(32 days)
A 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.
The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.
The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.
Acceptance Criteria and Device Performance:
The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.
| Characteristics | Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 3578 - 01 | Meets ASTM D 3578 - 01 | Meets |
| Physical Properties | ASTM D 3578 - 01 | Meets ASTM D 3578 - 01 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01 | ||
| FDA 21 CFR 800.20 | Meets ASTM D 3578 - 01 and FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 - 00 |
§ 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.