(78 days)
The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for a Blue Nitrile Exam Glove, Powder Free. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or therapeutic product. Therefore, it does not contain the information required to answer the specific questions related to acceptance criteria, test sets, expert involvement, MRMC studies, or training sets for such a device.
The document primarily focuses on demonstrating that the subject device (the new glove) is "as safe, as effective, and performs as well as or better than" a predicate device (an existing glove) based on non-clinical testing of physical properties and biocompatibility.
Here's how the provided information relates to acceptance criteria, but note it's for a physical medical device (glove) and not an AI system:
1. A table of acceptance criteria and the reported device performance
The document provides tables ("Table3 Performance Comparison" and "Table4 Safety Comparison") that effectively function as a comparison of the subject device's performance against the predicate device, which implies certain performance acceptance criteria are met (i.e., being equivalent or better than the predicate, which itself met standards).
Here's an interpretation of the performance and safety "acceptance criteria" and "reported device performance" based on the provided tables:
| Item | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device K210058) |
|---|---|---|
| Physical Properties (Before Aging) | ||
| Tensile Strength | 14 MPa, min (Comply with ASTM D6319) | 14 MPa, min |
| Ultimate Elongation | 500% min (Comply with ASTM D6319) | 500% min |
| Physical Properties (After Aging) | ||
| Tensile Strength | 14 MPa, min (Comply with ASTM D6319) | 14 MPa, min |
| Ultimate Elongation | 400% min (Comply with ASTM D6319) | 400% min |
| Freedom from Holes | ||
| Test Method | Be free from holes when tested in accordance with ASTMD5151 | Be free from holes when tested in accordance with ASTMD5151 |
| AQL | AQL=2.5 | AQL=2.5 |
| Powder Content | ||
| Limit | 0.05 mg per glove (Meet requirements of ASTM D6124) | 0.05 mg per glove |
| Biocompatibility | ||
| Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant |
| Sensitization (ISO 10993-10) | Not a sensitizer | Under conditions of the study, not a sensitizer |
| Cytotoxicity (ISO 10993-5) | Device extract is not cytotoxic | Under conditions of the study, device extract is not cytotoxic |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for these tests (e.g., how many gloves were tested for tensile strength or holes). It refers to standard test methods (e.g., ASTM D6319, ASTM D5151), which would define the sample sizes for those tests. The data provenance is implied to be from the manufacturer's own testing facilities in China ("Great Harvest Trading Co., Ltd." in Shandong, China). The testing is non-clinical, not retrospective or prospective in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical glove, not an AI system requiring expert consensus on medical images or diagnoses. The "ground truth" here is objective physical and chemical measurements (e.g., direct measurement of strength, elongation, hole presence, chemical content).
4. Adjudication method for the test set
Not applicable. The tests are standard objective measurements, not subjective human assessments requiring adjudication.
5. 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/ML-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-based diagnostic device.
7. The type of ground truth used
The ground truth for this device's performance is established by objective physical and chemical testing standards, such as ASTM D6319 for physical properties, ASTM D5151 for holes, ASTM D6124 for powder content, and ISO 10993 for biocompatibility. These are laboratory measurements, not expert consensus, pathology, or outcomes data in the medical imaging/diagnosis context.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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.