Yadu Medical Face Mask Level 1

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

510(k) Number

K212330 ↗

FDA Product Code

FXX

FDA applicant

Henan Yadu Industrial Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Medical Face Masks

  Class I

  CE/MDR

• Absorbent Cotton Wool

  Class I

  CE/MDR

• Surgical Drape

  Class I

  CE/MDD

• Scrub Suit

  Class I

  CE/MDR

• Surgical Gown

  Class I

  CE/MDD

• Cotton Swab Sticks

  Class I

  CE/MDR

See all devices from Henan YADU Industrial Co., Ltd →

• What clinical environments is this mask intended for, and how does its single-use design support infection control?

  The Yadu Medical Face Mask (Level 1) is designed for single-use in clinical settings, specifically to reduce infection transmission during procedures in general and plastic surgery environments. Its disposable nature ensures that each patient encounter uses a fresh barrier, minimizing cross-contamination risks between patients or healthcare workers. This aligns with infection control protocols where reusable masks may harbor pathogens over time.

• How should I store this mask, and what does the sterile packaging mean for clinical use?

  The mask is supplied in sterile packaging, meaning it is pre-sterilized to eliminate microorganisms before use. Storage instructions are detailed in the manufacturer’s documentation, but generally, sterile single-use devices like this should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. The sterility ensures immediate readiness for use without additional sterilization steps, which is critical in time-sensitive clinical procedures.

• Are there any size or model variations for this mask, and how do I know which one to select for my patients?

  The provided data does not specify size or model variations for the Yadu Medical Face Mask (Level 1). Since it is classified under product code FXX (general medical face masks), it likely follows standard sizing conventions (e.g., small, medium, large) common to disposable surgical masks. For precise sizing guidance, refer to the manufacturer’s packaging or instructions, as fit is critical for effective barrier protection and comfort during use.

• Can this mask be reused, and what are the implications of its single-use classification for cost management?

  This mask is explicitly designed for single-use only, meaning it should not be reused or reprocessed. While this may increase per-patient costs compared to reusable alternatives, the single-use classification aligns with infection control best practices by eliminating potential contamination from repeated use. Healthcare facilities should factor this into inventory planning to ensure adequate stock levels for patient throughput.

• Does this mask have any restrictions on use with medical imaging equipment, such as MRI machines?

  The manufacturer does not specify any MRI safety restrictions for the Yadu Medical Face Mask (Level 1). However, since it is a disposable medical device, it is unlikely to contain metallic components that could interfere with MRI scans. For absolute certainty, always verify compatibility with your facility’s MRI protocols or consult the manufacturer’s documentation, as non-metallic materials may still pose risks in rare cases.