(74 days)
The Disposable Nitrile Gloves are 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 document is a 510(k) Premarket Notification summary for Disposable Nitrile Gloves (K210276). It is not for an AI/ML medical device, but rather for a physical medical device (gloves). Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this document.
The document discusses the substantial equivalence of the Disposable Nitrile Gloves to a predicate device (K171422) based on performance testing and adherence to recognized standards.
Here's an attempt to interpret the provided content in the context of your request, while acknowledging that it doesn't fit the typical AI/ML device evaluation structure:
1. A table of acceptance criteria and the reported device performance:
The document outlines comparisons between the subject device (K210276) and the predicate device (K171422), effectively serving as the acceptance criteria for substantial equivalence. The reported device performance is demonstrated by its compliance with the listed standards.
| Acceptance Criteria (Common to Subject & Predicate) | Reported Device Performance (K210276) |
|---|---|
| General Characteristics | |
| Product Code: LZA | LZA |
| Regulation No: 21CFR880.6250 | 21CFR880.6250 |
| Class: I | I |
| Intended Use: Medical purposes; worn on examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered/Powered free: Powdered free | Powdered free |
| Design Feature: Ambidextrous | Ambidextrous |
| Labeling Information: Single-use indication, powder free, device color, device name, glove size and quantity | Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Blue, Non-Sterile |
| Dimensions (Compliance with ASTM D6319-19) | |
| Length, mm: 230 min (for predicate) | 230 mm (S, M, L, XL) with ±10 tolerance |
| Width, mm: 75, 85, 95, 105, 115 (for predicate) with ±5 tolerance | 85 (S), 95 (M), 110 (L), 115 (XL) with ±10 tolerance |
| Thickness, mm: Finger 0.05 min | 0.05 min |
| Thickness, mm: Palm 0.05 min | 0.05 min |
| Physical Properties | |
| Before Aging: Tensile Strength 14MPa, min | 14MPa, min |
| Before Aging: Ultimate Elongation 500% min | 500% min |
| After Aging: Tensile Strength 14MPa, min | 14MPa, min |
| After Aging: Ultimate Elongation 400%min | 400%min |
| Freedom from Holes: Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5 |
| Powder Content: Meet requirements of ASTM D6124 | 0.01 mg per glove |
| Safety/Biocompatibility (Compliance with ISO 10993) | |
| Material: Nitrile | Nitrile |
| Irritation: Not an irritant (comply with ISO10993-10) | Not an irritant (under the conditions of the study) |
| Sensitization: Not a sensitizer (comply with ISO10993-10) | Not a sensitizer (under conditions of the study) |
| Cytotoxicity: Device extract is not cytotoxic (comply with ISO10993-5) | Device extract is not cytotoxic (under conditions of the study) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., number of gloves tested for tensile strength, holes, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The standards themselves (e.g., ASTM D6319, ASTM D5151) would define the required sample sizes for their respective tests, but these details are not present in this summary.
- Data Provenance: The tests were non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contracted lab. The manufacturer is Fujian Ercon Medical Management Co., Ltd. in China. The provenance is internal testing, not 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 not a study requiring expert readers or ground truth establishment in the context of interpreting medical images or data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is present or absent according to ASTM D5151 criteria).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an interpretive/diagnostic study, no adjudication method for human readers is relevant. The tests are laboratory measurements.
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 physical medical device (gloves), not an AI/ML diagnostic aid. There were no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective measurements and compliance with industry standards (e.g., ASTM D6319-19 for glove specifications, ASTM D5151-19 for holes, ISO 10993 for biocompatibility). It is based on pre-defined engineering specifications and test protocols.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
In summary, the provided document details the regulatory submission for a physical medical device, not an AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML study design are not applicable. The device's acceptance is based on non-clinical performance testing confirming its compliance with recognized standards and substantial equivalence to a legally marketed predicate 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.