(155 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011) | Meets ( |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.