FDA 510(k)

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

K-Number: K210143 · 2021-07-22

ApplicantFoshan Nanhai Plus Medical Co, Ltd.

Decision Date2021-07-22

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is a medical device manufactured by Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-07-22 under approval number K210143. 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 Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K210143.

When was Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) approved by the FDA?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) received FDA 510(k) clearance on 2021-07-22, under approval number K210143.

What company makes Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is manufactured by Foshan Nanhai Plus Medical Co, Ltd..

What is the FDA product code for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

The FDA product code for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is FYA.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Foshan Nanhai Plus Medical Co, Ltd.

K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) K213177Plus Medical Cover Gown K211036Plus Medical Chemotherapy 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

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