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FDA 510(k)

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

Número K: K231029 · 2023-10-30

RequerenteZhonghong Pulin Medical Products Co., Ltd.
Data da decisão2023-10-30
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K231029. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl?

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K231029.

When did Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl receive FDA 510(k) clearance?

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl received FDA 510(k) clearance on 2023-10-30, under 510(k) number K231029.

Who is the listed applicant for Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl?

The FDA 510(k) record lists Zhonghong Pulin Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl?

The FDA product code for Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl is LZA.

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Outros registros que listam Zhonghong Pulin Medical Products Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other DrugsK210460NitriTec Vinyl Glove Powder Free BlueK171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsK152712Nitrile Powder Free Patient Examination Gloves, Blue Color

Dispositivos Relacionados (Código: LZA)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fonte oficial

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