Powder-free disposable gloves
Level: Core
The following requirements ensure that all disposable gloves are powder-free and that powdered gloves are not tendered.
Details
- Type:
- Technical specification
- ID:
- 10249:1
- Group:
- Disposable gloves for medical use
- Swedish:
Criterion text
All tendered disposable gloves shall be free from powder residues, and the amount of powder found in the gloves shall not exceed 2 mg/glove.
The following test methods can be used for determining the amount of powder in all tendered disposable gloves:
- EN ISO 21171 (Medical gloves — Determination of removable surface powder)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Own analytical method (a description must be included)
Verification
The supplier shall, upon request, be able to present any of for example the following:
- The supplier shall, upon request, be able to present any of for example the following:Test result according to EN ISO 21171
- Test result according to ASTM D6124
- Technical documentation verifying that the requirement is met
- 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
Check that the results from the residual powder test are included in the test report for the supplied batch, or request and obtain an independent test result.
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
In the US, the FDA forbade the use of powdered gloves in healthcare on 19 December 2016. The prohibition applies from 1 January 2017, and since that date, powdered gloves have not been permitted to be sold or used in the US. For more information about the prohibition, see: https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder
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
- 10249:1
- Version date
- 2018-06-05
- Review date
- 2022-02-16