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FDA 510(k)

Medical Surgical Gowns

K-Number: K202844 · 2021-01-06

ApplicantBeijing Biosis Healing Biolog Ical Technology Co., Ltd.
Decision Date2021-01-06
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Gowns is a medical device manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under approval number K202844. 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 Medical Surgical Gowns?

Medical Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K202844.

When was Medical Surgical Gowns approved by the FDA?

Medical Surgical Gowns received FDA 510(k) clearance on 2021-01-06, under approval number K202844.

What company makes Medical Surgical Gowns?

Medical Surgical Gowns is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd..

What is the FDA product code for Medical Surgical Gowns?

The FDA product code for Medical Surgical Gowns is FYA.

Related Clinical Trials

NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING

Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K202029Medical Surgical Mask K201641Disposable Laparoscope Trocar K201243Disposable Specimen Retrieval Bag K203622Medical Gloves K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads K231513Oral Matrix

View all 7 devices →

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.

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