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510(k) Data Aggregation
(234 days)
A non-sterile powder free 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. The device is for over-the-counter use.
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.
The provided document is an FDA 510(k) summary for a medical device (Non-sterile Powder Free Nitrile Examination Gloves). It does not describe an AI/ML-driven medical device, nor does it involve image analysis, expert-based ground truth, or MRMC studies. Therefore, many of the requested elements for describing a study proving an AI/ML device meets acceptance criteria are not applicable.
However, I can extract the relevant "acceptance criteria" (performance specifications) and the "study that proves the device meets the acceptance criteria" (non-clinical performance tests) from the document as it pertains to this specific device.
Here's the information based on the provided document:
Device: Non-sterile Powder Free Nitrile Examination Gloves (K210990)
Device Type: Patient Examination Glove (Class I, reserved)
Intended Use: Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use.
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Dimensions | ASTM D6319-19 | Overall Length (mm): Min 230mmWidth (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min 0.05 mmThickness at Finger Tip (mm): Min 0.05 mm | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Physical properties | ASTM D6319-19 | Before Aging:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 500minAfter Aging at 70°C for 168 hrs @ 100°C for 22 hrs:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 400min | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Freedom from pinholes | ASTM D6319-19 | AQL 2.5 (Inspection Level G-1) | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | < 2.0 mg/pc | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 | Non-irritant | "test article was a non-irritant." | Similar to Predicate |
| Biocompatibility (Dermal Sensitization Assay) | ISO 10993-10 | Non-sensitizer | "test article was a non-sensitizer." | Similar to Predicate |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 | Not explicitly stated as a numerical criterion, but the predicate did not perform this test. The subject device showed "cytotoxic at 100% after an exposure period of 48 hours, non-cytotoxic at 10%". This difference was addressed by the FDA. | Test found cytotoxic at 100% after 48 hrs, non-cytotoxic at 10%. | Different from Predicate (predicate didn't test) |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 | Not induce systemic toxicity | "Not induce systemic toxicity" | Similar to Predicate |
2. Sample sized used for the test set and the data provenance
The document refers to standard test methods (e.g., ASTM D6319-19, ASTM D5151-19, ISO 28590:2017 for sampling). These standards specify the sample sizes for tests like AQL inspections for pinholes. For example, ASTM D5151-19, "Standard Test Method for Detection of Holes in Medical Gloves," would define the process for testing pinholes using an AQL (Acceptable Quality Limit) of 2.5. ISO 28590:2017 is explicitly mentioned as a "Sampling Procedure for Inspection by Attributes."
- Sample Size: Not explicitly stated as a single number, but implied to follow the sampling plans within the referenced standards (e.g., AQL 2.5, Inspection Level G-1 for pinholes).
- Data Provenance: The tests are non-clinical (laboratory tests on physical samples/materials). The manufacturer is Rubberex Alliance Sdn Bhd, based in Ipoh, Perak, Malaysia. The testing would have been conducted by the manufacturer or a contracted lab. The data is prospective as it describes the testing performed on the device samples to support the 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 for a physical medical device (gloves), not an AI/ML device that requires expert-established ground truth for image interpretation or similar. The "ground truth" for these tests are objective measurements and compliance with chemical/physical standards.
4. Adjudication method for the test set
Not applicable. See point 3.
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. The "performance" is the physical properties of the glove itself.
7. The type of ground truth used
The "ground truth" is established by:
- Objective Measurement: Adherence to specified dimensions (length, width, thickness), tensile strength, and elongation through standardized testing methods.
- Chemical Analysis: Measurement of residual powder.
- Biological Testing: Standardized in-vitro and in-vivo biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) as defined by ISO 10993 series.
- Statistical Sampling: AQL (Acceptable Quality Limit) tests for defects like pinholes, using established statistical sampling procedures (ISO 28590:2017).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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