(194 days)
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to provent contamination between patient and examiner. Gloves with labeled protein are sultable In situations where health care worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity.
Patient examination gloves are made with intect netural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner.
The provided text describes a 510(k) submission for a medical device: "POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) Non-Sterile Patient Examination Glove." The submission aims to demonstrate that this new device is substantially equivalent to existing predicate devices.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Predicate Device Performance | Proposed Device Performance |
|---|---|---|
| Physical Dimensions | ASTM (Passes) | ASTM (Passes) |
| Physical Properties | ASTM (Passes) | ASTM (Passes) |
| Water Tightness | ASTM (Passes) | ASTM (Passes) |
| Rabbit Skin Irritation | Passes (#s 1 and 2) | Passes |
| Guinea Pig Sensitization | Passes (#s 1 and 2) | Passes |
| Modified Draize Repeat Insult Patch Test on Human Subjects | Passed (#2) - 200 subjects | Passes - 300 subjects |
| Hypoallergenic Labeling | Yes (Predicate #2) | Yes |
| Powder-Free | Yes (Predicate #1) | Yes |
| Labeled with Protein Content | Yes (Predicate #1) | Yes |
| Intended Use (Barrier to body fluids/bloodborne pathogens) | Yes | Yes |
| Intended Use (Suitable for allergic sensitivity) | Yes (Predicate #2) | Yes |
| Intended Use (Powder-free situations) | Yes (Predicate #1) | Yes |
2. Sample Sizes Used for the Test Set and Data Provenance
- Human Subjects for Modified Draize Repeat Insult Patch Test:
- Proposed Device: 300 human subjects.
- Predicate Device #2: 200 human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the human subject tests. It mentions "About three hundred persons at three different locations completed the study," implying a prospective clinical test. For the physical and pre-clinical tests, the data provenance is implied to be from laboratory testing. It is a prospective clinical test for the human patch test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts involved in establishing the ground truth for the Modified Draize Repeat Insult Patch Test. It only states that the "study" was completed, implying observation and evaluation by qualified personnel, but the specific roles and qualifications are not detailed. For the ASTM tests and animal studies, these are standardized tests, and the "ground truth" is established by adherence to the protocol and the resulting measurements/observations, typically overseen by laboratory technicians and scientists.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (like 2+1, 3+1) for the human subject tests or any other tests. The "Passed" designation for the Modified Draize test implies a clear outcome based on predefined criteria for skin sensitization.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to evaluate diagnostic imaging devices where human readers interpret results, and the document describes a glove, not an imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the device described. The device is a physical medical glove, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical Dimensions, Physical Properties, Water Tightness: The ground truth is based on standardized ASTM (American Society for Testing and Materials) specifications and measurement outcomes.
- Rabbit Skin Irritation & Guinea Pig Sensitization: The ground truth is based on standardized animal study protocols and observations of physiological reactions.
- Modified Draize Repeat Insult Patch Test on Human Subjects: The ground truth is established through clinical observation of human subjects for signs of sensitization over a specified period, following a standardized protocol. This could be considered a form of clinical outcome data related to skin reactions.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. This terminology is usually associated with AI/machine learning models. For a physical device like a glove, the development process involves iterative design and testing, but not typically a distinct "training set" as defined for AI. The manufacturing process is described as a "5 step washing/leaching process," which is identical to the predicate device, implying established manufacturing parameters rather than a data-driven training set.
9. How the Ground Truth for the Training Set was Established
As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. However, the manufacturing process, which could be seen as the "development" or "training" of the product, is based on the proven "5 step washing/leaching process" of the predicate device, implying that the "ground truth" for this process was established through prior successful manufacturing and performance of the 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.