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

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

510(k) Number

K873785 ↗

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 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

• Disposable Abdominal Binder

  Class I

  FDA 510(k) K760772 Active Cleared 3 Nov 1976

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

• What is the Tecnol Fog-Free Surgical Mask with Derma-Touch Tape designed for?

  This mask is specifically designed to provide barrier protection for healthcare personnel during surgical procedures. The anti-fog technology ensures clear visibility by preventing eyewear fogging, which is critical for maintaining focus and precision in sterile environments. It meets Type II standards under EN 14683, offering a Bacterial Filtration Efficiency (BFE) of over 98% and a differential pressure of less than 29.4 Pa for effective filtration and breathability.

• How is the Tecnol Fog-Free Surgical Mask with Derma-Touch Tape supplied, and what are its dimensions?

  The mask is supplied in a box containing 50 single-use units. Each mask has a length of 17.8 cm, a width of 9.5 cm, and tie lengths of 83 cm. The Derma-Touch tape enhances secure fitting, ensuring comfort and proper sealing during use.

• Is this mask reusable, and if not, why?

  No, this mask is intended for single-use only. Single-use surgical masks are designed to maintain sterility and hygiene standards during procedures. Reusing masks can compromise their filtration efficiency, barrier protection, and overall safety, making them unsuitable for repeated use in clinical settings.

• What regulatory compliance does the Tecnol Fog-Free Surgical Mask with Derma-Touch Tape meet?

  The mask complies with EN 14683 Type II standards, ensuring high bacterial filtration (BFE > 98%) and breathability (differential pressure < 29.4 Pa). It also adheres to 21 CFR 878.4040 for surgical masks and holds FDA 510(k) clearance (K873785) under the Traditional review pathway, classified under product code FXX.

• How should the Tecnol Fog-Free Surgical Mask with Derma-Touch Tape be stored?

  The mask should be stored in its original packaging to preserve sterility and prevent contamination. Keep it in a cool, dry place away from direct sunlight or extreme temperatures. Avoid storing it in areas with high humidity or exposure to chemicals, as these conditions can degrade the material and compromise its performance.