(15 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 nitrile patient examination glove 80LZA, powder free and meeting all the requirements of ASTM Class Finance partierd Specification for nitrile Examination Gloves for Medical Application, except for the elongation at break parameter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the POWDER FREE GREEN COLOR SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES:
1. Table of Acceptance Criteria and Reported Device Performance:
The device (SGMP's) is compared against the ASTM D6319-00a standard (except for elongation at break, for which SGMP's performance is listed directly).
| Acceptance Criteria Category | Specific Parameter | ASTM D6319-00a (Acceptance Criteria) | SGMP's Reported Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Dimension | X-Small Width | 70 mm +/- 10 mm | 70 - 75 mm | Yes |
| Small Width | 80 mm +/- 10mm | 80 - 85 mm | Yes | |
| Medium Width | 95 mm +/- 10mm | 90 - 97 mm | Yes | |
| Large Width | 111mm +/- 10mm | 105 - 111 mm | Yes | |
| Length (all sizes) | 230 mm minimum | 242mm | Yes | |
| Thickness - Finger | 0.08mm min | 0.08 mm min | Yes | |
| Thickness - Palm | 0.08mm min | 0.08 mm min | Yes | |
| Physical Properties | Tensile Strength (Before Aging) | 14.0 MPa | X-Small: 16.5 MPa | |
| Small: 16.0 MPa | ||||
| Medium: 15.3 MPa | ||||
| Large: 17.6 MPa | Yes (Exceeds) | |||
| Tensile Strength (After Aging) | 14.0 MPa | X-Small: 17.1 MPa | ||
| Small: 18.0 MPa | ||||
| Medium: 17.5 MPa | ||||
| Large: 19.4 MPa | Yes (Exceeds) | |||
| Ultimate Elongation (Before Aging) | 500 % | X-Small: 650 % | ||
| Small: 680 % | ||||
| Medium: 700 % | ||||
| Large: 670 % | Yes (Exceeds) | |||
| Ultimate Elongation (After Aging) | 400 % | X-Small: 680 % | ||
| Small: 670 % | ||||
| Medium: 690 % | ||||
| Large: 720 % | Yes (Exceeds) | |||
| Water Tight Test | AQL for Leaks | 2.5% AQL (ASTM D3578-00) | UN-AGED: 1/125 (X-Small), 0/125 (Small), 2/125 (Medium), 1/125 (Large) | |
| AGED: 0/125 (X-Small), 1/125 (Small), 1/125 (Medium), 0/125 (Large) | Yes (All reported within 2.5% AQL) | |||
| Biocompatibility | Dermal Irritation | Not a dermal irritant | Not a dermal irritant | Yes |
| Skin Sensitization | Not a skin sensitizer | Not a skin sensitizer | Yes | |
| Residual Powder Content | Residual Powder Content | 2 mg/glove max | Range: 0.7-1.5mg/glove | |
| Mean: 1.05 mg/glove | Yes | |||
| Presence of Cornstarch | Negative | Negative | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Dimension, Tensile Strength, Ultimate Elongation, Residual Powder, Cornstarch: Not explicitly stated for each test, but the results are reported for "SGMP's" and indicate measurements across different sizes (X-Small, Small, Medium, Large) and under "Before Aging" and "After Aging" conditions. The specific number of gloves tested for each individual measurement (e.g., how many gloves were measured for X-Small tensile strength before aging) is not provided.
- Water Tight Test: 125 pieces of each size (X-Small, Small, Medium, Large) were tested for both un-aged and aged conditions. This totals 1000 gloves (4 sizes * 125 gloves/size * 2 aging conditions).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing conducted by "SGMP's" (the manufacturer) for submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a physical product (examination gloves), not an AI/imaging device that requires expert interpretation for ground truth. Therefore, the concepts of "experts" and their "qualifications" as typically applied to medical image analysis or diagnostic AI studies are not relevant here. The ground truth for these tests is established by physical measurement against established laboratory standards (e.g., ASTM D6319-00a, ASTM D3578-00, ASTM D6124-00, biocompatibility testing protocols).
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of expert opinions or interpretations. The tests are based on objective physical and chemical properties measured against defined 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:
Not applicable. This is not an AI-assisted device, nor does it involve human "readers" or case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used:
The ground truth used is based on established industry standards and laboratory testing protocols. Specifically:
- ASTM-D6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application for dimensions, tensile strength, and ultimate elongation.
- FDA specified 1,000 ml water leak test, evaluated against ASTM D3578-00 requirements for examination gloves (2.5% AQL).
- Biocompatibility tests (dermal irritation and skin sensitizer testing).
- ASTM D 6124-00 for Residual Powder Content.
- Tests for the Presence of Cornstarch.
8. The sample size for the training set:
Not applicable. There is no training set as this is a physical product, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
§ 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.