(186 days)
ZM 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 glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided document describes the FDA 510(k) summary for ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). This is a medical glove, which is a Class I device and does not involve AI/ML. Therefore, many of the typical questions regarding AI/ML device studies are not applicable.
Here's the information that can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard / Acceptance Criteria | Device performance |
|---|---|---|
| Dimension | ASTM D5250-06(Reapproved 2011) | Meets |
| Physical Properties | ASTM D5250-06(Reapproved 2011) | Meets |
| Freedom from pinholes | 21 CFR 800.20 (and ASTM D5151-06) | Meets (Holes at Inspection Level I AQL2.5) |
| Powder Residual | ASTM D5250-06(Reapproved 2011) & D6124-06(Reaffirmation 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.