NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE— 510(k) K031580

Substantially Equivalent

Green Prospect Sdn Bhd

FDA 510(k) clearance K031580 for NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE, Substantially Equivalent on 2003-07-25. Applicant: Green Prospect Sdn Bhd. Device class: 1.

Clearance details

Applicant
Green Prospect Sdn Bhd
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
Sparks, NV, US
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.