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FDA 510(k)

Medical Surgical Masks-Non Sterile

K-Number: K202594 · 2021-01-06

ApplicantShandong T&F Nonwoven Co., Ltd.
Decision Date2021-01-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Masks-Non Sterile is a medical device manufactured by Shandong T&F Nonwoven Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under approval number K202594. 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 Masks-Non Sterile?

Medical Surgical Masks-Non Sterile is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Shandong T&F Nonwoven Co., Ltd.. The 510(k) number is K202594.

When was Medical Surgical Masks-Non Sterile approved by the FDA?

Medical Surgical Masks-Non Sterile received FDA 510(k) clearance on 2021-01-06, under approval number K202594.

What company makes Medical Surgical Masks-Non Sterile?

Medical Surgical Masks-Non Sterile is manufactured by Shandong T&F Nonwoven Co., Ltd..

What is the FDA product code for Medical Surgical Masks-Non Sterile?

The FDA product code for Medical Surgical Masks-Non Sterile is FXX.

Related Clinical Trials

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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: 36976820 Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device. PloS one (2023)

Related Devices (Code: FXX)

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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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