Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)— 510(k) K211714

Substantially Equivalent

Hengchang (Dongying) Medical Technology Co., Ltd.

FDA 510(k) clearance K211714 for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy), Substantially Equivalent on 2021-08-04. Applicant: Hengchang (Dongying) Medical Technology Co., Ltd..

Clearance details

Applicant: Hengchang (Dongying) Medical Technology Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-06-03
Decision date: 2021-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongying, CN

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.