SMTL Glove Protein Information Sheet May 1999
Introduction.
This information sheet summarises the results of protein testing carried out by SMTL on various brands of gloves. Data from this document should be read in the context of the whole document, and not in isolation.
It includes the following data:
- Test results from the All Wales Gloves contract for 1998/1999. The protein testing was performed during the periods October-December 1997 and January-February 1998, on batches of gloves submitted by each of the manufacturers.
- Test results from the All Wales Gloves contract for 1999/2001. The protein testing was performed during the periods October-December 1998 and January 1999, on batches of gloves submitted by each of the manufacturers.
- Test results from commercial work carried out by SMTL for various manufacturers. This data has been reproduced here with the express permission of the manufacturers in question.
- In the next few months, SMTL will be undertaking a monitoring exercise on the quality of gloves on the All Wales contract. This will entail sampling gloves from Hospital Supplies departments and testing to the EN standards. The results will be reproduced here.
WARNING: Some of this data was generated over a year ago - manufacturers can and do change their processes, so the data in this document does not necessarily reflect the current protein levels by these manufacturers. If you require protein data to make a purchasing decision, request the manufacturer for up-to-date (i.e., within the last 3 months) independent test data. Historical data (i.e., protein data over a 2 year period) would also be helpful to you in showing how their protein levels have been controlled.
Testing is to the draft European Standard, prEN 455-3, using a modified Lowry test. The 1997/98 results were performed using a draft that stated that the lower limit of protein detection was 5µg/g latex. The latest revision of this standard states that the lower limit is now 10µg/g latex. This is the reason for the differences in the lower detection limit from one year to another.
The Surgical Materials Testing Laboratory (SMTL) was NAMAS/UKAS accredited for carrying out this testing up to August 1998. In August 1998, SMTL moved to new labs. Under UKAS rules, you must suspend accreditation when you move premises until you are re-inspected in your new location. Thus SMTL have voluntarily suspended their accreditation while waiting for a UKAS visit (due July 1999). All testing is still, however, performed to the same standard and quality system as before the move.
Please note that the modified Lowry test detects all proteins, not just those causing latex allergy, and is susceptible to interfering substances such as accelerators and surfactants. See "Aspects of glove safety", Phillips P., Journal of Wound Care, October 1996, (suppl: Hand Care: The Risks), for more information.
Further information on glove selection and protein levels can be found in the MDA Device bulletin, MDA DB 9601. (This document is now withdrawn and unavailable.)
Results: 1998/1999 All Wales Contract
1998/99 All Wales Contract: Total extractable protein content of powder-free latex examination gloves.
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Anglia Vale textured | Qtexx | 20.99 | 24.33 | 24.10 | 20.83 |
Ansell | No Powder | 18.77 | 18.90 | 18.66 | 19.92 |
Healthline | Latex | 13.22 | 13.93 | 15.18 | 17.83 |
Shermond | Protector latex | 40.77 | 51.28 | 40.78 | 47.15 |
Browne | Oon non chlorinated | 49.26 | 53.68 | 50.73 | 53.87 |
Hanfare | Finetouch | 41.12 | 45.67 | 55.80 | 57.25 |
Healthline | Latex | 13.22 | 13.93 | 15.18 | 17.83 |
BDF | Glovex Ultra | 8.46 | 15.03 | 7.69 | 6.18 |
J & J | Microtouch | 48.18 | 55.03 | 66.34 | 50.26 |
Polyco | Finex | <5* | <5* | <5* | <5* |
Medisavers | Dermagrip | 16.56 | 14.23 | 19.98 | 16.88 |
Molnlycke | Glads | 19.72 | 15.67 | 11.78 | 12.04 |
Surgicon | Latex | 9.10 | 10.92 | 9.51 | 10.27 |
Safeskin | Satin Plus | 43.4 | 38.1 | 46.4 | 39.2 |
PFE powder free | 23.9 | 26.5 | 17.2 | 40.1 | |
Semperit | Sempermed | *<5.0 | *<5.0 | *<5.0 | 13.59 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 5µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1998/99 All Wales Contract: Total extractable protein content of powdered latex examination gloves
