Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs— 510(k) K182308

Substantially Equivalent

Sri Trang Gloves (Thailand) Co., Ltd.

FDA 510(k) clearance K182308 for Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs, Substantially Equivalent on 2019-05-30. Applicant: Sri Trang Gloves (Thailand) Co., Ltd..

Clearance details

Applicant: Sri Trang Gloves (Thailand) Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2018-08-24
Decision date: 2019-05-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hatyai, TH

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZA

product code LZA

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.