Sensitizing (allergenic) compounds in disposable gloves

At the start of the contract or at another time during the contract period, request that information be submitted about constituent substances in the gloves and check for the inclusion of substances of very high concern (Candidate List). Ensure that the gloves do not contain any known contact allergens, in accordance with the Chemicals and allergens in the manufacturing of disposable gloves attachment.

If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard. 

The tenderer or supplier shall be able to provide information regarding all stages of production. A list in the product data sheet showing chemicals used in the gloves helps users with known allergies to certain rubber chemicals to be able to avoid gloves containing such additives. A list is also helpful when investigating a suspected rubber allergy for an individual using the gloves. Potential allergens that may be used in production are listed, and it is important that the chemicals used are indicated along with any residues in the final product. See the Chemicals and allergens in the manufacturing of disposable gloves attachment. 

There is currently no standard for how residual chemicals can be checked. Various test methods are used to measure chemical residues, and it is important that the tenderer specifies which method has been used. The manufacturer can only confirm the absence of a certain chemical if it has not been used in any part of the manufacturing process; that is, no chemical can be used in production that is known to have adverse health effects.

There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website. 

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