Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile

K-Number: K220665 · 2022-06-03

ApplicantExcellent Medical Technology Group Co., Ltd.
Decision Date2022-06-03
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile is a medical device manufactured by Excellent Medical Technology Group Co., Ltd.. It received FDA 510(k) clearance on 2022-06-03 under approval number K220665. 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, Blue, Sterile; Surgical Gown, Blue, Non-Sterile?

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Excellent Medical Technology Group Co., Ltd.. The 510(k) number is K220665.

When was Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile approved by the FDA?

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile received FDA 510(k) clearance on 2022-06-03, under approval number K220665.

What company makes Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile?

Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile is manufactured by Excellent Medical Technology Group Co., Ltd..

What is the FDA product code for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile?

The FDA product code for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile is FYA.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING

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.

↑