Examination gloves -Type C (Nitrile gloves)— 510(k) K212290

Substantially Equivalent

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

FDA 510(k) clearance K212290 for Examination gloves -Type C (Nitrile gloves), Substantially Equivalent on 2021-10-28. Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd..

Clearance details

Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-07-21
Decision date: 2021-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanchang, 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.