FDA 510(k)

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

Номер K: K214056 · 2022-09-20

ЗаявительMezorrison Medical Technology (Dongying) Co., Ltd.

Дата решения2022-09-20

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Mezorrison Medical Technology (Dongying) Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K214056. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Mezorrison Medical Technology (Dongying) Co., Ltd.. The 510(k) number is K214056.

When did Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K214056.

Who is the listed applicant for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is LZA.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.