Surgical Gown
K-Number: K192560 · 2020-05-22
Decision Date2020-05-22
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Gown is a medical device manufactured by Shandong Kangli Medical Equipment Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-22 under approval number K192560. 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?
Surgical Gown is a medical device that received FDA 510(k) clearance on 2020-05-22. It is manufactured by Shandong Kangli Medical Equipment Technology Co., Ltd.. The 510(k) number is K192560.
When was Surgical Gown approved by the FDA?
Surgical Gown received FDA 510(k) clearance on 2020-05-22, under approval number K192560.
What company makes Surgical Gown?
Surgical Gown is manufactured by Shandong Kangli Medical Equipment Technology Co., Ltd..
What is the FDA product code for Surgical Gown?
The FDA product code for Surgical Gown is FYA.
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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.