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FDA 510(k)

Face Mask

K-Number: K210007 · 2021-04-23

ApplicantJinhua Jingdi Medical Supplies Co., Ltd.
Decision Date2021-04-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jinhua Jingdi Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210007. 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 Face Mask?

Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Jinhua Jingdi Medical Supplies Co., Ltd.. The 510(k) number is K210007.

When did Face Mask receive FDA 510(k) clearance?

Face Mask received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210007.

Who is the listed applicant for Face Mask?

The FDA 510(k) record lists Jinhua Jingdi Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Face Mask?

The FDA product code for Face Mask is FXX.

Related Clinical Trials

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.

NCT03422302Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung CancerRECRUITINGNCT05701839Airway Management During Deep Sedation in HysteroscopyCOMPLETEDNCT06744790Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory SensorCOMPLETEDNCT07019701Gas Composition in the Hypopharynx During High-flow or Standard Oxygen Therapy Through Face Mask in Healthy VolunteersCOMPLETEDNCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITINGNCT07558265WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency DepartmentNOT_YET_RECRUITING

Other records listing Jinhua Jingdi Medical Supplies Co., 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.

K232333Anti-bacterial bandage

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.

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