(142 days)
This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
The subject device is a patient examination glove made of a synthetic nitrile latex compound. It is non-sterile, powder-free, with a polymer inner coating of aloe and Vitamin E (per 21 CFR 880.6250, Class I). The device can be either white or pink in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the Non-Sterile, Powder Free Nitrile Examination Gloves with Polymer Coating, Aloe, Vitamin E, White and Pink device, extracted from the provided document:
Acceptance Criteria and Device Performance
The device is a medical glove, and its performance is evaluated against established ASTM standards and general guidelines for medical gloves.
Table 1: Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria/Standards | Reported Device Performance (Subject Device K142685) |
|---|---|---|
| Indications for Use | Medical Glove Guidance Manual | This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. |
| Device Design | - | A protective garment that covers the hand and wrist with openings for fingers and thumb. |
| Material | ASTM D6319-10 | Nitrile Synthetic latex |
| Single Use | Medical Glove Guidance Manual | Single use |
| Ambidextrous | Medical Glove Guidance Manual | Ambidextrous |
| Sterility | Not applicable | Not applicable |
| Dimensions | ASTM D6319-10 | Meets ASTM D6319-10 |
- Overall Length: 220 mm min (XS, S), 230 mm min (M, L, XL)
- Width (+/- 10 mm): Size XS: 70 mm, Size S: 80 mm, Size M: 95 mm, Size L: 110 mm, Size XL: 120 mm
- Thickness: Finger: 0.05 mm min, Palm: 0.05 mm min |
| Physical Properties | ASTM D6319-10
(aging= 70 +/- 2°C for 166 +/- 2 hrs; 100 +/- 2°C for 22 +/- 0.3 hrs) | Meets ASTM D6319-10 - Tensile Strength: 14 MPa min (before aging), 14 MPa min (after aging)
- Ultimate Elongation: 500% min (before aging), 400% min (after aging) |
| Freedom from Pinholes | ASTM D5151-06 | Meets AQL 2.5, Inspection Level G-1 |
| Residual Powder | 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.