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FDA 510(k)

Single-use Medical Face Mask

K-Number: K203591 · 2021-07-02

ApplicantConod Medical Co., Limited
Decision Date2021-07-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use Medical Face Mask is a medical device manufactured by Conod Medical Co., Limited. It received FDA 510(k) clearance on 2021-07-02 under approval number K203591. 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 Single-use Medical Face Mask?

Single-use Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Conod Medical Co., Limited. The 510(k) number is K203591.

When was Single-use Medical Face Mask approved by the FDA?

Single-use Medical Face Mask received FDA 510(k) clearance on 2021-07-02, under approval number K203591.

What company makes Single-use Medical Face Mask?

Single-use Medical Face Mask is manufactured by Conod Medical Co., Limited.

What is the FDA product code for Single-use Medical Face Mask?

The FDA product code for Single-use Medical Face Mask is FXX.

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (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: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by Conod Medical Co., Limited

K181276CONOD Enteral Feeding Sets

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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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