FDA Reported Adverse Events
FDA’s data for the last ten years shows that tearing or holes in gloves is the #1 reported problem by stakeholders, followed by skin reactions and contaminated products.
Case Studies from FDA Database
| User Problem | Event Text |
| Tear, Rip or Hole in Device | A nurse from critical care unit reported frequent tearing of gloves. Therefore, she had to double glove all night. |
| Exposure to Body Fluids | Nitrile gloves have been breaking during cleaning of the operating rooms post surgical; technicians are exposed to blood and other fluids. |
| Hypersensitivity; Itching Sensation; Tissue Breakdown |
Nurse developed extreme itching, redness and skin breakdown on her hands when the ER department she works at switched gloves. She took two weeks off to rehab her hand, but the problem reoccurred when she used the gloves again. She had a total of five weeks off all together. She is now back in patient care wearing cotton liners under the gloves. |
| Device Contamination | The hospitals reported that the gloves had blood, ink or chemical residue on it. Manufacturer refused to honor the product warranty. Seven hospitals reported the same incident. |
| Labeling Problem | Size large chemo gloves are marked as medium in packaging. |
Source: FDA MAUDE -Manufacturer and User Facility Device Experience. Results limited to product code LZA (nitrile exam gloves).
Not All Gloves Are Created Equal: The SW Difference
| Prevent Tearing | No Skin Allergy | Avoid Contamination |
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| Consistent thickness from tip to cuff |
Use of demineralized water during leaching process to remove contaminants |
Latex Free and Silicone Free |
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As we have been seeing glove demand stabilizing, we are also seeing more offerings of gloves from new manufacturers and existing market brands.
There has been an influx of inferior gloves that are inconsistent in size, texture, have very high AQL’s and often tear very easily when donning.
Dangers of Poor-Quality Gloves
- Risk of Allergy
- Poor Durability
- Ineffective Infection Protection
- Control
- Permeability
- Inferior Barrier Protection
- No Cost Savings
- Illusion of Safety
SW Provides the Solution
SW is the expert in glove manufacturing with 100+ years combined industry experience. The traceability and reliability of our products is guaranteed through our daily commitment to bringing our stakeholders the best quality glove possible.