Cleared Traditional

PRIMED Surgical and Procedure Masks

K252964 · Primed Medical Products, Inc. · General Hospital
Nov 2025
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K252964 is an FDA 510(k) clearance for the PRIMED Surgical and Procedure Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 4, 2025, 48 days after receiving the submission on September 17, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K252964 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2025
Decision Date November 04, 2025
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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