510(k) K221682

Ideal Med Pro 3-Ply Disposable Face Mask by Jsn Holdings, LLC — Product Code FXX

K221682 is an FDA 510(k) premarket notification submitted by Jsn Holdings, LLC for the device "Ideal Med Pro 3-Ply Disposable Face Mask". The FDA issued a decision of Substantially Equivalent on Jan 13, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 13, 2023
Date Received
Jun 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type
510(k)