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FDA 510(k)

PRIMED Surgical and Procedure Masks

K-Number: K252964 · 2025-11-04

ApplicantPrimed Medical Products, Inc.
Decision Date2025-11-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMED Surgical and Procedure Masks is a medical device manufactured by Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2025-11-04 under approval number K252964. 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 PRIMED Surgical and Procedure Masks?

PRIMED Surgical and Procedure Masks is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Primed Medical Products, Inc.. The 510(k) number is K252964.

When was PRIMED Surgical and Procedure Masks approved by the FDA?

PRIMED Surgical and Procedure Masks received FDA 510(k) clearance on 2025-11-04, under approval number K252964.

What company makes PRIMED Surgical and Procedure Masks?

PRIMED Surgical and Procedure Masks is manufactured by Primed Medical Products, Inc..

What is the FDA product code for PRIMED Surgical and Procedure Masks?

The FDA product code for PRIMED Surgical and Procedure Masks is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Primed Medical Products, Inc.

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3) K213427PRIMED Pediatric Facemask K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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