(95 days)
A disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.
The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| 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: | ||
| For M: 95 ± 10mm | ||||
| For L: 110 ± 10mm | ||||
| For XL: 120 ± 10mm | ||||
| Length: | ||||
| For M: ≥230mm | ||||
| For L: ≥230mm | ||||
| For XL: ≥230mm | ||||
| Thickness: | ||||
| Finger: ≥0.05mm | ||||
| Palm: ≥0.05mm | Width: | |||
| For M: 93~96mm | ||||
| For L: 104-107mm | ||||
| For XL: 112~116mm | ||||
| Length: | ||||
| For M: 236~239mm | ||||
| For L: 236~239mm | ||||
| For XL: 255~258mm | ||||
| Thickness: | ||||
| For M: Finger: 0.06 | ||||
| For L: Finger: 0.06 | ||||
| For XL: Finger: 0.08 | Passed | |||
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Properties Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% | ||
| After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% | |||
| After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed | |||
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Pass at 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.