(249 days)
A 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.
Orange Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, orange colour, powder free and non sterile.
This document is a 510(k) Pre-market Notification for a medical device: "RS Orange Nitrile Medical Examination Gloves (Powder Free)". This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might.
Therefore, the requested information about clinical study design, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, and standalone algorithm performance does not directly apply to this type of submission. The "study" here refers to non-clinical performance testing and biocompatibility assessments against established standards.
Here's an interpretation of the document in the context of your request:
Acceptance Criteria and Device Performance
The device demonstrates performance against recognized standards, specifically ASTM D6319-10 for physical characteristics and FDA-recommended biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Device Performance (RS Orange Nitrile Medical Examination Gloves Powder Free) |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pinholes | ASTM D 6319-10 | Meets |
| Powder-Free | ASTM D 6319-10 | Meets |
| Biocompatibility | ||
| Primary Skin Irritation Test | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay | ISO 10993-10:2010(E) | Under the conditions of this study, the test article was a non-sensitizer. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the physical and biocompatibility tests. These are typically standard tests performed on batches of gloves according to the relevant ASTM and ISO standards. The data provenance would be from laboratory testing of the manufactured gloves. The document originates from Malaysia (Riverstone Resources Sdn.Bhd.). The testing would be considered prospective in the sense that the tests were performed on the device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here. The "ground truth" for glove performance is established by the specified standards (ASTM D 6319-10) and regulatory guidelines for biocompatibility. The results are objective measurements or categorical assessments (e.g., non-irritant, non-sensitizer) from laboratory testing, not subjective expert judgment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Laboratory tests have defined methods for determining outcomes, rather than requiring expert 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 for a physical medical examination glove, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on:
- Standard Specifications: Meeting the chemical and physical property requirements defined by ASTM D 6319-10.
- Biocompatibility Standards: Results from established laboratory tests (Primary Skin Irritation Test, Dermal Sensitization Assay) based on the Consumer Product Safety Commission guidelines and ISO 10993-10:2010(E).
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not a machine learning model.
Summary of the "Study" (Performance Testing):
The "study" for this device consists of non-clinical performance testing and biocompatibility assessments to demonstrate that the RS Orange Nitrile Medical Examination Gloves (Powder Free) meet the established requirements of ASTM D 6319-10 for physical properties (dimensions, physical properties, freedom from pinholes, powder-free status) and specific biocompatibility standards (Primary Skin Irritation Test and Dermal Sensitization Assay). The results consistently demonstrate that the device "Meets" the ASTM standard and was found to be a "non-irritant" and "non-sensitizer" in the biocompatibility tests. This data forms the basis for the conclusion that the device is substantially equivalent to the predicate devices and performs according to performance standards and FDA requirements.
§ 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.