(83 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
This document describes the premarket notification (510(k)) for a medical device, specifically "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". It is not an AI/ML medical device submission. Therefore, the questions related to AI/ML specific studies, such as MRMC studies, ground truth establishment by experts, and training/test set sample sizes for AI/ML models, are not applicable.
The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K190942) by meeting established performance standards for patient examination gloves.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance & Comparison Analysis
The document provides a detailed comparison in "Table 1" and further test results in section "7.0 Summary of Non-Clinical Testing".
| CHARACTERISTICS | STANDARDS / Acceptance Criteria | Predicate Performance (K190942) | Subject Device Performance (K233740) | Comparison Analysis (Outcome) |
|---|---|---|---|---|
| Physical Properties | ASTM D6319-19 | |||
| Before Aging: | ||||
| - Tensile Strength | Min 14.0 MPa (Acceptance) | 14 Mpa, min | 15.7 – 39.8 Mpa (XS-XXL range) | Different but within the ASTM standard |
| - Ultimate Elongation | Min 500% (Acceptance) | 500% min | 550 - 620% (XS-XXL range) | Different but within the ASTM standard |
| After Aging: | ||||
| - Tensile Strength | Min 14.0 MPa (Acceptance) | 14 Mpa, min | 17.0 – 40.6 Mpa (XS-XXL range) | Different but within the ASTM standard |
| - Ultimate Elongation | Min 400% (Acceptance) | 400% min | 460 - 600% (XS-XXL range) | Different but within the ASTM standard |
| Dimensions | ASTM D6319-19 | |||
| Length | 230 mm min | 230 mm min | Min 240 mm | Different but within the ASTM standard |
| Thickness (Finger) | 0.05mm min | 0.05mm min | Min 0.13mm (XS-XXL) | Different but within the ASTM standard |
| Thickness (Palm) | 0.05mm min | 0.05mm min | Min 0.09mm (XS-XXL) | Different but within the ASTM standard |
| Powder Free | ASTM D6124 |
§ 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.