 |
 |
|
| Our chlorinated latex examination glove is a bio- degradeable product made from 100% natural rubber latex and is compounded in a controlled environment to ensure consistency in the product quality. |
|
| Glove Design |
| A superior glove design to ensure fit for the majority of users with a beaded cuff to allow for easy donning. |
|
| Quality Standards |
| All operations are controlled in a professional manner and with following standards and regulations follows. |
|
 |
FDA Special Requirement, New Requirement when issued. |
|
FDA 1,000 ml, Waterleak Test. |
|
FDA GMP guidelines and SMDA guidelines. |
|
ASTM D3578-99. |
|
ASTM D5151-92. |
|
ASQC/ISO 9000 series for Quality Assurance. |
|
U.S. Pharmacopoeia. |
|
Medical Devices Directive 93/42/ECC. |
|
CE Class 1; Complies with EN 455. |
|
IES-RP-CC-005-87-T. |
|
| Allergens |
| Since allergens fluctuate as residuals during the process of formulating and manufacturing. This may or may not present a reaction problem in skin sensitive individuals Allergic reactions can come from many sources and to protect our customers from high levels of residuals glove production is tested routinely. We maintains a clean environment and take precautions to ensure consistency in low level residuals. |
|
| Proteins |
| Found on all glove products at different level of concentration with a large variation between powdered gloves and chlorinated gloves. Protein may come from a variety of source incleuding chemicals used to formulate, raw rubber, dirty water, improperly set-up dipping and processing lines and other sources. We make sure that the protein is checked on a regular basis by using a modified lowry test and that the levels run consistent within a range of 0.5 mg/1 (ppm). |
|
| Release Agent and Donning Powder |
|
| ABSORBO of Nation Starch is the USP grade cornstarch used because of its low irritation characteristics. ABSORBO is used as a mold release and a lubricant. |
|
| Packaging |
|
|
100 gloves/box |
|
10 boxes/case |
|
| Appearance |
| Natural to White / Off-White |
|
| (Note: Chlorinated gloves will normally have a slight color variation. This due to the chlorinated process and the extra drying process used). |
|
