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)

Surgical Gown

K-Number: K212812 · 2022-11-16

ApplicantXianning Marveldas Protective Articles Co., Ltd.
Decision Date2022-11-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown is a medical device manufactured by Xianning Marveldas Protective Articles Co., Ltd.. It received FDA 510(k) clearance on 2022-11-16 under approval number K212812. 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 Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-11-16. It is manufactured by Xianning Marveldas Protective Articles Co., Ltd.. The 510(k) number is K212812.

When was Surgical Gown approved by the FDA?

Surgical Gown received FDA 510(k) clearance on 2022-11-16, under approval number K212812.

What company makes Surgical Gown?

Surgical Gown is manufactured by Xianning Marveldas Protective Articles Co., Ltd..

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

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.

↑