(88 days)
Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Medical Examination Gloves is a patient examination glove and it is made from nitrile compound. It is a single-use, powder-free and non-sterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
The provided text describes the acceptance criteria and the study conducted for "Nitrile Medical Examination Gloves." This device is a Class I medical device, and the evaluation focuses on its substantial equivalence to a predicate device (K192333).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (from ASTM D6319-19 unless otherwise specified) | Reported Device Performance |
|---|---|---|
| Freedom from Holes | Any glove showing droplet, stream, or other water leakage considered failed. AQL 2.5 | Did not show droplet, stream, or other type of water leakage (0 failures out of 200 samples tested). |
| Physical Dimension Test | Length: S: Min 220mm, M: Min 230mm, L: Min 230mm, XL: Min 230mm | |
| Width: S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm | ||
| Thickness: Finger Min 0.05mm, Palm Min 0.05mm | Length: S: 241-246mm, M: 243-252mm, L: 287-298mm, XL: 288-292mm | |
| Width: S: 85-88mm, M: 92-94mm, L: 109-110mm, XL: 114-117mm | ||
| Thickness: Finger 0.08-0.125mm, Palm 0.063-0.082mm | ||
| (0 failures out of 13 samples tested/size). | ||
| Physical Requirement Test (Tensile Strength) | Before Aging: 14 Mpa, min. | |
| After Aging: 14 Mpa, min. | Before Aging: 19.6-26.7 Mpa | |
| After Aging: 20.9-26.1 Mpa | ||
| (0 failures out of 13 samples tested/L size). | ||
| Physical Requirement Test (Elongation) | Before Aging: 500% min. | |
| After Aging: 400% min. | Before Aging: 650-700% | |
| After Aging: 560-620% | ||
| (0 failures out of 13 samples tested/L size). | ||
| Powder Free Gloves | Max. 2.0mg/glove | Average: 1.9 mg (5 samples tested). |
| In Vitro Cytotoxicity | Under conditions of the study, the test article must not show potential toxicity (ISO 10993-5:2009) | Fail – Under the condition of the test, the test article was found to be cytotoxic. (Note 2 states that additional testing for systemic toxicity was performed due to this result, and it passed). |
| Skin Sensitization | Under the conditions of the study, the test article must be found to be non-sensitizing (ISO 10993-10:2010) | Pass – Under the condition of the test, the test article was found to be non-sensitizing. |
| Skin Irritation Test | Under the conditions of the test, the test article must be found to be non-irritating (ISO 10993-10:2010) | Pass – Under the conditions of the test, the test article was found to be non-irritating. |
| Acute Systemic Toxicity | Under the conditions of the test, the test article must be found to be non-systemic toxicity (ISO 10993-11:2017) (Performed in response to cytotoxicity failure, as per Note 2 and comparison to predicate) | Pass – Under the condition of the test, the test article was found to be non-systemic toxicity. (This was done to address the initial cytotoxicity finding, and the device met the requirements, similar to the predicate device which also had initial cytotoxicity but acceptable systemic toxicity.) |
2. Sample Size Used for the Test Set and Data Provenance
- Freedom from Holes: 200 samples
- Physical Dimension Test: 13 samples per size (S, M, L, XL - so a total of 52 samples for dimensions)
- Physical Requirement Test (Tensile Strength & Elongation): 13 samples for L size (implies this size was representative or the primary one tested for these characteristics).
- Powder Free Gloves: 5 samples.
- Biocompatibility Tests (Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity): The exact number of samples for each biocompatibility test is not explicitly stated in this document (e.g., number of animals or cell cultures). However, these tests are generally conducted according to the specified ISO standards, which define their own sample size requirements.
Data Provenance: The document does not explicitly state the country of origin for the data generation. However, the submitter is based in China, suggesting the testing was likely conducted or overseen by facilities associated with the manufacturer, potentially in China or by internationally recognized labs. The studies are non-clinical bench testing, not clinical studies with human patients. Thus, the distinction between retrospective and prospective is less relevant here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This device did not involve human experts establishing ground truth for a diagnostic AI. The evaluation is based on bench testing against established ASTM and ISO standards. The "ground truth" is defined by the objective pass/fail criteria within those standards.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench testing study, not a medical image or diagnostic test requiring expert adjudication. The results are objective measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This device is a medical examination glove, not a diagnostic AI system or a device intended to assist human readers in interpretation. Therefore, an MRMC comparative effectiveness study is not applicable.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
No. This is a physical medical device (glove), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the performance evaluation is based on established industry standards and objective measurements:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151: Test Method for Detection of Holes in Medical Gloves.
- ASTM D412: Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension.
- ASTM D3767: Practice for Rubber—Measurement of Dimensions.
- ASTM D573: Test Method for Rubber—Deterioration in an Air Oven.
- ASTM D6124: Test Method for Residual Powder on Medical Gloves.
- ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2017: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set 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.