(93 days)
Disposable Medical Nitrile Examination Gloves (Non Sterile) 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) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.
However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: | |
| 80mm ±10mm (for small size) | |||
| 95mm ±10mm (for medium size) | |||
| 110 mm ±10mm (for large size) | |||
| Length: | |||
| 220 mm (Minimum) (for small size) | |||
| 230 mm (Minimum)(for medium, large size) | |||
| Thickness: | |||
| Finger -0.05 mm (Minimum) (for small, medium, large size) | |||
| Palm -0.05 mm (Minimum)(for small, medium, large size) | Width: | ||
| small size: 82 to 89mm | |||
| medium size: 91 to 96mm | |||
| large size: 115 to 116mm | |||
| Length: | |||
| small size: 230mm (minimum) | |||
| medium size: 240mm (minimum) | |||
| large size: 238mm (minimum) | |||
| Thickness: | |||
| Finger: | |||
| small size: 0.12mm (minimum) | |||
| medium size: 0.13mm (minimum) | |||
| large size: 0.12mm (minimum) | |||
| Palm: | |||
| small size: 0.08 mm (minimum) | |||
| medium size: 0.08mm (minimum) | |||
| large size: 0.09 mm (minimum) | |||
| Passed | |||
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging: | |
| Tensile Strength (MPa): 14 (Minimum) | |||
| Ultimate Elongation (%): 500 (Minimum) | |||
| After Acceleration Aging: | |||
| Tensile Strength (MPa): 14 (Minimum) | |||
| Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging: | ||
| Tensile Strength (MPa): 20 (Minimum) | |||
| Ultimate Elongation (%): 521 (Minimum) | |||
| After Acceleration Aging: | |||
| Tensile Strength (MPa): 19 (Minimum) | |||
| Ultimate Elongation (%): 505 (Minimum) | |||
| Passed | |||
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves |
§ 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.