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Yanbian Pacific Textile Co., Ltd.

ChinaFDA 510(k) applicant, unverified

Devices
1

What Yanbian Pacific Textile Co., Ltd. makes

Yanbian Pacific Textile Co., Ltd. manufactures surgical isolation gowns designed for single-use in medical settings to protect healthcare workers and patients from contamination during procedures.

The company’s surgical isolation gowns are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Surgical Isolation Gown Ref K203415

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Yanbian Pacific Textile Co., Ltd. have in the registry?

The registry currently lists 1 device for Yanbian Pacific Textile Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Yanbian Pacific Textile Co., Ltd.'s devices?

Among its 1 most recently registered device, Yanbian Pacific Textile Co., Ltd. has devices listed in FDA 510(k) (1 device).

What risk classes do Yanbian Pacific Textile Co., Ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Yanbian Pacific Textile Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Yanbian Pacific Textile Co., Ltd. in the registry?

The most recently registered devices listed for Yanbian Pacific Textile Co., Ltd. include Surgical Isolation Gown.

Generated automatically from registry data and not verified by a human reviewer.