FDA 510(k)

Powder Free Nitrile Examination Gloves (White, Blue and Black)

Номер K: K212998 · 2022-02-19

Дата решения2022-02-19

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Powder Free Nitrile Examination Gloves (White, Blue and Black) is the device name listed in this FDA 510(k) record. The listed applicant is Alcatron Gloves Factory. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212998. 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 Powder Free Nitrile Examination Gloves (White, Blue and Black)?

Powder Free Nitrile Examination Gloves (White, Blue and Black) is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Alcatron Gloves Factory. The 510(k) number is K212998.

When did Powder Free Nitrile Examination Gloves (White, Blue and Black) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (White, Blue and Black) received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212998.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (White, Blue and Black)?

The FDA 510(k) record lists Alcatron Gloves Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black)?

The FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black) 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.

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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

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