(251 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-06 and FDA requirements) | Reported Device Performance (Zibo Intco Medical Products) |
|---|---|
| Physical and Dimensions Testing: | Inspection Level S-2, AQL 2.5 was met. |
| - Tensile Strength (Mpa) - Before Aging | Average 19.2 Mpa |
| - Ultimate Elongations (%) - Before Aging | Average 501% |
| - Tensile Strength (Mpa) - After Aging | Average 16.8 Mpa |
| - Ultimate Elongations (%) - After Aging | Average 472% |
| - Overall Length (Medium Size) | Average over 249mm (Meets predicate's "Substantially equivalent") |
| - Width of Palm (Medium Size) | Average 95mm (Meets predicate's "Substantially equivalent") |
| - Palm Thickness | Average 0.085 mm (Meets predicate's "Substantially equivalent") |
| - Figure Thickness | Average 0.088 mm (Meets predicate's "Substantially equivalent") |
| Key Performance Attributes: | |
| - Residual Powder (per glove) |
§ 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.