(97 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)" by Ever Light Plastic Products Company, Ltd. It details the safety and effectiveness information for the device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on the ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application and ISO 10993-10 for biocompatibility.
| Characteristic | Standard/Acceptance Criteria | Device Performance (Subject Device) | Result of Comparison (to Predicate) | Conclusion (from Non-Clinical Tests) |
|---|---|---|---|---|
| Material | Vinyl (same as predicate) | Vinyl | Similar | N/A (inherent property) |
| Color | Yellow, White, Blue, Pink (same) | Yellow, White, Blue, Pink | Similar | N/A (inherent property) |
| Tensile Strength (Before aging) | ASTM D5250-06: 11 MPa minimum | 15.2-18.1 MPa | Similar (Predicate: 14.3-17.6 MPa) | Pass |
| Tensile Strength (After aging) | ASTM D5250-06: 11 MPa minimum | 14.6-17.4 MPa | Similar (Predicate: 13.3-16.8 MPa) | Pass |
| Ultimate Elongation (Before aging) | ASTM D5250-06: 300% minimum | 390-470% | Similar (Predicate: 380-429%) | Pass |
| Ultimate Elongation (After aging) | ASTM D5250-06: 300% minimum | 360-450% | Similar (Predicate: 370-401%) | Pass |
| Freedom from Pinholes | ASTM D5250-06: G-I, AQL 2.5 | 125 gloves sampled, 0 leaks | Similar (Predicate: 1 leak) | Pass |
| Overall Length (mm) | ASTM D5250-06: 230mm minimum | S: 232-245, M: 233-241, L: 236-243, XL: 234-242 | Similar (Predicate: 245-246mm) | Pass |
| Width (mm) | ASTM D5250-06: S:85±5, M:95±5, L:105±5, XL:115±5 | S: 87-88, M: 97-98, L: 107-108, XL: 118-119 | Similar (Predicate: S/86, M/96, L/106, XL/116) | Pass |
| Palm Thickness (mm) | ASTM D5250-06: 0.08mm minimum | 0.08mm | Similar (Predicate: 0.08-0.10mm) | Pass |
| Finger Thickness (mm) | ASTM D5250-06: 0.05mm minimum | 0.10-0.12mm | Similar (Predicate: 0.10-0.11mm) | Pass |
| Residual Powder | ASTM D5250-06: Not more than 2mg/glove | 0.16mg/glove | Similar (Predicate: 0.9mg/glove) | Pass |
| Primary Skin Irritation | ISO 10993-10: Not an irritant | Not an irritant | Similar (Predicate: Not an irritant) | Pass |
| Dermal Sensitization | ISO 10993-10: Not an irritant | Not an irritant | Similar (Predicate: Not an irritant) | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the total sample size for the "test set" in a sense that would be typically used for a machine learning model. Instead, it refers to specific sample sizes for particular physical tests:
- Pinhole Test: 125 gloves sampled (for both subject and predicate device performance comparison, and also for the actual testing results).
- Residual Powder: N=5 gloves.
- Other Physical Property Tests (Tensile Strength, Elongation, Dimensions): The inspection level for these tests is S-2, AQL 4.0. While this specifies the sampling plan, the exact number of units sampled for each lot/test is not explicitly given as a single number but is determined by the AQL (Acceptance Quality Limit) table itself.
Data Provenance: The document explicitly states the manufacturer's location as Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000. This indicates the country of origin of the data is China. The studies described are non-clinical (laboratory testing of physical and chemical properties) and appear to be prospective, performed specifically for this 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 to this type of device and submission. This is a medical device for which physical characteristics and biocompatibility are tested against established standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the way one would for diagnostic imaging or a qualitative assessment. The "ground truth" is the objective measurement of the device's properties against predefined quantitative and qualitative standards.
4. Adjudication Method for the Test Set
This information is not applicable. Since the evaluation is against objective, standardized measurements and criteria (e.g., MPa for tensile strength, % for elongation, AQL for pinholes), there's no need for an adjudication method by experts to resolve disagreements. The results are quantitative measurements or qualitative assessments against a defined standard (e.g., "not an irritant").
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 information is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an examination glove, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established consensus standards and objective measurements:
- ASTM D5250-06 (Reapproved 2011) for physical properties (tensile strength, elongation, pinholes, dimensions, residual powder).
- ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).
These standards represent a regulatory and scientific consensus on acceptable performance for medical examination gloves.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML device that requires a "training set." The device performance is assessed through direct physical and biocompatibility testing against predefined standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. There is no training set for this type of medical 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.