Fusion Black Powder-Free Nitrile Exam Glove— 510(k) K150113

Clearance details

Applicant

Halyard Health

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2015-01-20

Decision date

2015-06-18

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Roswell, GA, US

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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 →