PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs— 510(k) K183280

Clearance details

Applicant

Smart Glove Corporation Sdn. Bhd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2018-11-23

Decision date

2019-07-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Klang, MY

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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 →