POWDER FREE NITRILE EXAMINATION GLOVES— 510(k) K110418

Substantially Equivalent

W.A. Rubbermate Co., Ltd.

FDA 510(k) clearance K110418 for POWDER FREE NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2011-07-13. Applicant: W.A. Rubbermate Co., Ltd.. Device class: 1.

Clearance details

Applicant
W.A. Rubbermate Co., Ltd.
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
A. Maung, Chonburi, TH
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZA

product code LZA
Other
1
Total
1

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

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