Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color— 510(k) K190860

Clearance details

Applicant

Ever Growth (Vietnam) Co. , Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2019-04-02

Decision date

2019-12-23

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Binhloc Village, VN

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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 →