(114 days)
Disposable Medical Synthetic 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 Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl 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 provided document is a 510(k) summary for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASMT D6319-19) | Width: | |
| 80 mm (±10mm) (for small size) | ||
| 95 mm (±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: (for all sizes) | ||
| Finger -0.05 mm (Minimum) | ||
| Palm -0.05mm (Minimum) | Passed | |
| Physical Requirements (Tensile Strength & Ultimate Elongation) (ASMT D6319-19) | Before Acceleration Aging: | |
| Tensile Strength (MPa): 14 (Minimum) | ||
| Ultimate Elongation (%): 500 (Minimum) | ||
| After Acceleration Aging: | ||
| Tensile Strength (MPa): 14 (Minimum) | ||
| Ultimate Elongation (%): 400(Minimum) | Passed | |
| Freedom from Holes (Water Tight -1000 ml) (ASTM D6319-19 (ASTM D5151-11)) | AQL 2.5 | Passed |
| Residual Powder on Medical Gloves (ASMT D6319-19 (ASTM D6124-11)) |
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.