FDA 510(k)

Biodegradable Medical surgical mask

K-Number: K231155 · 2023-11-07

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

Decision Date2023-11-07

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Biodegradable Medical surgical mask is a medical device manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under approval number K231155. 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 Biodegradable Medical surgical mask?

Biodegradable Medical surgical mask is a medical device that received FDA 510(k) clearance on 2023-11-07. It is manufactured by Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K231155.

When was Biodegradable Medical surgical mask approved by the FDA?

Biodegradable Medical surgical mask received FDA 510(k) clearance on 2023-11-07, under approval number K231155.

What company makes Biodegradable Medical surgical mask?

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

What is the FDA product code for Biodegradable Medical surgical mask?

The FDA product code for Biodegradable 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: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) 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)

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.