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SMTL Glove Protein Information Sheet
Version 1.3, 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, available free to the National Health Service (UK) from the Department of Health at Two Ten, Department of Health, PO Box 410, Wetherby, LS23 7EL quoting reference MDA DB 9601. This document is also available on the Internet .

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)
Manufacturer	Product	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
Safeskin	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)
Manufacturer	Product	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)
Manufacturer	Product	1	2	3	4
Ansell	Nutex with Dermashield	<5.0*	<5.0*	<5.0*	10.81
Ansell	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)
Manufacturer	Product	1	2	3	4
Schottlander	Dental procedure powderfree	<5*	<5*	<5*	<5*

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)
Manufacturer	Product	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*
Polyco	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)
Manufacturer	Product	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

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)
Manufacturer	Product	1	2	3	4
Schottlander	Dental procedure powderfree	<10*	<10*	<10*	<10*

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)
Manufacturer	Product	1	2	3	4
Shermond (Mar 1999)	Premier powderfree non-sterile examination gloves	20.5	20.2	20.9	23.0
Shermond (Mar 1999)	Premier Protectors powderfree non-sterile examination gloves	19.2	20.4	23.6	35.7

1999 Commercial Testing: Total extractable protein content of sterile powder-free latex surgeons gloves.

Manufacturer	Product	Total Extractable Protein¶ (µg/g)
Manufacturer	Product	1	2	3	4
CR Services (Feb/Mar 1999)	Profile 3000 Latex surgeons powderfree gloves	19.5	20.9	23.3	23.8

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.

This site was originally set up with the aid of sponsorship from the Value for Money Unit, Welsh Office and an educational grant from Sophos Convatec.

URL: http://www.smtl.co.uk/MDRC/Gloves/smtl-latex-protein-summary.html
Last Modified: Wednesday, 27-Oct-1999 09:54:00 BST

SMTL Glove Protein Information Sheet Version 1.3, May 1999.