(84 days)
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 Nitrile Examination Gloves. 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 document describes the acceptance criteria and study results for "Nitrile Examination Gloves" (K212551). The device is a non-sterile, powder-free, single-use patient examination glove made from nitrile compound.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
---|---|---|---|
Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves | Width: | |
80mm ±10mm (small) | |||
95mm ±10mm (medium) | |||
110 mm ±10mm (large) | |||
Length: | |||
220mm (Min) (small) | |||
230 mm (Min) (medium, large) | |||
Thickness: | |||
Finger - 0.05 mm (Min) | |||
Palm - 0.05 mm (Min) | Width: | ||
small size: 81 to 89mm | |||
medium size: 91 to 98mm | |||
large size: 109 to 111mm | |||
Length: | |||
small size: 230mm (minimum) | |||
medium size: 240mm (minimum) | |||
large size: 244mm (minimum) | |||
Thickness: | |||
Finger: small size: 0.12mm (minimum), medium size: 0.13mm (minimum), large size: 0.13mm (minimum) | |||
Palm: small size: 0.08mm (minimum), medium size: 0.08mm (minimum), large size: 0.08mm (minimum) | |||
Result: Passed | |||
Physical Requirements (ASMT D6319-19) | To determine 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): 26 (Minimum) | |||
Ultimate Elongation (%): 538 (Minimum) | |||
After Acceleration Aging: | |||
Tensile Strength (MPa): 25 (Minimum) | |||
Ultimate Elongation (%): 511 (Minimum) | |||
Result: Passed | |||
Freedom from Holes (ASTM D6319-19 (ASTM D5151-11)) | To determine the holes in the gloves | AQL 2.5 | Result: Passed |
Residual Powder (ASMT D6319-19 (ASTM D6124-11)) | 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.