NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE— 510(k) K100979

Substantially Equivalent

Jiangsu Sunshine Plastic Products, Co., Ltd.

FDA 510(k) clearance K100979 for NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE, Substantially Equivalent on 2010-07-02. Applicant: Jiangsu Sunshine Plastic Products, Co., Ltd.. Device class: 1.

Clearance details

Applicant
Jiangsu Sunshine Plastic Products, 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
Taipei County, TW
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 →

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