Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)— 510(k) K211608

Clearance details

Applicant

Jiangsu Cureguard Glove Co., Ltd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2021-05-25

Decision date

2021-08-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suqian, CN

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• K210691 — Disposable Nitrile Medical Examination Glove2021-07-30
• K210684 — Disposable Nitrile Medical Examination Glove2021-07-20

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 →