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510(k) Data Aggregation
(153 days)
Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black Color, 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 for Medical Application. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large.
The provided text describes the acceptance criteria and the study that proves the device, Synthetic Polymer Glove - Polyethylene (Black), meets these criteria. The device is a non-sterile, disposable examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|
| Sterility | - | Non-sterile (Small, Medium, Large, X Large, XX Large) | - |
| Freedom from hole (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Pass (for all sizes) | Pass |
| Overall Length (mm) | Min 230mm | Small: 261.53, Medium: 260.1, Large: 260.08, X-Large: 259.8, XX-Large: 268.5 | Pass |
| Width (±10 mm) | Small: 80, Medium: 95, Large: 110, X-large: 120, XX-Large: 130 | Small: 86.30, Medium: 99.4, Large: 115.23, X-Large: 123.54, XX-Large: 134.5 | Pass |
| Thickness at Palm (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Thickness at Fingertip (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Physical Properties - Before Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 18.6, Medium: 17.45, Large: 18.53, X Large: 17.4, XX Large: 18.69 | Pass |
| - Ultimate Elongation (%) | 500% min | Small: 653.43, Medium: 673.5, Large: 689.15, X Large: 636.56, XX Large: 645.83 | Pass |
| Physical Properties - After Accelerated Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 17.8, Medium: 18.13, Large: 18.61, X Large: 18.3, XX Large: 18.34 | Pass |
| - Ultimate Elongation (%) | 400% min | Small: 645.18, Medium: 680.2, Large: 686.15, X Large: 614.58, XX Large: 636.87 | Pass |
| Powder-free Residue (ASTM D6124-06) | < 2.0 mg per glove | Not detected (for all sizes) | Pass |
| Test for In vitro cytotoxicity (ISO 10993-5) | Non-Cytotoxic | (Implicitly tested and meets criteria) | Pass |
| Test for irritation and Skin Sensitization (ISO 10993-10) | Non-Skin Sensitized | (Implicitly tested and meets criteria) | Pass |
| Tests for irritation (ISO 10993-23) | Non-Irritant | (Implicitly tested and meets criteria) | Pass |
2. Sample size used for the test set and the data provenance
The sample size is specified as "Avg. value of 13 pcs" for the dimensional and physical properties tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided document, but it is implied to be from the manufacturer's internal testing as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests relate to the physical and chemical properties of the glove, not a diagnostic or interpretive task requiring expert consensus on a "ground truth" derived from patient data. The "ground truth" here is the adherence to established ASTM and ISO standards for medical gloves.
4. Adjudication method for the test set
This is not applicable as the tests are objective measurements and laboratory analyses against predefined standards. There is no interpretive "test set" requiring adjudication by multiple readers/experts.
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
This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an examination glove, not an algorithm or software.
7. The type of ground truth used
The ground truth for the device's performance is established by objective measurements and laboratory analyses against internationally recognized standards for medical examination gloves. Specifically, the standards referenced are:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) - for mechanical properties and dimensions.
- ASTM D5151-19 - for freedom from holes.
- ASTM D6124-06 - for powder residue.
- ISO 10993-5:2009 - for in vitro cytotoxicity.
- ISO 10993-10:2021 - for skin sensitization.
- ISO 10993-23:2021 - for irritation.
8. The sample size for the training set
This is not applicable. The device is a physical product (glove) and does not involve machine learning or AI models that require training sets.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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