(39 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.
The Powder Free Non Sterile Examination gloves with a protein label claim are formulated using in-house compounded latex and offered non-sterile.
This document describes the safety and effectiveness of the Allegiance Non-Sterile Powder-Free Latex Examination Glove With Protein Labeling Claim.
Acceptance Criteria and Reported Device Performance:
The device's performance is primarily evaluated against the ASTM Standard Specification for Rubber Examination Gloves D3578-95 and FDA regulations (21 CFR §800.20 and 21 CFR 807.97).
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Primary Skin Irritation (ISO 10993-1 / USP XXIII) | Acceptable criterion for primary skin irritation. (Passed) |
| Intracutaneous Reactivity (ISO 10993-1 / USP XXIII) | Glove does not elicit irritation following intradermal injection of extracts. |
| Skin Sensitization (Kligman Maximization method) | Glove does not display sensitization potential to produce skin sensitization. |
| Physical Characteristics (ASTM D3578-95) | |
| Ultimate Elongation & Tensile Strength | Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-95. |
| Barrier Defects (using FDA 1000 mL test method, 21 CFR §800.20) | Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-95, AQL=4.0. |
| Protein Label Claim (ASTM 5712-95) | |
| Low protein claim designation (50 mcg or less total water extractable protein per gram per glove) | Gloves meet requirements for a low protein claim designation of 50 micrograms or less of total water extractable protein per gram per glove using the ASTM Lowry test method (ASTM 5712-95). |
| Powder-Free Designation | |
| Powder level (below 2mg/glove cornstarch using vacuum filtration method + negative iodine test) | Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch. |
| Dimensions (Medium Glove) | |
| Length (min. cm) | min. 23.0 |
| Width (cm) | 9.8-10.0 (reported); ASTM D3578-95 value not specified for comparison |
| Thickness: Cuff (min. mm) | 0.13 mm (min.) |
| Thickness: Palm (min. mm) | 0.19 mm (min.) |
| Thickness: Finger (min. mm) | 0.20 mm (min.) |
Study Details:
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for barrier defects, number of subjects for skin irritation tests).
- The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The manufacturing and chlorination facilities are located in Malaysia, suggesting tests might have been conducted there or on products from those facilities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document as it pertains to medical device testing against established standards (ASTM, ISO, FDA regulations), rather than diagnostic algorithm evaluation requiring expert consensus on images/data. The "ground truth" is defined by the objective measurement techniques and criteria outlined in the referenced standards.
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Adjudication method for the test set:
- Not applicable in this context. The evaluation is based on objective measurements against predefined thresholds in established standards.
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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 a medical device (examination glove), not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- The ground truth is based on established industry standards and regulatory requirements, including:
- ASTM Standard Specification for Rubber Examination Gloves D3578-95
- ISO 10993-1 / USP XXIII (for biocompatibility)
- 21 CFR §800.20 (FDA 1000 mL leak test method)
- ASTM 5712-95 (for protein level determination)
- The ground truth is based on established industry standards and regulatory requirements, including:
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.