FDA 510(k)

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

Номер K: K211209 · 2021-12-17

Дата решения2021-12-17

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hycare International Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K211209. 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 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Hycare International Co., Ltd.. The 510(k) number is K211209.

When did Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves receive FDA 510(k) clearance?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211209.

Who is the listed applicant for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

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

What is the FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves 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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