(113 days)
The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands 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 text describes a 510(k) premarket notification for "Disposable Nitrile Examination Gloves" (K203805) and compares it to a predicate device (K171422). The FDA letter and the 510(k) summary pertain to the substantial equivalence of a medical device, specifically nitrile examination gloves, to pre-existing devices.
Based on the nature of the device (a Class I, non-powered patient examination glove), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new device is as safe and effective as the predicate device, primarily through non-clinical performance and safety testing. This is not a study of an AI/ML medical device, therefore, many of the requested elements for an AI/ML study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, AI/human effect size, training set details) are not applicable.
Here's the breakdown of the information that is applicable and can be extracted from the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from recognized standards (ASTM, ISO) and are generally comparative to the predicate device.
| Acceptance Criteria Category | Specific Metric/Test | Acceptance Criteria (from Standards/Predicate) | Reported Device Performance (Subject Device K203805) |
|---|---|---|---|
| Physical Properties | Tensile Strength (Before Aging) | 14MPa, min (ASTM D6319) | 14MPa, min (Complies with ASTM D6319) |
| Ultimate Elongation (Before Aging) | 500% min (ASTM D6319) | 500% min (Complies with ASTM D6319) | |
| Tensile Strength (After Aging) | 14MPa, min (ASTM D6319) | 14MPa, min (Complies with ASTM D6319) | |
| Ultimate Elongation (After Aging) | 400% min (ASTM D6319) | 400% min (Complies with ASTM D6319) | |
| Freedom from Holes | Detection of Holes | AQL=2.5 when tested in accordance with ASTM D5151 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 (Complies) |
| Powder Content | Residual Powder | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 (Complies) |
| Biocompatibility | Irritation (ISO 10993-10:2010) | Not an irritant | Under the conditions of the study, not an irritant. Complies with ISO-10993-10. |
| Sensitization (ISO 10993-10:2010) | Not a sensitizer | Under conditions of the study, not a sensitizer. Complies with ISO-10993-10. | |
| Cytotoxicity (ISO 10993-5:2009) | Not cytotoxic | Under the conditions of the study, not cytotoxic. Complies with ISO-10993-5. | |
| Device Dimensions | Length (min) | 220-230 mm (meets ASTM D6319-19 requirements) | S: 220mm, M: 230mm, L: 230mm, XL: 230mm (all min) - Meets ASTM D6319-19 requirements |
| Width (tolerance) | ±5 mm to ±10 mm (based on predicate and subject device details, meets ASTM D6319-19) | S: 80mm, M: 95mm, L: 110mm, XL: 120mm (±10mm) - Meets ASTM D6319-19 requirements | |
| Thickness (Finger and Palm, min) | 0.05 mm (min) (ASTM D6319-19) | Finger: 0.05mm (min), Palm: 0.05mm (min) - Meets ASTM D6319-19 requirements |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for holes, tensile strength, etc.). The provenance of the data is from the manufacturer, Jiangsu Yanfang Medical Technology Co., Ltd. The study type is non-clinical performance and safety testing, not a retrospective or prospective clinical study on patient data. The country of origin for the data is implicitly China, where the manufacturer is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML or diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these physical and biocompatibility tests is established through adherence to standardized laboratory test methods (e.g., ASTM D6319 for physical properties, ISO 10993 for biocompatibility).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader interpretation or disagreement.
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 a medical glove, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by adherence to recognized international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10) for physical properties, barrier integrity, and biocompatibility. Test results are compared against the pass/fail criteria defined within these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.