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Ansell | Fitted examination | 79.90 | 70.10 | 78.94 | 73.87 |
Healthline | Lightly powdered | 97.39 | 111.07 | 113.37 | 127.48 |
Surgicon | Lightly powdered | 296.42 | 278.90 | 279.29 | 302.42 |
Semperit | Sempermed powdered | 112.4 | 93.1 | 87.1 | 97.2 |
¶ Ovalbumin Equivalent Protein
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1998/99 All Wales Contract: Total extractable protein content of latex surgeons gloves
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Ansell | Nutex with Dermashield | <5.0* | <5.0* | <5.0* | 10.81 |
Gammex powdered | 58.64 | 68.87 | 70.99 | 63.35 | |
Healthline | Absogel powderfree | 27.68 | 32.61 | 32.15 | 39.24 |
J & J | Microtouch powderfree | 83.74 | 68.18 | 128.27 | 85.07 |
Kendall | Prolax Gel powderfree | 57.13 | 63.83 | 62.99 | 64.10 |
Regent | Biogel powderfree | 42.91 | 30.84 | 12.17 | 18.03 |
Semperit | Supreme powderfree | 74.9 | 90.5 | 60.8 | 42.7 |
Semperit | Derma-Plus powdered | 71.11 | 71.92 | 87.62 | 85.67 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 5\(*mg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1998/1999 All Wales Contract: Total extractable protein content of non-sterile powder-free latex procedure gloves (non-sterile surgeons).
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Schottlander | Dental procedure powderfree | <5* | <5* | <5* | <5* |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 5µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
Results: 1999/2001 All Wales Contract
1999/2001 All Wales Contract: Total extractable protein content of non-sterile powder-free latex examination gloves.
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
BDF | Glovex Ultra | <10* | <10* | <10* | <10* |
Healthline | Latex | <10* | <10* | <10* | <10* |
Medisavers | Bodyguards | <10* | <10* | <10* | <10* |
Polyco | Finex PF | <10* | <10* | <10* | <10* |
Finex PF Micro textured | <10* | <10* | <10* | <10* | |
Surgicon | Latex | <10* | 22.3 | 16.1 | 13.6 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 10µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1999/2001 All Wales Contract: Total extractable protein content of sterile powder-free latex surgeons gloves.
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
J&J | Microtouch | <10* | 18.13 | <10* | 12.69 |
Kendall | Prolax Gel | 52.1 | 51.6 | 42.9 | 47.0 |
Medisavers | Profeel | <10* | <10* | <10* | <10* |
Regent | Biogel | <10* | <10* | 10.4 | 11.1 |
Semperit | Supreme | 22.8 | 30.3 | 20.1 | 22.0 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 10µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1999/2001 All Wales Contract: Total extractable protein content of non-sterile powder-free latex procedure gloves (non-sterile surgeons).
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Schottlander | Dental procedure powderfree | <10* | <10* | <10* | <10* |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 10µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
Results: 1999 Commercial Testing
1999 Commercial Testing: Total extractable protein content of non-sterile powder-free latex examination gloves.
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
Shermond (Mar 1999) | Premier powderfree non-sterile examination gloves |
20.5 | 20.2 | 20.9 | 23.0 |
Premier Protectors powderfree non-sterile examination gloves |
19.2 | 20.4 | 23.6 | 35.7 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 10µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
1999 Commercial Testing: Total extractable protein content of sterile powder-free latex surgeons gloves.
Manufacturer | Product | Total Extractable Protein¶ (µg/g) | |||
1 | 2 | 3 | 4 | ||
CR Services (Feb/Mar 1999) | Profile 3000 Latex surgeons powderfree gloves |
19.5 | 20.9 | 23.3 | 23.8 |
¶ Ovalbumin Equivalent Protein
* The lower limit of protein determination is 10µg/g latex using the prEN455-3 test method.
NOTE: Data from this table should be read in the context of the whole document, and not in isolation.
Copyright
This document is published by the Surgical Materials Testing Laboratory. The information contained in this document is proprietary and copyright of the Surgical Material Testing Laboratory (SMTL). It shall not be reproduced for commercial purposes in part or in whole without the written approval of SMTL.
For further information, please contact SMTL directly.