Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl— 510(k) K192954

Clearance details

Applicant

Comfort Rubber Gloves Industries Sdn. Bhd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2019-10-21

Decision date

2020-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Matang, 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 →