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Nitrile Exam Glove, Extended Cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

by Zhonghong Pulin Medical Products Co., Ltd.

510(k) K230662

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) K230662↗

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 NumberK230662 Date26 Oct 2023ClearedStatusActive
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  • Withdrawn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
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Nitrile Exam Glove is a disposable device worn on the examiner's hand to prevent contamination between patient and examiner. It is made of nitrile and features an extended cuff. The glove has been tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs. It is intended for medical purposes. The device is a type of patient examination glove.

The Nitrile Exam Glove is supplied as a non-sterile, single-use device. It is available with an extended cuff for added protection. The device has received FDA 510K and MDR authorizations. The glove is made by Zhonghong Pulin Medical Products Co., Ltd. and has a product code of LZA.

Other devices from Zhonghong Pulin Medical Products Co., Ltd.

Questions

AI-generated answers, 21 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 is the Nitrile Exam Glove used for?

    The Nitrile Exam Glove is used to prevent contamination between patient and examiner during medical procedures, and has been tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs.

  • Is the Nitrile Exam Glove sterile?

    The Nitrile Exam Glove is supplied as a non-sterile device, intended for single-use.

  • What are the key features of the Nitrile Exam Glove?

    The glove is made of nitrile, features an extended cuff for added protection, and has received FDA 510K and MDR authorizations.

  • How is the Nitrile Exam Glove supplied?

    The Nitrile Exam Glove is supplied as a single-use device, available with an extended cuff for added protection.