(212 days)
A powder-free patient examination gloves 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. The device is for over-the-counter use.
RS BLACK Black Medical Examination Nitrile gloves (powder free) 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 from nitrile latex compound, black colour and powder free.
The document describes the acceptance criteria and performance of "RS BLACK Black Nitrile Medical Examination Gloves (Powder Free)".
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance (RS BLACK Black Nitrile Medical Examination Gloves Powder Free) |
|---|---|---|
| Product Code | LZA | LZA |
| Intended use | Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. For over-the-counter use. | Matches standard intended use. |
| Material use | Nitrile latex compound | Nitrile latex compound |
| Colour | N/A (Predicate is Blue) | Black |
| Dimensions | 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 (ISO 10993-10:2010(E)) | Passes |
| Biocompatibility (Dermal Sensitization) | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (ISO 10993-10:2010(E)) | Passes |
2. Sample size used for the test set and the data provenance:
The document doesn't explicitly state the sample sizes for the tests conducted to prove compliance with ASTM D 6319-10 or biocompatibility. The country of origin of the device manufacturer is Malaysia. The data appears to be prospective testing conducted for regulatory submission, as it describes the properties of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests refer to compliance with established standards (ASTM D 6319-10, ISO 10993-10:2010(E)), which typically involve standardized testing protocols and measurements rather than expert consensus on individual cases.
4. Adjudication method for the test set:
Not applicable. The tests are against objective standards (e.g., physical properties, pinhole incidence, biocompatibility).
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 device is a medical examination glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical examination glove, not an algorithm.
7. The type of ground truth used:
The ground truth used is based on established industry standards and regulatory requirements. For physical properties (dimensions, tensile strength, freedom from pinholes, powder residue), the ground truth is defined by the specifications outlined in ASTM D 6319-10. For biocompatibility (Primary Skin Irritation Test and Dermal Sensitization), the ground truth is defined by the pass/fail criteria within ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this 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.