(115 days)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document describes the acceptance criteria and study proving the device meets them for Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASMT D6319-19 - Physical Dimensions Test (Width) | Small size: 80 ± 10 mm | |
| Medium size: 95 ± 10 mm | ||
| Large size: 110 ± 10 mm | ||
| Extra-large size: 120 ± 10 mm | Small size: 82mm (Minimum), 82 mm (Mean), 85 mm (Maximum) | |
| Medium size: 91 mm (Minimum), 92 mm (Mean), 93 mm (Maximum) | ||
| Large size: 108 mm (Minimum), 109 mm (Mean), 110 mm (Maximum) | ||
| Extra-large size: 121 mm (Minimum), 122 mm (Mean), 125 mm (Maximum) | ||
| All Passed | ||
| ASMT D6319-19 - Physical Dimensions Test (Length) | Small size: 220 mm (Minimum) | |
| Medium size: 230 mm (Minimum) | ||
| Large size: 230 mm (Minimum) | ||
| Extra-large size: 230 mm (Minimum) | Small size: 232 mm (Mean), 230 mm (Minimum) | |
| Medium size: 242 mm (Mean), 240 mm (Minimum) | ||
| Large size: 239 mm (Mean), 237 mm (Minimum) | ||
| Extra-large size: 243 mm (Mean), 240 mm (Minimum) | ||
| All Passed | ||
| ASMT D6319-19 - Physical Dimensions Test (Thickness) | Small size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | |
| Medium size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | ||
| Large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | ||
| Extra-large size: Finger – 0.05 mm (Minimum), Palm – 0.05 mm (Minimum) | Small size: Finger – 0.13 mm (Mean), 0.12 mm (Minimum); Palm – 0.08 mm (Mean), 0.08 mm (Minimum) | |
| Medium size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) | ||
| Large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.09 mm (Minimum) | ||
| Extra-large size: Finger – 0.14 mm (Mean), 0.13 mm (Minimum); Palm – 0.09 mm (Mean), 0.08 mm (Minimum) | ||
| All Passed | ||
| ASMT D6319-19 - Physical Requirements Test (Tensile Strength & Elongation) | Before Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 500% (Minimum) | |
| After Acceleration Aging: Tensile Strength 14 MPa (Minimum), Ultimate Elongation 400% (Minimum) | Before Acceleration Aging: Tensile Strength 31 MPa (Mean), 17 MPa (Minimum); Ultimate Elongation 563% (Mean), 520% (Minimum) | |
| After Acceleration Aging: Tensile Strength 41 MPa (Mean), 28 MPa (Minimum); Ultimate Elongation 555% (Mean), 524% (Minimum) | ||
| Passed | ||
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - Residual Powder |
§ 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.