Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Plus Medical Cover Gown

K-Number: K213177 · 2022-05-11

ApplicantFoshan Nanhai Plus Medical Co, Ltd.
Decision Date2022-05-11
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plus Medical Cover Gown is a medical device manufactured by Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-05-11 under approval number K213177. 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 Cover Gown?

Plus Medical Cover Gown is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K213177.

When was Plus Medical Cover Gown approved by the FDA?

Plus Medical Cover Gown received FDA 510(k) clearance on 2022-05-11, under approval number K213177.

What company makes Plus Medical Cover Gown?

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

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

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

Related Clinical Trials

NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT05741866 Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) COMPLETED NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING NCT07071935 A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

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) 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

View on FDA Database →

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

↑