(120 days)
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
The provided document describes the acceptance criteria and performance data for "Powderfree Nitrile Examination Gloves Coated with Allogel®".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319 Standard) | Reported Device Performance (Powder Free Nitrile Exam Gloves Coated with Allogel®) |
|---|---|---|
| Watertight (1000ml) (ASTM D 5151) | Multiple Normal in accordance with ISO 2859 GI AQL=2.5 | Pass GI AQL = 2.5 |
| Length (mm) | 240 mm minimum for all sizes | |
| - Size XS | Min 220 | |
| - Size S | Min 220 | |
| - Size M | Min 230 | |
| - Size L | Min 230 | |
| - Size XL | ||
| Palm Width (mm) | ||
| - Size XS | 70 ± 10 | 75 - 80 |
| - Size S | 80 ± 10 | 83 - 84 |
| - Size M | 95 ± 10 | 94 - 96 |
| - Size L | 110 ± 10 | 107 - 109 |
| - Size XL | 120 ± 10 | 113 - 114 |
| Thickness (mm) (Single Layer) | ||
| - Finger | Min 0.05 | Min 0.12 |
| - Palm | Min 0.05 | Min 0.10 |
| - Cuff | Min 0.05 | Min 0.08 |
| Physical Properties (ASTM D 412) | ||
| - Before Aging: Tensile Strength (MPa) | Min 14 | 18 - 31 |
| - Before Aging: Ultimate Elongation (%) | Min 500 | 530 - 600 |
| - After Aging: Tensile Strength (MPa) | Min 14 | 18 - 29 |
| - After Aging: Ultimate Elongation (%) | Min 400 | 500 - 550 |
| Powder Content (ASTM D6124) | Max 2.0 mg/glove | Below 2 mg/glove |
| Biocompatibility Tests | Not Sensitizers or Irritants | Passed criteria of not being Sensitizers or Irritants |
| - Primary Skin Irritation Test | Passed | |
| - Guinea Pig Sensitization (Buehler) test | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- The document states "Data of an actual representative shipment is detailed in Section 14" for various physical property tests, but Section 14 is not provided in the input. Therefore, the specific sample size for the test set is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the data is from an "actual representative shipment," suggesting prospective data collection from manufacturing batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable to this type of device (examination gloves). The performance is assessed against established ASTM standards and FDA watertightness requirements, not expert consensus on an interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable. No adjudication method involving human interpretation is described as the tests are objective measurements against pre-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
- An MRMC comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI systems, not for physical examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through laboratory testing, not algorithmic output.
7. The Type of Ground Truth Used
- The ground truth used for performance evaluation are established industry standards and regulatory requirements:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- FDA Water Leak Test (likely based on ASTM D5151)
- ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Biocompatibility test criteria (not specified in detail but states "not being Sensitizers or Irritants").
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" for physical product testing against objective standards. The gloves are manufactured and then samples are tested for conformance.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above. There is no training set mentioned or implied for this type of 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.