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

FDA 510(k)

CiRx (R) Surgical Mask

K-Number: K210256 · 2021-08-19

ApplicantNingbo Shun YE Medical Company, Ltd.
Decision Date2021-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CiRx (R) Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K210256. 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 CiRx (R) Surgical Mask?

CiRx (R) Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K210256.

When did CiRx (R) Surgical Mask receive FDA 510(k) clearance?

CiRx (R) Surgical Mask received FDA 510(k) clearance on 2021-08-19, under 510(k) number K210256.

Who is the listed applicant for CiRx (R) Surgical Mask?

The FDA 510(k) record lists Ningbo Shun YE Medical Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CiRx (R) Surgical Mask?

The FDA product code for CiRx (R) Surgical Mask is FXX.

Other records listing Ningbo Shun YE Medical Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213786CiRX Single use electrosurgical pencil with non-coated and coated electrode

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.

↑