510(k) K193581— Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

Substantially Equivalent

Sri Trang Gloves (Thailand) Public Company Limited

Clearance details

Applicant: Sri Trang Gloves (Thailand) Public Company Limited
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2019-12-23
Decision date: 2020-03-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hatyai, TH

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.