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FDA 510(k)

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply

K-Number: K213970 · 2022-01-23

ApplicantDanameco Medical Joint Stock Corporation
Decision Date2022-01-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is a medical device manufactured by Danameco Medical Joint Stock Corporation. It received FDA 510(k) clearance on 2022-01-23 under approval number K213970. 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 D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is a medical device that received FDA 510(k) clearance on 2022-01-23. It is manufactured by Danameco Medical Joint Stock Corporation. The 510(k) number is K213970.

When was D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply approved by the FDA?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply received FDA 510(k) clearance on 2022-01-23, under approval number K213970.

What company makes D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is manufactured by Danameco Medical Joint Stock Corporation.

What is the FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply 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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