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FDA 510(k)

Surgical Gowns

K-Number: K210215 · 2021-07-07

ApplicantJiangsu Province Jianerkang Medical Dressing Co., Ltd.
Decision Date2021-07-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gowns is a medical device manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd.. It received FDA 510(k) clearance on 2021-07-07 under approval number K210215. 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 Gowns?

Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-07-07. It is manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd.. The 510(k) number is K210215.

When was Surgical Gowns approved by the FDA?

Surgical Gowns received FDA 510(k) clearance on 2021-07-07, under approval number K210215.

What company makes Surgical Gowns?

Surgical Gowns is manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd..

What is the FDA product code for Surgical Gowns?

The FDA product code for Surgical Gowns is FYA.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING

Other Devices by Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K202061Medical 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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