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510(k) Data Aggregation
(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 | <50 ug/g | Met <50 ug/g |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test (e.g., for dimensions, physical properties, water tight test). It refers to "inspection levels" (S-2, G-1) and AQL (Acceptable Quality Limit) values, which are used in statistical sampling plans for quality control, but the specific number of units sampled per lot is not provided.
The data provenance is from physical property tests, 1000ml water tight tests, biocompatibility tests, and residual powder content tests performed on the "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue". The study is inherently a prospective test of newly manufactured gloves against established standards. The country of origin of the data is not explicitly stated beyond the applicant being UG Healthcare (USA) Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (gloves) for which ground truth is established by objective physical and chemical measurements against recognized standards (e.g., ASTM D6319-10, FDA 1000 ml water test). It does not involve expert interpretation or diagnosis.
4. Adjudication method for the test set
Not applicable. Testing is based on objective physical/chemical measurements and statistical sampling plans (AQL) against predefined thresholds, not human adjudication of subjective data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, this is not an AI device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, including:
- ASTM D 6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ISO 2859-1 (Sampling procedures for inspection by attributes)
- ISO 9001:2008 & ISO 13485:2003 (Quality management systems)
- FDA 1000 ml water test (for watertight integrity)
- Specific minimum/maximum thresholds for physical properties (e.g., tensile strength, elongation, dimensions, powder residue).
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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