(29 days)
Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered 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 e1.
The provided document describes the acceptance criteria and performance of "Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Hongxin Plastic Products Co.,Ltd. It's important to note that this is a medical device (gloves), not an AI algorithm, so many of the questions related to AI studies (like MRMC studies, training sets, expert ground truth for imaging, etc.) are not applicable.
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Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | 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.