(58 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners.
Private lebel-Nirile Examination Gloves Powder Free Blue and White Color : Patient Examination Gloves
The provided text describes the acceptance criteria and performance data for "Nitrile Examination Gloves Powder Free Blue and White Color" manufactured by PT. Berlian Glovindo.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance (Test Results as per ASTM D 3578-95) |
|---|---|
| Dimensions: | |
| Length (XS, S, M, L, XL) | 240 mm (all sizes) |
| Width (XS) | 111 mm |
| Thickness: | |
| Cuff (min) | 0.10 mm |
| Palm (min) | 0.10 mm |
| Finger Tip (min) | 0.10 mm |
| Physical Properties: | |
| Tensile Strength (Before Aging) | 14 Mpa (min.) |
| Tensile Strength (After Aging at 100ºC 22 hrs.) | 14 Mpa (min.) |
| Ultimate Elongation (Before Aging) | 700 % (min.) |
| Ultimate Elongation (After Aging at 100ºC 22 hrs.) | 500 % (min.) |
| Characteristic Related Defects Inspection (AQL Level): | |
| Visible defects (Stains, Lumps, Holes etc.) | S-4, 2.5 |
| Watertight Holes | S-4, 2.5 |
| Dimensions | S-2 |
| Physical Properties (Before and after aging) | S-2 |
| Other: | |
| Weight of residual powder in medium size gloves | 0.5 ± 0.2 mg |
| Bio-Compatibility | Meets FDA pin hole requirement. Meets labeling claim. |
The document states, "(6) Performance data is the same as mentioned immediately above," which indicates that the device met all the listed acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to ASTM D 3578-95 standards for testing. This is a standard specification for rubber examination gloves. While it specifies sampling methods and acceptable quality levels (AQLs) for inspection (e.g., S-4, 2.5 for visible defects and watertight holes; S-2 for dimensions and physical properties), it does not explicitly state the exact sample size used for the specific tests conducted by PT. Berlian Glovindo in this document. The sample sizes would have been determined by the application of the ASTM D 3578-95 standard and the specified AQL levels during the manufacturing and quality control process.
Data Provenance:
- Country of Origin: Indonesia (manufacturer: PT. Berlian Glovindo, located in Medan, Indonesia).
- Retrospective or Prospective: The testing described is part of the product's quality control and regulatory submission, implying it's prospective testing done to demonstrate compliance before market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish a "ground truth" in the clinical or interpretative sense. The ground truth for glove performance is established by objective measurements and standardized tests as defined by ASTM D 3578-95. The tests involve physical measurements (dimensions, tensile strength, elongation), visual inspection for defects, and water leak tests. Therefore, the "experts" would be qualified quality control personnel or laboratory technicians trained in performing these specific ASTM tests. The document does not specify their number or qualifications beyond their adherence to the standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described. The tests are objective measurements and standardized inspections based on the ASTM D 3578-95 standard, rather than subjective assessments requiring adjudication.
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
This question is not applicable. The device is "Nitrile Examination Gloves," a physical medical device, not an AI software or interpretative tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is defined by the objective performance specifications and test methods outlined in ASTM D 3578-95. This includes:
- Physical measurements: Length, width, thickness.
- Material properties: Tensile strength, ultimate elongation (before and after aging).
- Defect criteria: Visible defects, watertight holes, residual powder, bio-compatibility (meeting FDA pinhole requirement).
8. The sample size for the training set
This question is not applicable. The device is a physical medical glove and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical medical 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.