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FDA 510(k)

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)

K-Number: K223068 · 2022-11-23

ApplicantGuangdong Golden Leaves Technology Development Co., Ltd.
Decision Date2022-11-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is a medical device manufactured by Guangdong Golden Leaves Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under approval number K223068. 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 Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Guangdong Golden Leaves Technology Development Co., Ltd.. The 510(k) number is K223068.

When was Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) approved by the FDA?

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) received FDA 510(k) clearance on 2022-11-23, under approval number K223068.

What company makes Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is manufactured by Guangdong Golden Leaves Technology Development Co., Ltd..

What is the FDA product code for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

The FDA product code for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is FXX.

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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: 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) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (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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