(297 days)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Viny| 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 linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Here is an analysis of the acceptance criteria and study information for the device, based on the provided text:
Acceptance Criteria and Device Performance Study
The device in question is the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". Its performance is demonstrated through testing against established ASTM standards and FDA regulations for examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported 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 (specifically, Meets ASTM D5151-06 (Reapproved 2011) Holes at Inspection Level I AQL2.5) |
| 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.