(252 days)
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. A 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 the patient and the examiner.
Summary of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
This document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue" (K112012), not an AI device. Therefore, many of the requested sections related to AI device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.
Here's the available information based on the provided text, adapted to the closest relevant categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Powder Residue | Maximum 2mg/glove | Not explicitly stated, but implies meeting this |
| Quality Assurance | In compliance with ASTM D6319-10, ISO 2859-1, ISO9001:2008, ISO 13485:2003 | Stated as being in compliance |
| Dimensions (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Physical Properties (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Water Tight Test (1000ml, Inspection) | AQL 1.5 (G-1 level) | Met both before and after aging |
| Visual Major Defects (Inspection) | AQL 1.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Visual Minor Defects (Inspection) | AQL 2.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Overall Length | 240 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Width (medium glove) | 95 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Thickness | 0.05 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| BEFORE AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| AFTER AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 400% minimum | 400% minimum |
| Protein Labeling Claim Level |
§ 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.