FDA 510(k)

NBR Synthetic Nitrile Examination Gloves

Номер K: K212436 · 2021-12-23

ЗаявительShandong Langtai International Trade Co., Ltd.

Дата решения2021-12-23

Код продуктаLYZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

NBR Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Langtai International Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K212436. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the NBR Synthetic Nitrile Examination Gloves?

NBR Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Shandong Langtai International Trade Co., Ltd.. The 510(k) number is K212436.

When did NBR Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

NBR Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-12-23, under 510(k) number K212436.

Who is the listed applicant for NBR Synthetic Nitrile Examination Gloves?

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

What is the FDA product code for NBR Synthetic Nitrile Examination Gloves?

The FDA product code for NBR Synthetic Nitrile Examination Gloves is LYZ.

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: LYZ)

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Официальный источник

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