FDA 510(k)

ProPel SG3 Surgical Gown

K-Number: K241214 · 2024-09-10

Decision Date2024-09-10

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ProPel SG3 Surgical Gown is a medical device manufactured by Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2024-09-10 under approval number K241214. 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 ProPel SG3 Surgical Gown?

ProPel SG3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2024-09-10. It is manufactured by Standard Textile Co., Inc.. The 510(k) number is K241214.

When was ProPel SG3 Surgical Gown approved by the FDA?

ProPel SG3 Surgical Gown received FDA 510(k) clearance on 2024-09-10, under approval number K241214.

What company makes ProPel SG3 Surgical Gown?

ProPel SG3 Surgical Gown is manufactured by Standard Textile Co., Inc..

What is the FDA product code for ProPel SG3 Surgical Gown?

The FDA product code for ProPel SG3 Surgical Gown is FYA.

Other Devices by Standard Textile Co., Inc.

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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.