Fluidshield Surgical Masks

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Modification Tecnol Fluidshield Surgical Masks

510(k) Number

K913043 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bedpan, Single Patient Use, Tecnol

  Class I

  FDA 510(k) K760307 Active Cleared 11 Aug 1976

• I.V. Support, Tecnol Armboard

  Class I

  FDA 510(k) K760308 Active Cleared 11 Aug 1976

• Tecnol Fog-Free Surgical Mask W/Derma-Touch Tape

  Class II

  FDA 510(k) K873785 Active Cleared 2 Nov 1987

• Tecnol Compression Knee Dressing

  Class II

  FDA 510(k) K873368 Active Cleared 11 Dec 1987

• Tecnol Variable Tension Bandage

  Class I

  FDA 510(k) K884440 Active Cleared 17 Jan 1989

• Tecnol Patient Use Ice Pack

  Class II

  FDA 510(k) K760782 Active Cleared 2 Dec 1976

See all devices from Tecnol New Jersey Wound Care, Inc. →

• Are these masks reusable or designed for single-use only, and how does that affect their sterility?

  These Fluidshield Surgical Masks are explicitly designed for single-use only and come in a sterile packaging. Since they are intended to be discarded after one use, sterility is maintained until the package is opened, ensuring a clean surgical environment without the risk of cross-contamination from reuse.

• What types of surgical procedures are these masks primarily intended for, and why?

  The masks are primarily intended for general and plastic surgery settings, as indicated by their FDA classification under product code FXX and the advisory committee designation for General, Plastic Surgery. Their design focuses on protecting against fluid exposure from splashes, sprays, or droplets, which is critical in procedures where contamination risks are higher.

• How are these masks supplied, and what should I check before using them?

  The masks are supplied in sterile, single-use packaging, meaning each mask is individually sealed and ready for immediate use. Before use, verify the sterility seal is intact and that the package has not been compromised. Since they are single-use, do not reuse even if they appear undamaged.

• What does the FDA’s 510(k) clearance (K913043) mean for these masks, and how does it relate to their safety?

  The FDA 510(k) clearance (K913043) confirms that these masks are substantially equivalent to a legally marketed predicate device, meaning they meet the agency’s safety and effectiveness requirements for surgical masks under Class II regulation. This clearance does not imply ongoing approval but confirms the device’s compliance with FDA standards at the time of review (1991).