(33 days)
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance of "ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES." This is a Class I medical device (examination gloves), and the study conducted focuses on demonstrating its physical and chemical properties meet established standards, rather than evaluating an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements pertaining to AI studies (like MRMC, ground truth establishment for AI, expert qualifications, adjudication methods, training/test set sizes for AI algorithms) are not applicable to this type of device and study.
Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Dimension | X-Small: 70 mm +/- 10 mm (width) | X-Small: 70 - 75 mm (width) |
| Small: 80 mm +/- 10 mm (width) | Small: 80 - 85 mm (width) | |
| Medium: 95 mm +/- 10 mm (width) | Medium: 90 - 97 mm (width) | |
| Large: 111 mm +/- 10 mm (width) | Large: 105 - 111 mm (width) | |
| Length (all sizes): 230 mm minimum | Length: 242 mm | |
| Thickness - Finger: 0.08 mm min | Thickness - Finger: 0.08 mm min | |
| Thickness - Palm: 0.08 mm min | Thickness - Palm: 0.08 mm min | |
| Physical Properties | Tensile Strength (Before Aging): 14.0 Mpa min (ASTM-D3578-95) | Tensile Strength (Before Aging): 21.0 Mpa |
| Ultimate Elongation (Before Aging): 700 % (ASTM-D3578-95) | Ultimate Elongation (Before Aging): 800% | |
| Tensile Strength (After Aging): 14.0 Mpa min (ASTM-D3578-95) | Tensile Strength (After Aging): 16.0 Mpa | |
| Ultimate Elongation (After Aging): 500% (ASTM-D3578-95) | Ultimate Elongation (After Aging): 750% | |
| Water Tight Test | FDA/ASTM requirements for latex exam gloves of 4.0% AQL (Acceptable Quality Limit) | Batch 9903031019 (X-Small): 0 leaks |
| Batch 9903222024 (Small): 2 leaks | ||
| Batch 9904011027 (Medium): 0 leaks | ||
| Batch 9903162023 (Large): Based on other batches, presumably also within AQL. | ||
| All stated to be "within the FDA/ ASTM requirements". | ||
| Biocompatibility | Not a primary irritant (Primary Dermal Irritation Test) | Not a primary irritant |
| Not a sensitiser (Skin Sensitization Study) | Not a sensitiser | |
| Residual Powder Content | 2 mg/glove max (ASTM D 6124-97, FDA internal requirement) | Range: 1.5-1.9 mg/glove; Mean: 1.7 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.