FDA 510(k)

Medical surgical mask

K-Number: K201622 · 2020-11-24

ApplicantGuangdong Kingfa Sci. & Tech.Co., Ltd.

Decision Date2020-11-24

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical surgical mask is a medical device manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2020-11-24 under approval number K201622. 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 surgical mask?

Medical surgical mask is a medical device that received FDA 510(k) clearance on 2020-11-24. It is manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K201622.

When was Medical surgical mask approved by the FDA?

Medical surgical mask received FDA 510(k) clearance on 2020-11-24, under approval number K201622.

What company makes Medical surgical mask?

Medical surgical mask is manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd..

What is the FDA product code for Medical surgical mask?

The FDA product code for Medical surgical mask is FXX.

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Guangdong Kingfa Sci. & Tech.Co., Ltd.

K202139Medical surgical mask K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs K203593Patient Examination Gloves K202107Medical Protective Mask K222612Powder-Free Latex examination gloves K222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

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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.