SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES— 510(k) K011717

Clearance details

Applicant

Sunmax Enterprise Shanghai Co. , Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2001-06-04

Decision date

2001-08-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Great Neck, NY, 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 →