In the ASTM acceptance standard for testing rubber surgical gloves (D3577) and rubber medical gloves (D3578), made of latex, vinyl, and nitrile. The standard describes the standard size, material properties, physical and mechanical property acceptance levels, aqueous protein and antigen protein content, and visual inspection required for a glove to be used in a medical procedure. Other relevant standards include ASTM D6319, ASTM D5250, EN 455-2, ISO 11193-1:2002, and ISO/AWI 11193-2.
ADMET Single Column Testing and Dual Column Testing Systems can be used to test the physical and mechanical properties of the gloves
Summary:
Classification
- Type 1 – Gloves compounded primarily from natural rubber latex
- Type 2 – Gloves compounded from a rubber cement or from synthetic rubber latex
Sampling reference- ISO2859 and Table 1-ASTM D3577 full spec.
Referee Tests:
- Sterility Test
- Freedom from Holes
- Physical Dimensions Test
- Precision and Bias
- Physical Requirements Test:
- Gloves will be tested according to ASTM D412. (Testing video)
- Accelerated Aging according to ASTM D573 (option a or b):
- 70 +-2 degrees Celsius for 22+-0.3 hours
- 100+-2 degrees Celsius for 22+-0.3 hours
- Precision and Bias are specified in ASTM D412
- Powder Free Gloves residue determined by ASTM D6124.
- Aqueous Extractable Protein Content determined by ASTM D5712
- Powdered Glove residue determined by ASTM D6124
- Antigenic Protein Content determined by ASTM D6499
- Dimensions and Tolerance Chart labeled Table 2 describes the length, width, and thickness sizes that are acceptable to this standard.
| Type | Tensile Strength | Elongation | 500% Elongation |
|
Type |
24 MPa, min | 750%, min | 5.5MPa, max |
|
Type |
18 MPa, min | 560%, min | |
|
Type Before Aging |
17MPa, min | 650%, min | 7.0MPa, max |
|
Type |
12MPa, min | 490%, min |
Equipment required:
- Universal testing machine, tensile testing machine, with these minimum specifications: Single Column eXpert 7600 series, Dual Column eXpert 2600 series
- Servo-controlled to keep a constant rate of speed during the test (+/- 2 inches/min)
- At least 30 inches of crosshead travel or more for high elongation materials.
- MTESTQuattro PC Based data acquisiton, data analysis, and reporting software. MTESTQuattro allows viewing real time XY plot, data report showing a description of the glove, tensile strength, elongation, and comments, as well as a statistical summary of multiple samples following the same test procedure.
This is a summary of the standard. For a full, detailed description go to the ASTM website.
Click on these links for more information:
