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FDA 510(k)

Medical mask (Model: KKF-1A)

K-Number: K202316 · 2021-03-03

ApplicantHan Zhaoqing Sporting Goods Company Limited
Decision Date2021-03-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical mask (Model: KKF-1A) is a medical device manufactured by Han Zhaoqing Sporting Goods Company Limited. It received FDA 510(k) clearance on 2021-03-03 under approval number K202316. 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 Medical mask (Model: KKF-1A)?

Medical mask (Model: KKF-1A) is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Han Zhaoqing Sporting Goods Company Limited. The 510(k) number is K202316.

When was Medical mask (Model: KKF-1A) approved by the FDA?

Medical mask (Model: KKF-1A) received FDA 510(k) clearance on 2021-03-03, under approval number K202316.

What company makes Medical mask (Model: KKF-1A)?

Medical mask (Model: KKF-1A) is manufactured by Han Zhaoqing Sporting Goods Company Limited.

What is the FDA product code for Medical mask (Model: KKF-1A)?

The FDA product code for Medical mask (Model: KKF-1A) is FXX.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Han Zhaoqing Sporting Goods Company Limited

K202314Procedure face mask (Model: KKF-2A)

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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