FDA 510(k)

Donagamex Blue Performance Protective Gown

Номер K: K203821 · 2021-12-17

ЗаявительDong Nai Garment Corporation (Donagamex)

Дата решения2021-12-17

Код продуктаQPC

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Donagamex Blue Performance Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Dong Nai Garment Corporation (Donagamex). It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K203821. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Donagamex Blue Performance Protective Gown?

Donagamex Blue Performance Protective Gown is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Dong Nai Garment Corporation (Donagamex). The 510(k) number is K203821.

When did Donagamex Blue Performance Protective Gown receive FDA 510(k) clearance?

Donagamex Blue Performance Protective Gown received FDA 510(k) clearance on 2021-12-17, under 510(k) number K203821.

Who is the listed applicant for Donagamex Blue Performance Protective Gown?

The FDA 510(k) record lists Dong Nai Garment Corporation (Donagamex) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Donagamex Blue Performance Protective Gown?

The FDA product code for Donagamex Blue Performance Protective Gown is QPC.

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: QPC)

K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689AAMI Level 4 Защитная; халатAzac Group K233526Medline Open-back Level 3 Protective GownMedline Industries, LP K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.

Официальный источник

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