(73 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 (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
Device Acceptance Criteria and Performance Study Analysis:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria (from predicate "Substantially equivalent") | Reported Device Performance (Dehai Nitrile Examination Gloves) |
|---|---|---|
| Material | Substantially equivalent to predicate | Nitrile Latex (NBR), Sulfur, Accelerator (ZDBC), Zinc Oxide, Potassium Hydroxide, Titanium Dioxide, and Stabilizer. (Deemed substantially equivalent to predicate's materials) |
| Before Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 29.00 Mpa |
| Before Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 750% |
| After Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 24.00 Mpa |
| After Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 700% |
| Overall Length on Medium Size (mm) | Substantially equivalent to predicate | Average over 230mm |
| Width of Palm on Medium Size (mm) | Substantially equivalent to predicate | Average 95mm |
| Film Thickness (mm) | Substantially equivalent to predicate | Average 0.073 mm |
| Finger Thickness (mm) | Substantially equivalent to predicate | Average 0.090 mm |
| Residual Powder (mg/glove) | Substantially equivalent to predicate (no more than 2 mg powder per glove based on ASTM D6124-06) |
§ 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.