(28 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.
Device beser patient examination gloves 80LYY, powder free and meeting all the requirements Class Plater parts of Specification for Latex Examination Gloves for Medical Application.
This request is about a medical device, but the provided text describes a "NON-STERILE POWDER FREE CHOCOLATE SCENTED LATEX EXAM GLOVES". This type of product is a medical device, but it is not an AI/ML powered device, so acceptance criteria and study information mentioned in the request are not applicable.
However, since there are acceptance criteria and study data on device performance, I will provide the information accordingly.
Acceptance Criteria and Device Performance for Powder-Free Chocolate Scented Latex Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-00 / FDA Internal Requirement) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension - 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 |
| Dimension - Length | 230 mm minimum (for all sizes) | 252 mm |
| Thickness - Finger | 0.08 mm min | 0.08 mm min |
| Thickness - Palm | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | 14.0 Mpa | X-Small: 27.5 Mpa |
| Small: 24.3 Mpa | ||
| Medium: 24.5 Mpa | ||
| Large: 24.7 Mpa | ||
| Tensile Strength (After Aging) | 14.0 Mpa | X-Small: 29.5 Mpa |
| Small: 19.5 Mpa | ||
| Medium: 23.6 Mpa | ||
| Large: 26.5 Mpa | ||
| Ultimate Elongation (Before Aging) | 700 % | X-Small: 850 % |
| Small: 810 % | ||
| Medium: 810 % | ||
| Large: 810 % | ||
| Ultimate Elongation (After Aging) | 500 % | X-Small: 930 % |
| Small: 790 % | ||
| Medium: 820 % | ||
| Large: 900 % | ||
| Water Tight Test (AQL) | 2.5% AQL (draft FDA/ASTM D3578-00) | Un-aged: Overall 4 leaks out of 500 (0.8%) |
| Aged: Overall 4 leaks out of 500 (0.8%) | ||
| Biocompatibility | Passed relevant tests for examination gloves | Passed tests for examination gloves |
| Residual Powder Content (ASTM D 6124-00) | 2 mg/glove max | Range: 0.8-1.6 mg/glove |
| Mean: 1.2 mg/glove | ||
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level (ASTM D 5712-99) |
§ 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.