(76 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
The provided text describes the acceptance criteria and test results for "Powder-Free Latex Examination Gloves with Protein & Chemotherapy Labeling Claim."
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Implicit: Does not display irritation potential) | Glove does not display irritation potential. |
| Sensitization Potential (Guinea Pig Max) | (Implicit: Does not display sensitization potential) | Glove does not display sensitization potential. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements per ASTM D3578-00. | Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00. |
| Barrier Defects | Meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-00, AQL=2.5. | Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-00, AQL=2.5. |
| Powder Level | Meets requirements for "Powder Free" designation per ASTM D 3578-00. | Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00. |
| Protein Labeling Claim | 50 microgram or less of total water extractable protein per gram of glove per ASTM 5712-95. | Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-95). |
| Chemotherapy Drug Permeation (Intended Use) | Tested for use with chemotherapy drugs using ASTM F 739-99a. | These gloves have been tested for use with chemotherapy drugs using ASTM F 739-99a. (Note: The document states that it was tested but does not explicitly provide a pass/fail criteria or specific permeation results in the summary of test results section). |
2. Sample sizes 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 test or the data provenance (e.g., country of origin, retrospective/prospective). It refers to specific ASTM standards (D3578-00, 5712-95, F 739-99a) and 21 CFR §800.20, which would typically define the sampling plans. The manufacturer is Allegiance Healthcare Sdn. Bhd. located in Penang, West Malaysia, suggesting the data may originate from Malaysia or internal corporate testing.
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 section is not applicable to this device. The tests described are laboratory performance tests for physical properties and chemical composition of gloves, not diagnostic tests requiring expert interpretation for ground truth. The "ground truth" here is objective measurement against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to this device, as adjudication is typically relevant for subjective expert assessments, which are not involved in these performance tests. The evaluation is based on meeting predefined objective standards.
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 section is not applicable to this device. This is a medical device (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies or AI involvement are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable to this device. As mentioned, this is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance tests is based on objective measurement against established industry standards and regulations. These include:
- ASTM D3578-00 (Standard Specification for Rubber Examination Gloves)
- 21 CFR §800.20 (Barriers)
- ASTM 5712-95 (Standard Test Method for the Total Protein in Natural Rubber Latex and its Concentrates by the Lowry Method)
- ASTM F 739-99a (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact)
8. The sample size for the training set
This section is not applicable to this device. There is no concept of a "training set" for physical test results of examination gloves. The manufacturing process and quality control would involve ongoing testing, but not in the sense of a training set for an AI model.
9. How the ground truth for the training set was established
This section is not applicable to this device for the same reasons as (8).
§ 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.