Adverse Events in Latex Medical Gloves and Its Solutions

What is adverse event?

Adverse event may be defined as an injury that caused by the medical gloves and that results in measurable disability. Some common adverse events which reported as customer complaint are rash, skin irritation; skin became reddish, allergy reaction, just to name a few.

What are the causes?

There are common causes which triggered the issue are:

• cornstarch powder on powdered gloves
• particulates on gloves
• chemicals residue on the gloves (chlorine, alkaline, polymer, etc)
• natural latex in gloves (latex allergy due to protein)

Cornstarch powder on powdered gloves:

According to FDA, powder on powdered gloves is:

• The major adverse impact of glove powder appears to be its contributing role in natural rubber latex allergies.
• Glove powder acts as an airborne carrier of natural latex proteins.
• Exposure to airborne natural rubber latex allergens can be most effectively reduced by considering both the level of natural latex proteins and the amount of glove powder on medical gloves.

Particulates on gloves:

Particulates found on the gloves can include dusting powder, former-release compounds, lint, dust, colloidal solids, cotton, cellulose, wood fibers, metal, paper particles from packaging, and manufacturing debris. The most common particulates on gloves are dusting powder and former-release compounds added by manufacturers.

Although gloves are labeled as “powder-free”, they contain various amounts of powder or particulates matter. FDA has adopted 2 milligrams particulate weight (based on the ASTM test standard D 6124-01) per glove powder or less as a basis for approving powder-free gloves (refer to D3578-05). However, virtually all glove manufacturers provide particulate weight. For example, a medium size powdered glove may contain about 120-400 milligrams of residual debris, former-release and dusting powder.

Chemicals residue on the gloves (chlorine, alkaline etc)

Chlorinated natural latex gloves and polymer coated are the common technology in producing gloves with less contain of powder and protein. However, poor process control during manufacturing will leave chemical residues on gloves and contributing to adverse event cases

Exposure to airborne natural rubber latex allergens can be most effectively reduced by considering both the level of natural latex proteins and the amount of glove powder on medical gloves.

FDA has included testing of powder and protein in gloves as requirements in Gloves Performance (refer to D3578-05). Low powder or powder free gloves were introduced to the global market as well as synthetic gloves in order to tackle this factor.

Some suggestions to minimize as well as to prevent adverse event

• Product (gloves) – must meet the performance requirements stated in Standard Specification for Rubber Examination Gloves (D3578-05)
• Particulates and protein test should be criteria in shipment approval for H.S.I.
• Manufacturers must be in compliance with GMP (Good Manufacturing Practices) and ISO 9001. Attention must be given to environment and contamination control (see table) during on-site audit.