Protectaide Biohazard Clean-Up Kit No. B3069

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

510(k) Number

K942476 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Protectaide Personal Protection Pack No. 12351

  Class II

  FDA 510(k) K942475 Active Cleared 18 Oct 1994

• Protectaide Personal Protection Pack No. 24592

  Class II

  FDA 510(k) K942473 Active Cleared 18 Oct 1994

• Protectaide Personal Protection Pack No. 08315

  Class II

  FDA 510(k) K942470 Active Cleared 18 Oct 1994

• Protectaide Biohazard Clean-Up Kit No. 29777

  Class II

  FDA 510(k) K942471 Active Cleared 18 Oct 1994

• Protectaide Personal Protection Pack No. 18000

  Class II

  FDA 510(k) K942474 Active Cleared 18 Oct 1994

• Protectaide Aviator Cpr Protection Pack No. 31000

  Class II

  FDA 510(k) K942467 Active Cleared 6 Oct 1994

See all devices from Protectaide, Inc. →

• What types of clinical settings is the Protectaide Biohazard Clean-Up Kit No. B3069 intended for use in?

  The kit is designed for clinical settings where biohazardous spills may occur, such as operating rooms, emergency departments, or any area handling procedures involving potential biohazardous substances. Its classification under product code FXX (surgical masks and protective barriers) and clearance for general and plastic surgery applications suggests it is primarily suited for surgical environments where contamination risks are managed.

• Is the Protectaide Biohazard Clean-Up Kit No. B3069 reusable, or is it meant for single-use only?

  The kit is explicitly labeled as a single-use, disposable device, meaning it should not be reused after one application. This design ensures safety and sterility, as reuse could compromise containment and decontamination integrity, particularly when handling biohazardous materials.

• How should the Protectaide Biohazard Clean-Up Kit No. B3069 be stored, and what precautions should be taken?

  The kit is supplied as a sterile assembly, so storage must adhere to biohazard safety protocols to maintain sterility and functionality. It should be kept in a clean, dry environment, protected from contamination, and handled only by trained personnel familiar with biohazard containment procedures. Avoid exposure to extreme temperatures or moisture, as these could degrade the materials.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The kit received FDA clearance through a 510(k) submission (K942476), classified as Substantially Equivalent (SESE) under product code FXX for surgical masks and protective barriers. This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing its use in clinical settings where biohazardous spill containment is required—specifically within general and plastic surgery contexts as referenced in the submission.