(118 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state. The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.
The provided document is a 510(k) summary for Nitrile Powder Free Examination Gloves and Chemotherapy Nitrile Powder Free Examination Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Crucially, this document is for a Class I medical device (gloves) and explicitly states that "Clinical data is not required for marketing clearance of patient examination gloves." Therefore, there are no acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance related to an AI/ML device as none of this applies to the product described.
Instead, the document focuses on demonstrating that the gloves meet established performance standards for physical properties, barrier integrity, and biocompatibility.
Here's an analysis based on the information provided, specifically highlighting why the requested AI/ML-related information is absent and what was evaluated:
1. A table of acceptance criteria and the reported device performance
The document provides tables of non-clinical tests and their requirements, which serve as the acceptance criteria for these physical and chemical properties.
| Acceptance Criteria (Standard & Test) | Reported Device Performance (Summary) |
|---|---|
| ASTM D5151 Watertight Test (Freedom from Holes) | Pass Inspection Level G1, AQL 2.5 |
| ASTM D6319 Dimensions | Met requirements for Length (XS: min 220mm, S: min 220mm, M: min 230mm, L: min 230mm, XL: min 230mm, XXL: min 230mm); Palm Width (XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm); Thickness (Finger: min 0.05mm, Palm: min 0.05mm) |
| ASTM D6319 Physical Properties (Before Aging) | Tensile strength: min 14MPa; Ultimate elongation: min 500% |
| ASTM D6319 Physical Properties (After Aging) | Tensile strength: min 14MPa; Ultimate elongation: min 400% |
| ASTM D6124 Powder Amount | Residual powder 240 min, etc.). |
| ISO 10993-10 Biological Evaluation (Irritation and Skin Sensitization) | Passed primary skin irritation test and dermal sensitization test (Conclusion: Not an irritant and not a skin sensitizer). |
| ISO 10993-11 Biological Evaluation (Systemic Toxicity) | Passed systemic toxicity test (Conclusion: Considered non-toxic). |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many gloves were tested for watertightness, or how many samples for biocompatibility). The tests are standardized (ASTM, ISO), meaning they have established sample size requirements for their methodologies, but the specific numbers are not presented in this summary.
Data provenance: The tests were performed by the manufacturer (KL-Kepong Rubber Products Sdn. Bhd. in Malaysia) or accredited labs they contracted. The data is prospective, generated specifically for this submission.
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 an AI/ML device; therefore, there is no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The ground truth for these device properties is based on adherence to established international (ISO) and national (ASTM) standards and laboratory testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no subjective interpretation or diagnostic outcome to adjudicate for this type of device. The tests are objective and quantitative measurements against predefined specifications.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is objective and defined by established industry and regulatory standards for physical properties (e.g., dimensional measurements, tensile strength, elongation, freedom from holes, residual powder) and chemical resistance/biocompatibility via standardized testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ISO 10993 for biocompatibility).
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. This is not an AI/ML 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.