Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs— 510(k) K152542

Clearance details

Applicant

Riverstone Resources Sdn Bhd

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2015-09-04

Decision date

2015-12-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bukit Beruntung, 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 →