Biogel(R) Gloves Have Met Newest FDA Guidelines For Many Years

For many years, Biogel(R) gloves, manufactured by Molnlycke Health Care US, LLC, have featured AQL (Acceptable Quality Level) for freedom from holes well below the recommended maximums that the Food and Drug Administration (FDA) will be requiring in two years.

Effective December 19, 2008, the new FDA maximum AQL for exam gloves will be 2.5 percent and 1.5 percent for surgical gloves. By lowering AQLs, the FDA is requiring higher barrier standards for the gloves which should result in fewer occurrences of bloodborne pathogen transmissions between patients and healthcare workers.

"We're pleased that the FDA is raising the requirements for all surgical and exam glove manufacturers," explains Milt Hinsch, technical services director. "However, the ruling isn't surprising as most US glove manufacturers have been meeting the new standards for a couple of years already. Additionally, this brings the FDA more in line with benchmarks used by two other influential regulators -- the International Organization for Standardization (ISO) and ASTM International (ASTM)."

"Molnlycke offers a full line of Biogel sterile surgical gloves, which have been the industry's gold standard for years," Hinsch adds. "In addition to being the only major medical glove company with an exclusively powder-free glove line, our surgical gloves in the US maintain a freedom from holes AQL of 1.0 percent. This exceeds both the new standard from the FDA and existing ASTM AQL of 1.5 percent."

The Biogel clinical team recommends the use of latex, deproteinised latex and non-latex gloves to address all needs across general surgery, general exam, and specialty needs as steps in creating a Latex-SAFE environment. Hospitals and surgical centers should always opt for powder-free glove choices as part of a Latex-SAFE environment to decrease the risk of latex sensitization.

About Molnlycke Health Care US, LLC

Molnlycke Health Care US, LLC, consists of two divisions - Surgical and Wound Care. Focusing on prevention of surgically-related infections for both patients and healthcare workers, the Surgical Division (formerly Regent Medical Americas, LLC) encompasses the world's leading manufacturer and supplier of powder-free surgical gloves (Biogel(R) surgical gloves); the number one supplier (by value) of skin cleanser (Hibiclens(R) and Hibistat(R) antiseptics); and BARRIER(R) protective clothing. A leader in trauma and pain management, the Wound Care Division's market dynamics are driven by an aging population, higher incidence of pressure ulcers and increased home treatment.

Molnlycke Health Care US, LLC
Molnlycke Health Care