LEAP Testing Service

Residual Powder on Medical Gloves Analysis
 
I. Scope
This standard is designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves. This standard consists of two test methodologies. Procedure I is a method for the quantification of residual powder on gloves described as non-powdered, powder-free, powderless, no powder, or other words to that effect. Procedure II is a test method for the quantitation of powder (and other filter-retained mass) on powdered gloves.
 
II. Procedure I   Powder Test, Powder-Free Gloves—Total Glove:
1. Prior to use, all glassware and tweezers shall be rinsed with deionized or distilled water.

2. Filter Preparation: Use a 47 mm, 2.7 μm pore size glass microfiber filter and a suction filtration apparatus. Use of a TFE-fluorocarbon or equivalent-rimmed housing base is recommended if filters adhere or tear upon removal from glass-rimmed surface.

3. Insert the filter disk in the filtration apparatus. Apply suction and wash the filter disk with three successive 50 mL portions of deionized or distilled water. Continue suction to remove all traces of water and discard the washings. Remove the filter from the filtration apparatus and transfer it to a rinsed and dried glass petri dish or equivalent. Dry in an oven at 100 6 5°C for 1 h. Store the dried filter in a desiccator prior to use.  Before use, pre-weigh the dried filter, weighing immediately after removal from the desiccator.

4. Sample Selection and Test:  Randomly select five gloves from each lot to be evaluated. Gently remove glove from original container.

5. Place 500 mL of deionized or distilled water into a 1000 mL flask. Water used in this procedure should be at 20 to 25°C.

6. Place a glove into the beaker/flask with 1 to 3 cm of the cuff area stretched over the lip. Hold a portion of the cuff away from the lip to vent air from the beaker/flask and add 250 mL of deionized or distilled water to the inside of the glove, making certain the upper cuff is rinsed as the water is poured. Additional water may be used if coverage on the glove exterior is insufficient, or as needed for vacant space within the glove. However, space must be adequate to allow agitation.

7. Cap the flask with a rubber stopper or other secure cover and agitate for 30 s on a mechanical shaker with a minimum side-to-side or rotational speed of 1.7 Hz (100 cycles/min).

8. Remove the cap and pour the water from the inside of the glove into a 600 mL glass beaker. Repeat with the remaining four samples using the same 250 mL of water contained in the 600 mL glass beaker and the same 500 mL of original water added in previous step.

9. Pour the water from the 600 mL glass beaker and the beaker/flask through the suction filtration unit containing the weighed filter.

10. Rinse the 600 mL glass beaker with 250 mL of deionized or distilled water. Successively add the rinse water to the beaker/flask and into the suction filtration unit containing the weighed filter.

11. Rinse the beaker/flask, cap, filter housing and any other portions of the test apparatus that may contain residual powder to ensure all powder extract is filtered.

12. Continue suction to remove all traces of water and discard the washings. Remove the filter from the filtration apparatus and transfer it to a rinsed and dried glass petri dish or equivalent. Dry in an oven at 100 ± 5°C for 1 h. Cool in a desiccator for 30 min prior to weighing. Weigh immediately after removal from the desiccator.

13. Blank Control—Using a beaker/flask, filter and water identical to that was used for the samples, establish a Blank Control for each of lot of water tested using the same techniques described above. That is, filter 1000 mL of the water. Dry, desiccate, and weigh the filter.
 
Procedure II   Powder Test, Powdered Glove—Total Glove:
1. Prior to use, all glassware and tweezers shall be rinsed with deionized or distilled water.

2. Filter Preparation:  Use a 90 mm, 2.7 μm pore size glass microfiber filter and a suction filtration apparatus. Use of a TFE-fluorocarbon or equivalent rimmed housing base is recommended if filters adhere or tear upon removal from glass rimmed surface.

3. Prepare filter by desiccation a minimum of 30 min prior to use. Before use, pre-weigh the filter, weighing immediately after removal from the desiccator.

4. Sample Selection and Test:  Randomly select two gloves from each lot to be evaluated. Gently remove glove from original container. 

5. Place 500 mL of deionized or distilled water into a 1000 mL recessed neck beaker/flask with pouring rim. All water used in this procedure should be at or below room temperature.

6.Place a glove into the beaker/flask with 1 to 3 cm of the cuff area stretched over the lip. Hold a portion of the cuff away from the lip to vent air from the beaker/flask and add 250 mL of deionized or distilled water to the inside of the glove, making certain to rinse the upper cuff as the water is poured. Additional water may be used if coverage is insufficient on the glove exterior or as needed for vacant space within the glove. However, space must be adequate to allow agitation.

7. Cap the beaker/flask with a rubber stopper with a polypropylene rim shroud or equivalent, agitate for 30 s on a mechanical shaker with a minimum side to side or rotational speed of 1.7 Hz (100 cycles/min).

8. Remove the cap and pour the water from the inside of the glove through the suction filtration unit containing the weighed filter. Remove the glove from the beaker/flask and drain the remaining inside water from the glove through the suction filtration unit. Pour the beaker/flask water contents through the suction filtration unit.

9.Place 500 mL fresh deionized or distilled water into the same 1000 mL recessed neck beaker/flask.

10. Replace the test glove into the same beaker/flask with 1 to 3 cm of the cuff stretched over the lip. Hold a portion of the cuff away from the lip to vent air from the beaker/flask and add 250 mL of fresh deionized or distilled water to the inside of the glove. Additional water may be used if coverage is insufficient. However, space must be adequate to allow agitation.

11. Cap the beaker/flask with the same rubber stopper with a polypropylene rim shroud or equivalent, agitate for 30 s on a mechanical shaker with a minimum speed of 1.7 Hz (100 cycles/minute).

12. Remove the cap and pour the water from the inside of the glove through the suction filtration unit containing the weighed filter. Remove the glove from the beaker/flask and drain the remaining inside water from the glove through the suction filtration unit. Pour the beaker/flask water contents through the suction filtration unit.

13. Repeat on the same glove for an additional two fresh water rinses, constituting a total of four fresh water rinses per single glove.

14. Rinse the beaker/flask, cap, filter housing and any other portions of the test apparatus that may contain residual powder to ensure all powder extract is filtered.

15. Repeat for the second glove, utilizing the same filter and suction device used for the first glove. Only two (2) gloves shall be evaluated per filter.

16. Continue suction to remove all traces of water and discard the washings. Remove the filter from the filtration apparatus and transfer it to a rinsed and dried glass petri dish or equivalent. Dry in an oven at 100 ± 5°C for 1h. Cool in a desiccator for a minimum of 30 min prior to weighing. Weigh immediately after desiccation to prevent moisture absorption.