Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs— 510(k) K151390

Name: FDA 510(k) clearance K151390
Creator: U.S. Food and Drug Administration
Published: 2016-05-02

Substantially Equivalent

Maxter Glove Manufacturing Sdn Bhd

FDA 510(k) clearance K151390 for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs, Substantially Equivalent on 2016-05-02. Applicant: Maxter Glove Manufacturing Sdn Bhd. Device class: 1.

Clearance details

Applicant: Maxter Glove Manufacturing Sdn Bhd
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2015-05-26
Decision date: 2016-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, MY

Download summary PDF View on FDA.gov ↗

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K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs2022-05-26

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K172864 — Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs2018-05-02
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K040176 — MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES2004-02-24
K032501 — MAXTER STERILE POWDER FREE SURGICAL GLOVES2003-10-17
K032467 — MAXTER STERILE POWDERED LATEX SURGICAL GLOVES2003-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.