Surgical Face Mask With Ear-Loop Model YN-501 AB/W/G/P - P

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

510(k) Number

K123115 ↗

FDA Product Code

FXX

Models / Variants

Yn-501 Ab

W

G

P

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• What types of medical procedures is this mask designed for, and why is it suitable for those settings?

  The ACME SURGICAL FACE MASK WITH EAR-LOOP (Model YN-501) is specifically designed for use in general and plastic surgery environments. It provides barrier protection against airborne contaminants, which is critical in surgical settings where minimizing infection risk is essential. The mask meets ASTM F2100 standards for fluid resistance and bacterial filtration efficiency, ensuring reliable performance during procedures where sterility and contamination control are paramount.

• Is this mask reusable, and if not, how should it be disposed of after single use?

  This mask is explicitly labeled as a single-use device, meaning it is intended for one-time use only. After use, it should be discarded in accordance with standard medical waste disposal protocols to prevent cross-contamination and maintain infection control standards in clinical settings.

• What configurations (AB/W/G/P) does this mask come in, and how do they differ?

  The configurations AB/W/G/P refer to variations in the mask’s design or material specifications, though the exact distinctions between them are not detailed in the provided data. Typically, such labels may indicate differences in fluid resistance, filtration efficiency, or color-coding for ease of identification (e.g., AB could denote a specific barrier level, W might indicate a particular fabric type, and G/P could relate to size or additional protective features). For precise usage guidance, refer to the manufacturer’s instructions.

• How should this mask be stored to ensure it remains effective and intact?

  The mask should be stored following the manufacturer’s guidelines to preserve its integrity. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, general best practices for surgical masks include keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains uncompromised until use. Proper storage prevents degradation of filtration performance and structural integrity.

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

  This mask received FDA 510(k) clearance (K123115) under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms the device meets FDA requirements for safety and effectiveness as a surgical face mask in general and plastic surgery settings. The clearance does not imply additional indications beyond its labeled use, so clinicians should adhere to the manufacturer’s instructions for proper application and use.