(62 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
The provided document is a 510(k) summary for "NON-STERILE POWDER FREE GREEN LATEX EXAM GLOVES WITH ALOE VERA & VITAMINE" and does not describe an AI medical device. The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically relevant for AI/ML-based diagnostic or prognostic devices, not for a medical glove.
Therefore, I cannot provide the information requested in the format of the prompt, as it is not applicable to the given document.
The document describes the performance characteristics of medical gloves against ASTM standards and FDA requirements. These are not "AI device performance metrics" in the sense of the prompt.
However, I can extract the closest analogous information from the document as it relates to the glove's performance against established criteria:
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (ASTM D3578-00 or FDA) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimensions (Width) | ||
| X-Small | 70 mm +/- 10 mm | 70 - 75 mm |
| Small | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium | 95 mm +/- 10 mm | 90 - 97 mm |
| Large | 111 mm +/- 10 mm | 105 - 111 mm |
| Dimensions (Length) | 230 mm minimum | 252 mm |
| Thickness | ||
| Finger | 0.08 mm min | 0.08 mm min |
| Palm | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | ||
| X-Small | 14.0 Mpa | 25.8 Mpa |
| Small | 14.0 Mpa | 27.8 Mpa |
| Medium | 14.0 Mpa | 27.9 Mpa |
| Large | 14.0 Mpa | 27.1 Mpa |
| Tensile Strength (After Aging) | ||
| X-Small | 14.0 Mpa | 24.1 Mpa |
| Small | 14.0 Mpa | 27.0 Mpa |
| Medium | 14.0 Mpa | 28.7 Mpa |
| Large | 14.0 Mpa | 25.6 Mpa |
| Ultimate Elongation (Before Aging) | ||
| X-Small | 700 % | 830 % |
| Small | 700 % | 920 % |
| Medium | 700 % | 900 % |
| Large | 700 % | 950 % |
| Ultimate Elongation (After Aging) | ||
| X-Small | 500 % | 950 % |
| Small | 500 % | 910 % |
| Medium | 500 % | 910 % |
| Large | 500 % | 910 % |
| Water Leak Test | 2.5% AQL (Acceptance Quality Limit) | Leaked: X-Small (1), Small (0), Medium (1), Large (2) for UN-AGED. X-Small (0), Small (1), Medium (2), Large (0) for AGED. All within 2.5% AQL. |
| Biocompatibility | Passed tests for examination gloves | Passed |
| Residual Powder Content | 2 mg/glove max (FDA Internal Requirement) | Range: 0.5-0.8 mg/glove; Mean: 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level |
§ 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.