DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS— 510(k) K110979

Name: FDA 510(k) clearance K110979
Creator: U.S. Food and Drug Administration
Published: 2011-10-20

Substantially Equivalent

Advanced Medical Products Sdn Bhd

FDA 510(k) clearance K110979 for DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS, Substantially Equivalent on 2011-10-20. Applicant: Advanced Medical Products Sdn Bhd. Device class: 1.

Clearance details

Applicant: Advanced Medical Products Sdn Bhd
Product code: Code LZA
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2011-04-07
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer Tawar, MY

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZA

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Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K110979

K-number listed on FDA's recall record

Z-0133-2016 — Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.Class II·Terminated·Cardinal Health·20150825

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110979.

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