3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

No FDA recalls found in the data synced 26 Oct 2026.

510(k) Number

K191355 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model 480cm Infusion Pump, Modification

  Class II

  FDA 510(k) K924869 Active Cleared 17 Jun 1993

• 3M Prevention Fabric Surgical Gown #78XX

  Class II

  FDA 510(k) K930681 Active Cleared 10 Feb 1994

• 3M Precise Brand Internal Surgical Staples

  Class II

  FDA 510(k) K921051 Active Cleared 16 Jul 1992

• 3M Pediatric Laparotomy Sheet #7938/ #7938NS

  Class II

  FDA 510(k) K946024 Active Cleared 8 Feb 1995

• 3M X-Large Sheet #7979/ #7979NS

  Class II

  FDA 510(k) K946025 Active Cleared 2 Feb 1995

• Red Dot 2515 Cardiac Sensor System

  Class I

  FDA 510(k) K924487 Active Cleared 23 Dec 1992

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