High Filtration Iso-Mask

• 2 recalls, same reason

  • Ongoing Z-0729-2025 FDA Class II ·initiated 8 Nov 2024
  • Ongoing Z-0728-2025 FDA Class II ·initiated 8 Nov 2024

  Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

510(k) Number

K831148 ↗

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. →