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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Irvin, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Sep 27, 2021. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website offers the “Irvin KN95 PPE Mask” and “Disposable Face Mask” for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19***1*** in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 807.39