Zhonghong Pulin Medical Products Co.,Ltd.
Tangshan Hebei, CN
ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. appears in FDA device records in Tangshan Hebei, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Zhonghong Pulin Medical Products Co.,Ltd. between 2016 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | LZA | Substantially Equivalent | |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | LZA | Substantially Equivalent | |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | LYZ | Substantially Equivalent | |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010201834 | 3010201834 | ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. | West Industrial Park, BDA, Luannan County, Tangshan Hebei 063500 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain