(134 days)
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
This document is a 510(k) Pre-Market Notification for the Nitra-Touch™ examination gloves. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | ASTM D 3578 (except for ultimate elongation) | Meets ASTM D 3578 (except for ultimate elongation). Explicitly states: "Original Ultimate Elongation 500% minimum" and "Aged Ultimate Elongation 400% minimum" - these values are variations from ASTM D 3578 but are presented as met specifications under Attachment II. |
| Freedom from holes | ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Described test in Attachment V (Not more than 2 mg residue by mass) | Meets described test in Attachment V |
| Tensile Strength | Vinyl = 10.5 MPa (for comparison) | Nitra-Touch™ = 17.1 MPa (60% higher than vinyl) |
| Puncture Resistance | ASTM D 120-87 (for comparison) - specifically mentions "Vinyl (Synthetic) = 184 lbf/in" and "Blue Nitrile = 929 lbf/in" for context. | Nitra-Touch™ = 1625 lbf/in (eight times greater than vinyl and nearly twice that of competitive nitrile gloves) |
| Glutaraldehyde Resistance | ASTM F739-91 (Permeation Rate = 480 minutes) | Permeation Rate = 480 minutes. The document states "Nitrile film provides excellent chemical resistance to glutaraldehyde" and references ASTM T F739-91, with "Source: TRI/Environmental, Inc." for the permeation data. |
| Biocompatibility (Primary Skin Irritation) | Not explicitly stated as a standard, but implies a pass/fail criteria from a common test. | Passes (in Rabbits) |
| Biocompatibility (Guinea Pig Sensitization) | Not explicitly stated as a standard, but implies a pass/fail criteria from a common test. | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" and rather references compliance with existing ASTM standards and internal tests. Information regarding sample sizes for each specific test (e.g., freedom from holes, tensile strength, puncture resistance, biocompatibility) is not provided. The data provenance is implied to be from internal testing conducted by Ansell Edmont Industrial, Inc. and potentially third-party labs like TRI/Environmental, Inc. for the glutaraldehyde resistance. The data is presented as retrospective as it's being submitted for current product clearance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for the performance characteristics of medical examination gloves is established by the specified ASTM (American Society for Testing and Materials) standards and FDA requirements. The tests are physical and chemical measurements against these quantitative standards, not subjective assessments requiring expert consensus for ground truth.
4. Adjudication method for the test set
This is not applicable. As stated above, the performance is measured against established quantitative standards, not through subjective interpretation requiring 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
There is no MRMC comparative effectiveness study mentioned or implied. This device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating the Nitra-Touch™ examination gloves is based on established industry standards (ASTM) and regulatory requirements (FDA) for medical examination gloves. These standards define specific physical and chemical properties (e.g., dimensions, strength, freedom from holes, biocompatibility) with quantitative pass/fail criteria.
8. The sample size for the training set
This is not applicable. This is a submission for a physical medical device (gloves) and does not involve a "training set" in the context of machine learning or AI models. The manufacturing processes and quality control would involve statistical sampling, but this is distinct from a "training set" for an algorithm.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.