Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)— 510(k) K212408

Clearance details

Applicant

Pt. Maja Agung Latexindo

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2021-08-03

Decision date

2022-05-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunggal, Deli Serdang, ID

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• K020040 — LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM2002-08-01
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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 →