Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

K-Number: K180874 · 2018-07-31

Applicant3M Healthcare
Decision Date2018-07-31
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device manufactured by 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under approval number K180874. 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 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. It is manufactured by 3M Healthcare. The 510(k) number is K180874.

When was 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield approved by the FDA?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under approval number K180874.

What company makes 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is manufactured by 3M Healthcare.

What is the FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT06364865 AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study COMPLETED

Other Devices by 3M Healthcare

K153571Cavilon Advanced High Endurance Skin Protectant K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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.

↑