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FDA 510(k)

Disposable Surgical Gown

K-Number: K210510 · 2021-08-12

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2021-08-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown is a medical device manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval number K210510. 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 Disposable Surgical Gown?

Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K210510.

When was Disposable Surgical Gown approved by the FDA?

Disposable Surgical Gown received FDA 510(k) clearance on 2021-08-12, under approval number K210510.

What company makes Disposable Surgical Gown?

Disposable Surgical Gown is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd..

What is the FDA product code for Disposable Surgical Gown?

The FDA product code for Disposable Surgical Gown is FYA.

Other Devices by Shandong Zhushi Pharmaceutical Group Co., Ltd.

K210643Disposable Surgical Face Mask K210409Disposable Surgical Face Mask K203454Infrared Thermometer K203436Disposable Nitrile Examination Gloves K203439Disposable Vinyl Examination Gloves K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

View all 8 devices →

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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