FDA 510(k)

Stronghold Group Nitrile Examination Glove, Powder Free

Номер K: K213859 · 2022-01-13

Дата решения2022-01-13

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Stronghold Group Nitrile Examination Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Stronghold Group, LLC. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K213859. 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 Stronghold Group Nitrile Examination Glove, Powder Free?

Stronghold Group Nitrile Examination Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is Stronghold Group, LLC. The 510(k) number is K213859.

When did Stronghold Group Nitrile Examination Glove, Powder Free receive FDA 510(k) clearance?

Stronghold Group Nitrile Examination Glove, Powder Free received FDA 510(k) clearance on 2022-01-13, under 510(k) number K213859.

Who is the listed applicant for Stronghold Group Nitrile Examination Glove, Powder Free?

The FDA 510(k) record lists Stronghold Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stronghold Group Nitrile Examination Glove, Powder Free?

The FDA product code for Stronghold Group Nitrile Examination Glove, Powder Free 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.