FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Номер K: K211667 · 2021-09-23

ЗаявительChangzhou Universal Medical Equipment Co., Ltd.

Дата решения2021-09-23

Код продуктаLAZ

Консультативный комитетTX

РешениеSubstantially Equivalent

Описание устройства

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211667. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K211667.

When did Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211667.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA 510(k) record lists Changzhou Universal Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is LAZ.

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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Другие записи, где Changzhou Universal Medical Equipment Co., Ltd. указан как заявитель

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Официальный источник

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