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FDA 510(k)

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

K-Number: K202697 · 2021-05-13

ApplicantUnited Sewing Automation, Inc.
Decision Date2021-05-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask is the device name listed in this FDA 510(k) record. The listed applicant is United Sewing Automation, Inc.. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K202697. 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 United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask?

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is United Sewing Automation, Inc.. The 510(k) number is K202697.

When did United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask receive FDA 510(k) clearance?

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask received FDA 510(k) clearance on 2021-05-13, under 510(k) number K202697.

Who is the listed applicant for United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask?

The FDA 510(k) record lists United Sewing Automation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask?

The FDA product code for United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure 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.

NCT07071935A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)RECRUITINGNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITING

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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