(157 days)
A 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.
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides two tables that fulfill this request:
- A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
- A "Non-clinical Testing Summary" table on page 6.
Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.
| Characteristic / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LYY | LYY |
| Intended Use | Prevent contamination between patient and examiner. | Same as predicate. |
| Classification | Class I | Class I |
| Raw Rubber Material | Natural Rubber Latex | Natural Rubber Latex |
| Color | No color pigment added. Natural White | No color pigment added. Natural White |
| Overall Length Minimum | 230mm (Predicate: Meet ASTM D3578-05) | Average: 247 mm |
| Width (S, M, L) | S: 75-95mm; M: 85-105mm; L: 100-120mm | S: 85mm; M: 96 mm; L: 104 mm |
| Palm Thickness (Minimum) | 0.08mm | Average: 0.122 mm |
| Finger Thickness (Minimum) | 0.08mm | Average: 0.156 mm |
| Tensile Strength (before age) | Minimum 18 MPa | Average: 26.17MPa |
| Tensile Strength (After Age) | Minimum 14 MPa | Average: 24.82MPa |
| Stress at 500% Elongation | Maximum 5.5 MPa | 4.99 MPa |
| Ultimate Elongation (before age) | Minimum 500% | Average: 759.85% |
| Ultimate Elongation (after age) | Minimum 400% | Average: 678.62% |
| Freedom of Holes | Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 (Also Complied with ASTM D5151-06) |
| Residual powder test | Less than 2mg/glove | S: 0.43 mg/glove; M: 0.31 mg/glove; L: 0.47 mg/glove (Complied with ASTM D6124-06) |
| Protein Testing | Less than 50 µg/dm2 | S, M, L sizes: Less than 50 µg/dm2 |
| Primary Skin Irritation | Not an irritant (ISO 10993-10:2010) | Not an irritant |
| Dermal Sensitization | Not a sensitizer (ISO 10993-10:2010) | Not a sensitizer |
| Acute Systemic Toxicity | No evidence of systemic toxicity (from extract) | No evidence of systemic toxicity |
| Overall Compliance | Various ASTM and ISO standards | Complied with relevant standards (ASTM D6124-06, ASTM D5151-06, ASTM D3578-19, ISO 10993-10:2010) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.
The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple 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
Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool or system that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product (medical glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:
- ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
- ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
- ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.
The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.
8. The sample size for the training set
Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.