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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:

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 (This document is now withdrawn and unavailable.)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.