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FDA 510(k)

Procedure face mask (Model: KKF-2A)

K-Number: K202314 · 2021-01-13

ApplicantHan Zhaoqing Sporting Goods Company Limited
Decision Date2021-01-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure face mask (Model: KKF-2A) is a medical device manufactured by Han Zhaoqing Sporting Goods Company Limited. It received FDA 510(k) clearance on 2021-01-13 under approval number K202314. 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 Procedure face mask (Model: KKF-2A)?

Procedure face mask (Model: KKF-2A) is a medical device that received FDA 510(k) clearance on 2021-01-13. It is manufactured by Han Zhaoqing Sporting Goods Company Limited. The 510(k) number is K202314.

When was Procedure face mask (Model: KKF-2A) approved by the FDA?

Procedure face mask (Model: KKF-2A) received FDA 510(k) clearance on 2021-01-13, under approval number K202314.

What company makes Procedure face mask (Model: KKF-2A)?

Procedure face mask (Model: KKF-2A) is manufactured by Han Zhaoqing Sporting Goods Company Limited.

What is the FDA product code for Procedure face mask (Model: KKF-2A)?

The FDA product code for Procedure face mask (Model: KKF-2A) is FXX.

Related Clinical Trials

NCT05984563 Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass TERMINATED NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT04036695 Arrhythmia in Hemodialysis Patients ACTIVE_NOT_RECRUITING NCT07367620 Immediate Mechanical Complications After Central Venous Catheterization COMPLETED NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT07520630 Neurophysiological Markers for Prediction of Rehabilitation Outcomes After Ischemic Stroke NOT_YET_RECRUITING

Other Devices by Han Zhaoqing Sporting Goods Company Limited

K202316Medical mask (Model: KKF-1A)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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