Once opened, the gloves must be used immediately to prevent contamination.

  • What sizes are available for these gloves, and how do I determine the correct fit for my patients or myself?

    While the exact size range isn’t specified in the provided data, these gloves are available in various sizes to accommodate different hand measurements. For clinical use, refer to the manufacturer’s sizing chart (available on Maxter Glove Manufacturing Sdn Bhd’s documentation) or standard medical glove sizing guidelines. Proper fit ensures comfort, dexterity, and reduces the risk of glove tearing during procedures.

  • Why are these gloves labeled as powder-free, and what clinical benefits does that provide?

    These gloves are powder-free to eliminate risks associated with talc or cornstarch powder, such as allergic reactions, powder residue contamination, or adverse tissue reactions in patients. Powder-free gloves also reduce the risk of powder inhalation by healthcare workers, improving safety and compliance with modern medical standards. The formulation still ensures tactile sensitivity, which is critical for surgical precision.

  • What regulatory pathways have these gloves undergone, and how does that affect their use in clinical settings?

    These gloves have undergone FDA 510(k) clearance (K032501) and comply with EU MDR regulations, demonstrating adherence to stringent safety and performance standards. The FDA classification (K032501) confirms they meet requirements for surgical gloves, while the MDR compliance ensures they align with European medical device regulations. Clinicians can trust these gloves for sterile procedures, knowing they meet global regulatory benchmarks for quality and safety.