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)

Disposable Surgical Gowns

K-Number: K202532 · 2021-08-21

ApplicantAnhui Medpurest Medical Technology Co.,Ltd
Decision Date2021-08-21
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gowns is a medical device manufactured by Anhui Medpurest Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-08-21 under approval number K202532. 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 Disposable Surgical Gowns?

Disposable Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-08-21. It is manufactured by Anhui Medpurest Medical Technology Co.,Ltd. The 510(k) number is K202532.

When was Disposable Surgical Gowns approved by the FDA?

Disposable Surgical Gowns received FDA 510(k) clearance on 2021-08-21, under approval number K202532.

What company makes Disposable Surgical Gowns?

Disposable Surgical Gowns is manufactured by Anhui Medpurest Medical Technology Co.,Ltd.

What is the FDA product code for Disposable Surgical Gowns?

The FDA product code for Disposable Surgical Gowns is FYA.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

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.

↑