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FDA 510(k)

Medical Surgical Mask (Planar type)

K-Number: K220824 · 2022-05-19

ApplicantHunan Chopard Medical Devices Co., Ltd.
Decision Date2022-05-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask (Planar type) is a medical device manufactured by Hunan Chopard Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under approval number K220824. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Surgical Mask (Planar type)?

Medical Surgical Mask (Planar type) is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Hunan Chopard Medical Devices Co., Ltd.. The 510(k) number is K220824.

When was Medical Surgical Mask (Planar type) approved by the FDA?

Medical Surgical Mask (Planar type) received FDA 510(k) clearance on 2022-05-19, under approval number K220824.

What company makes Medical Surgical Mask (Planar type)?

Medical Surgical Mask (Planar type) is manufactured by Hunan Chopard Medical Devices Co., Ltd..

What is the FDA product code for Medical Surgical Mask (Planar type)?

The FDA product code for Medical Surgical Mask (Planar type) is FXX.

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)

Related Devices (Code: FXX)

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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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