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FDA 510(k)

Blockade Surgical Gown

K-Number: K150598 · 2016-04-28

ApplicantMedline Industries, Inc.
Decision Date2016-04-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Blockade Surgical Gown is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-04-28 under approval number K150598. 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 Blockade Surgical Gown?

Blockade Surgical Gown is a medical device that received FDA 510(k) clearance on 2016-04-28. It is manufactured by Medline Industries, Inc.. The 510(k) number is K150598.

When was Blockade Surgical Gown approved by the FDA?

Blockade Surgical Gown received FDA 510(k) clearance on 2016-04-28, under approval number K150598.

What company makes Blockade Surgical Gown?

Blockade Surgical Gown is manufactured by Medline Industries, Inc..

What is the FDA product code for Blockade Surgical Gown?

The FDA product code for Blockade Surgical Gown is FYA.

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Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. 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. K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.

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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