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FDA 510(k)

Medical surgical mask (Black mask, Level 1 and Level 3)

K-Number: K213450 · 2022-04-05

ApplicantGuangdong Kingfa Sci. & Tech.Co., Ltd.
Decision Date2022-04-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical surgical mask (Black mask, Level 1 and Level 3) is a medical device manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-04-05 under approval number K213450. 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 (Black mask, Level 1 and Level 3)?

Medical surgical mask (Black mask, Level 1 and Level 3) is a medical device that received FDA 510(k) clearance on 2022-04-05. It is manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K213450.

When was Medical surgical mask (Black mask, Level 1 and Level 3) approved by the FDA?

Medical surgical mask (Black mask, Level 1 and Level 3) received FDA 510(k) clearance on 2022-04-05, under approval number K213450.

What company makes Medical surgical mask (Black mask, Level 1 and Level 3)?

Medical surgical mask (Black mask, Level 1 and Level 3) is manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd..

What is the FDA product code for Medical surgical mask (Black mask, Level 1 and Level 3)?

The FDA product code for Medical surgical mask (Black mask, Level 1 and Level 3) is FXX.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (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)

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

K201622Medical surgical mask 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

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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.

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