Accelerator-free disposable gloves (nitrile)
Level: Core
Use of disposable gloves and laboratory gloves may lead to skin irritation and/or sensitisation to substances with contact allergenic properties. Thiurams, thiazoles and carbamates are accelerators and known contact allergens. It is therefore important that disposable gloves can be tendered that does not contain accelerators, and that can be used by staff with proven allergies.
Details
- Type:
- Technical specification
- ID:
- 11217
- Group:
- Disposable gloves for medical use
Criterion text
The following groups of chemicals shall not be used in the manufacture of tendered accelerator-free disposable nitrile gloves:
Accelerators or components known to form accelerators, such as thiurams, dithiocarbamates and thiazoles (see the Chemicals and allergens in the manufacturing of disposable gloves attachment)
Verification
The supplier shall, upon request, be able to present any of for example the following:
A test result showing the amounts of chemical residues shall be supplied together with tendered gloves, along with the specified limit of detection for each chemical (analyte). The tests shall be conducted according to the description given below:The glove material shall be extracted using a relevant organic solvent, such as acetonitrile or acetone, followed by an HPLC analysis of the dithiocarbamate, thiazole and thiuram content. To be able to detect 1,3-diphenylguanidine (DPG), alcohol may also be used as an extraction medium. It shall be stated which solvent is used; or,
Analysis of substances in the material of disposable gloves:
The glove material shall be extracted using a relevant organic solvent, such as acetonitrile or acetone, followed by an HPLC analysis of the dithiocarbamate, thiazole and thiuram content. To be able to detect 1,3-diphenylguanidine (DPG), alcohol may also be used as an extraction medium. It shall be stated which solvent is used.
The supplier’s self-declaration, including technical documentation of compliance, shall be verified by an accredited verification body that is accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
The above-mentioned test for extraction with a subsequent analysis shall be carried out if there is any doubt regarding the possible content of accelerators.
Obtain a chemical residue test result for the gloves. The test should be conducted at an independent laboratory.
If there is any doubt concerning whether an tendered glove is accelerator free and the wearer experiences discomfort when using it, extraction can be carried out according to the test procedure described above, and the chemical residue content and any accelerators can be analysed.
Currently, there is no standardised analytical method; instead, analysis can be carried out at an independent laboratory. If it is important to know which accelerators have been used, the test should be conducted using an organic solvent as the extraction medium.
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.
Information about the criterion
The tenderer or supplier shall be able to provide information regarding all stages of production. If it is required that gloves shall not contain a certain substance or chemical, it shall not be used in the manufacturing process. It is possible to test polyvinyl chloride (PVC) gloves to detect specific phthalates.
A list of chemicals used in the glove in the product data sheet sheet helps users with known allergies to certain rubber chemicals to be able to avoid gloves with such additives. A list is also helpful when examining suspected rubber allergy in glove users. Possible chemicals and known allergens that can be used in production are listed in the attachment "Chemicals and allergens in the manufacture of disposable gloves".
It is important to indicate which chemicals are used, and any residues in the final product. At present, there is no standard for how residual chemicals can be controlled. Different test methods are used to measure chemical residues and it is important that the tenderer states which test method has been used to determine the content of residual chemicals. It is important to know that tendered gloves are completely free of accelerators so that they can be used by staff with known allergies to any of these substances, see appendix "Chemicals and allergens in the manufacture of disposable gloves".
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.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11217
- Version date
- 2018-06-05
- Review date
- 2022-01-31