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FDA 510(k)

Surgical Gown, Model: surgical gown-hp-3

K-Number: K210355 · 2021-12-16

ApplicantWeihai Dishang Medical Technology Co., Ltd.
Decision Date2021-12-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown, Model: surgical gown-hp-3 is a medical device manufactured by Weihai Dishang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-16 under approval number K210355. 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, Model: surgical gown-hp-3?

Surgical Gown, Model: surgical gown-hp-3 is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Weihai Dishang Medical Technology Co., Ltd.. The 510(k) number is K210355.

When was Surgical Gown, Model: surgical gown-hp-3 approved by the FDA?

Surgical Gown, Model: surgical gown-hp-3 received FDA 510(k) clearance on 2021-12-16, under approval number K210355.

What company makes Surgical Gown, Model: surgical gown-hp-3?

Surgical Gown, Model: surgical gown-hp-3 is manufactured by Weihai Dishang Medical Technology Co., Ltd..

What is the FDA product code for Surgical Gown, Model: surgical gown-hp-3?

The FDA product code for Surgical Gown, Model: surgical gown-hp-3 is FYA.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07589946 Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases COMPLETED NCT07557238 CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China NOT_YET_RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07530133 Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery NOT_YET_RECRUITING

Other Devices by Weihai Dishang Medical Technology Co., Ltd.

K210348Disposable Medical Surgical 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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