FDA 510(k)

Skypro, Surgical Gown 6021

K-Number: K230707 · 2023-10-12

ApplicantSkypro Medical Supplies Company

Decision Date2023-10-12

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Skypro, Surgical Gown 6021 is a medical device manufactured by Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2023-10-12 under approval number K230707. 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 Skypro, Surgical Gown 6021?

Skypro, Surgical Gown 6021 is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Skypro Medical Supplies Company. The 510(k) number is K230707.

When was Skypro, Surgical Gown 6021 approved by the FDA?

Skypro, Surgical Gown 6021 received FDA 510(k) clearance on 2023-10-12, under approval number K230707.

What company makes Skypro, Surgical Gown 6021?

Skypro, Surgical Gown 6021 is manufactured by Skypro Medical Supplies Company.

What is the FDA product code for Skypro, Surgical Gown 6021?

The FDA product code for Skypro, Surgical Gown 6021 is FYA.

Other Devices by Skypro Medical Supplies Company

K152197Skypro, SP01 Mask K202255Skypro, SP02 Mask (3)

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

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