(167 days)
Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The provided text describes the acceptance criteria and the study results for the "Disposable Medical Rubber Examination Gloves" (K221374) device.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Category | Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Acute Systemic Toxicity Test | ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. | The test article has no potential acute systemic toxicity on ICR mice in the extraction method. |
| Skin Irritation Test | ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation. | Under the experimental conditions, the test article has no skin irritation on rabbits. | |
| Skin Sensitization Test | ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization. | Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the method. | |
| Physical Properties | Physical Dimensions Test | The gloves shall comply with the dimension requirements prescribed in ASTM D3578-19 Table 2. (Inspection Level: S-2, AQL: 4.0) | |
| (Specific dimensions for Length, Width, and Thickness are detailed in the "Characteristics" table earlier, but the acceptance criteria generally refer to this ASTM standard and AQL levels) | The subject device comply with the dimension requirements prescribed in ASTM D3578-19. (e.g., Length (mm): 230 min; Width (mm) for XS: 75 ± 5, S: 85 ± 5, M: 95 ± 5, L: 105 ± 5, XL: 115 ± 5; Thickness (mm) For all sizes: 0.08 min.) | ||
| Physical Property Characteristics Test (Tensile Strength & Ultimate Elongation) | Before and after accelerated aging, the gloves shall conform to the physical requirements specified in ASTM D3578-19 Table 3. (Inspection Level: AQL: 4.0) | ||
| Before Aging: Tensile Strength 18 MPa, min; Ultimate Elongation 650 % min | |||
| After Accelerated Aging: Tensile Strength 14 MPa, min; Ultimate Elongation 500 % min | Before and after accelerated aging, the subject device conform to the physical requirements specified in ASTM D3578-19 Table 3. | ||
| Before Aging: Tensile Strength 18MPa, min; Ultimate Elongation 650 % min | |||
| After Accelerated Aging: Tensile Strength 14 MPa, min; Ultimate Elongation 500 % min (Actual values provided in comparison table: e.g., Tensile Strength Before Aging >18.04 MPa, After Aging >15.02 MPa across sizes; Ultimate Elongation Before Aging >650%, After Aging >501% across sizes) | |||
| Freedom From Holes Test | Inspection Level: I, AQL: 2.5 | No water leakage is inspected. The subject device conform to the requirements specified in ASTM D5151. (AQL 2.5) | |
| Powdered Glove Test (Residual Powder) | Inspection Level: N=5, Residual Powder less than 2 mg per glove. | Residual Powder less than 2 mg per glove. The subject device conform to the requirements specified in ASTM D6124. (Reported values: XS 0.28, S 0.25, M 0.31, L 0.25, XL 0.35 mg/glove) | |
| Extractable Protein Test | Inspection Level: N=3, Less than 200 µg/dm². | The results showed that the average Extractable Protein of test samples met the acceptance criteria in ASTM D5712. (Reported values: Small 124.36, Medium 140.78, Large 134.26, Extra Large 159.46 µg/dm²) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Physical Dimension, Physical Property, Freedom From Holes, Powdered Glove, and Extractable Protein Tests: The sample sizes are specified by the ASTM standards and AQL levels. For example:
- Physical Dimensions: Inspection Level S-2, AQL 4.0 (This implies a sampling plan defined by ASTM D3578-19, which would dictate the sample size based on lot size).
- Physical Property Characteristics: AQL 4.0 (similar to above).
- Freedom From Holes: Inspection Level I, AQL 2.5 (implies a sampling plan as per ASTM D5151-06).
- Powdered Glove Test: N=5 (5 gloves were tested for residual powder).
- Extractable Protein Test: N=3 (3 samples were tested for extractable protein).
- Sample Size for Biocompatibility Tests:
- Acute Systemic Toxicity: ICR mice (number not specified, but typically a standard number per group as per ISO 10993-11).
- Skin Irritation: Rabbits (number not specified, but typically a standard number as per ISO 10993-23).
- Skin Sensitization: Guinea pigs (number not specified, but typically a standard number as per ISO 10993-10, using the Guinea Pig Maximization method).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they are "bench tests" and "nonclinical tests" conducted for the subject device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd. in China.
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)
This information is not applicable as the document describes performance testing of a physical medical device (examination gloves) against established engineering and biocompatibility standards, not an AI/imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. The device under review is an examination glove, and its performance is determined by objective physical and chemical tests, not by human interpretation or 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 information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the Disposable Medical Rubber Examination Gloves is established by:
- International Standards: Primarily ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties and dimensions, and various ISO 10993 series standards for biocompatibility (ISO 10993-11 for systemic toxicity, ISO 10993-23 for irritation, ISO 10993-10 for sensitization).
- Objective Test Methods: Laboratory tests as described (e.g., steel ruler and thickness measurement apparatus for dimensions, dumbbell/straight section specimens for physical properties, water leakage for holes, gravimetric methods for residual powder, modified Lowry Method for protein content).
- Animal Models: For biocompatibility tests (ICR mice for acute systemic toxicity, rabbits for skin irritation, guinea pigs for skin sensitization).
8. The sample size for the training set
This information is not applicable. The device is a physical product (examination gloves), not a software algorithm that requires a training set. The performance is based on manufacturing and testing against established standards.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.