Cardinal Health 4211PG - GOWN, IMPERVIOUS, THMBHOKS, UNIV, 100 EA/CS
Cardinal Health 4211PG First to Market AAMI Level 4 Protective Gown with 510(k) Clearance
This over-the-head AAMI 4 protective gown is made of blue coated polypropylene material with open-back for breathability and comfort. Coverage on the front and sides provides protection from high fluid levels and blood borne pathogens. Option for knit cuffs or thumbhook wrist style and is available in universal and XL sizes.
- First to Market AAMI Level 4 Protective Gown with 510(k) Clearance*
- Poly-coated Protective Gown
- Provides high fluid protection
The FDA now requires non-sterile gowns with moderate or high fluid claims, which includes AAMI Level 4, to have 510(k) clearance.
| Type | Cat. No. | Size/Description | Qty. |
| Over-the-head, thumbhooks | 4211PG | Universal, blue | 10/pk, 100/cs (flat pack) |
AAMI Level 4: AAMI Level 4 gowns provide the highest level of barrier protection according to the Association for the Advancement of Medical Instrumentation (AAMI) standards. They are designed to protect against significant exposure to fluids, including blood, and are suitable for use in high-risk situations.
510(k) Clearance: A 510(k) clearance is a pre-market submission made by medical device manufacturers to the U.S. Food and Drug Administration (FDA) to demonstrate that their device is safe and effective. Having 510(k) clearance ensures that the gown has met regulatory standards and can be legally marketed in the United States.
Multi-Ply Construction: These gowns typically have multiple layers of material, often including materials like polypropylene, polyethylene, or other specialized barrier fabrics. The multi-ply construction enhances durability and protective properties.
High Fluid Resistance: AAMI Level 4 gowns offer the highest level of fluid resistance, making them suitable for procedures and environments where there is a substantial risk of exposure to blood and bodily fluids.
Neck and Waist Ties: The gown usually features ties around the neck and waist to ensure a secure and adjustable fit.
Elastic Cuffs: Elastic cuffs at the wrists provide a secure fit and minimize the risk of exposure around the wrists.
Open Back: Some AAMI Level 4 gowns may have an open-back design, allowing for easy donning and doffing.
AAMI PB70 guidelines
Benefits of Cardinal Health 4211PG AAMI Level 4 Protective Gown
Maximum Protection: AAMI Level 4 gowns offer the highest level of protection against fluids, particulate matter, and infectious materials, providing an exceptional level of safety for healthcare workers and patients.
Durability: The multi-ply construction enhances the gown's durability, making it suitable for use in demanding healthcare environments.
Secure Fit: Ties at the neck and waist, along with elastic cuffs, ensure a secure fit, minimizing the risk of exposure in critical areas.
Size Variety: Different sizes are available to accommodate healthcare workers of varying body types, enhancing overall comfort and protection.
Versatility: AAMI Level 4 gowns are suitable for use in high-risk procedures, surgery, and other healthcare situations where maximum barrier protection is required.
Technical Information of Cardinal Health 4211PG AAMI Level 4 Protective Gown
Material Composition: AAMI Level 4 gowns are typically constructed from multiple layers of specialized materials to provide a high level of barrier protection. These materials may include polypropylene, polyethylene, and other barrier fabrics designed to resist fluid penetration.
Weight: The weight of the gown can vary depending on the specific materials used, but they are generally heavier than lower-level gowns due to the additional layers required for maximum protection.
Fluid Resistance: AAMI Level 4 gowns are designed to offer the highest level of fluid resistance. They should be tested and certified to resist penetration by blood, bodily fluids, and other potentially infectious materials.
Seam Construction: The seams of AAMI Level 4 gowns are typically reinforced and sealed to minimize the risk of fluid penetration at the seams. The seams are an important aspect of the gown's barrier properties.
Cuff Type: The gown's cuffs are often equipped with elastic bands to provide a snug fit around the wrists, reducing the risk of exposure.
Back Design: Some AAMI Level 4 gowns may have an open-back design for easy donning and doffing, while others may have a closed-back design with a secure closure mechanism.
Regulatory Compliance: The 510(k) clearance indicates that the gown manufacturer has submitted documentation to the U.S. Food and Drug Administration (FDA) to demonstrate that the gown meets regulatory requirements for safety and effectiveness.
Sterility: Depending on the intended use, some AAMI Level 4 gowns may be supplied sterile, while others are non-sterile. Sterility is important for certain surgical procedures.
