FDA 510(k)

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

Номер K: K212532 · 2021-11-11

ЗаявительCrdlight Optoelectronic Technology Co., Ltd.

Дата решения2021-11-11

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Crdlight Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-11 under 510(k) number K212532. 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 Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-11-11. The listed applicant is Crdlight Optoelectronic Technology Co., Ltd.. The 510(k) number is K212532.

When did Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) received FDA 510(k) clearance on 2021-11-11, under 510(k) number K212532.

Who is the listed applicant for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

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

What is the FDA product code for Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)?

The FDA product code for Disposable Powder Free Nitrile Exam 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.