Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs— 510(k) K230662

Clearance details

Applicant

Zhonghong Pulin Medical Products Co., Ltd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2023-03-10

Decision date

2023-10-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tangshan, CN

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• K231029 — Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl2023-10-30
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• K171873 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs2017-11-15
• K152712 — Nitrile Powder Free Patient Examination Gloves, Blue Color2016-03-09

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 →