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510(k) K191355

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask by 3M Healthcare — Product Code FXX

K191355 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask". The FDA issued a decision of Substantially Equivalent on September 11, 2019. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. 3M Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2019
Date Received
May 21, 2019
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

Other clearances by 3M Healthcare

  • K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (March 13, 2020)
  • K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face S (July 31, 2018)
  • K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (March 16, 2018)
  • K171116 — 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/18 (August 10, 2017)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)
  • K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (July 26, 1998)
  • K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (May 15, 1998)
  • K974553 — 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (February 3, 1998)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)

FDA data resources