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FDA 510(k)

Plus Medical Chemotherapy Gown

K-Number: K211036 · 2022-05-04

ApplicantFoshan Nanhai Plus Medical Co, Ltd.
Decision Date2022-05-04
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plus Medical Chemotherapy Gown is a medical device manufactured by Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-05-04 under approval number K211036. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plus Medical Chemotherapy Gown?

Plus Medical Chemotherapy Gown is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K211036.

When was Plus Medical Chemotherapy Gown approved by the FDA?

Plus Medical Chemotherapy Gown received FDA 510(k) clearance on 2022-05-04, under approval number K211036.

What company makes Plus Medical Chemotherapy Gown?

Plus Medical Chemotherapy Gown is manufactured by Foshan Nanhai Plus Medical Co, Ltd..

What is the FDA product code for Plus Medical Chemotherapy Gown?

The FDA product code for Plus Medical Chemotherapy Gown is FYA.

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Related PubMed Literature

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Other Devices by Foshan Nanhai Plus Medical Co, Ltd.

K210143Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) K213177Plus Medical Cover Gown K212698Plus Medical Isolation Gown Level 3 K212610Surgical Face Mask

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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