(24 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device is a patient examination glove made from nitrile latex compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
The provided text is a 510(k) Summary for a medical device: "Powder Free Nitrile Examination Gloves (Black)". This document doesn't describe the kind of acceptance criteria or study that would have the information requested in your prompt (e.g., sample size for training sets, expert qualifications, MRMC studies, effect sizes). The submission is for a Class I general hospital and personal use device, which typically requires a demonstration of substantial equivalence to a predicate device rather than extensive clinical efficacy studies.
Instead, the document focuses on showing that the new device meets established ASTM and ISO standards for examination gloves and is substantially equivalent to another legally marketed glove.
Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions (Length) | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | Physical Dimensions (Palm Width) | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions (Thickness) | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Tensile Strength) | Min 14 MPa | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Elongation before aging) | Min 500% | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Elongation after aging) | Min 400% | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Non-sensitization and Non-irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No adverse biological reaction | no evidence of systemic toxicity. |
Missing Information (Not applicable or not provided in the document for this type of device and submission):
- Sample size used for the test set and the data provenance: Not explicitly stated for each test. The tests refer to established standards (e.g., ASTM, ISO), which would define sample sizes within their methodologies. Data provenance is not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by compliance with established physical and biocompatibility standards, not expert consensus on diagnostic imaging.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring human adjudication of results.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by existing, widely recognized industry standards and test methods (ASTM and ISO standards) for physical properties and biocompatibility of examination gloves.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
§ 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.