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FDA 510(k)

Medical Surgery Mask, Model:2626-7

K-Number: K220067 · 2022-08-30

ApplicantDongguan Missadola Technology Co., Ltd.
Decision Date2022-08-30
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgery Mask, Model:2626-7 is a medical device manufactured by Dongguan Missadola Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under approval number K220067. 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 Surgery Mask, Model:2626-7?

Medical Surgery Mask, Model:2626-7 is a medical device that received FDA 510(k) clearance on 2022-08-30. It is manufactured by Dongguan Missadola Technology Co., Ltd.. The 510(k) number is K220067.

When was Medical Surgery Mask, Model:2626-7 approved by the FDA?

Medical Surgery Mask, Model:2626-7 received FDA 510(k) clearance on 2022-08-30, under approval number K220067.

What company makes Medical Surgery Mask, Model:2626-7?

Medical Surgery Mask, Model:2626-7 is manufactured by Dongguan Missadola Technology Co., Ltd..

What is the FDA product code for Medical Surgery Mask, Model:2626-7?

The FDA product code for Medical Surgery Mask, Model:2626-7 is FXX.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) 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)

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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