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FDA 510(k)

Medical Surgical Mask (Model: JM92, JM92B)

K-Number: K220187 · 2022-03-25

ApplicantGuangdong Jia Mei Biological Technology Co.Ltd
Decision Date2022-03-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask (Model: JM92, JM92B) is a medical device manufactured by Guangdong Jia Mei Biological Technology Co.Ltd. It received FDA 510(k) clearance on 2022-03-25 under approval number K220187. 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 (Model: JM92, JM92B)?

Medical Surgical Mask (Model: JM92, JM92B) is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Guangdong Jia Mei Biological Technology Co.Ltd. The 510(k) number is K220187.

When was Medical Surgical Mask (Model: JM92, JM92B) approved by the FDA?

Medical Surgical Mask (Model: JM92, JM92B) received FDA 510(k) clearance on 2022-03-25, under approval number K220187.

What company makes Medical Surgical Mask (Model: JM92, JM92B)?

Medical Surgical Mask (Model: JM92, JM92B) is manufactured by Guangdong Jia Mei Biological Technology Co.Ltd.

What is the FDA product code for Medical Surgical Mask (Model: JM92, JM92B)?

The FDA product code for Medical Surgical Mask (Model: JM92, JM92B) is FXX.

Related Clinical Trials

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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: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (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)

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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