(107 days)
The Disposable Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject devices have two color: blue and clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. This document is for a Class I medical device, which falls under general controls and typically does not require extensive clinical studies or complex performance criteria like those for AI-powered diagnostic tools. Therefore, the information needed to answer the prompt's specific questions regarding acceptance criteria, study methodologies for AI/software, ground truth establishment, expert adjudication, or MRMC studies for this type of device is not present in the document.
The document mainly focuses on demonstrating substantial equivalence to a predicate device (K163168) through:
- Identical Intended Use: Both devices are disposable gloves for preventing contamination between patient and examiner.
- Similar Technological Characteristics: Material (vinyl), design (ambidextrous, powder-free), and basic physical properties.
- Compliance with Recognized Standards: ASTM D5250 (physical dimensions, performance), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ISO 10993 (biocompatibility).
Based on the provided document, here's an attempt to address your questions, highlighting what information is available and what is not applicable or not provided for this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a pass/fail table format, nor does it typically report specific "performance" metrics in the way an AI algorithm would (e.g., sensitivity, specificity). Instead, it shows comparative data with the predicate device against established standards.
Here's an extraction of relevant "performance" data and standards from the "Technological Characteristic Comparison Table" (Table3) and "Device Dimensions Comparison" (Table2), indicating compliance with ASTM standards which serve as de facto acceptance criteria for these physical properties:
| Item | Acceptance Criteria (Standard / Requirements) | Reported Device Performance (Subject Device K210522) |
|---|---|---|
| Material | Vinyl | Vinyl |
| Length (mm) | min 230 (meets ASTM D5250) | 230 (S, M, L, XL) |
| Width (mm) | Varies by size, e.g., 85 (S), 95 (M), 105 (L), 115 (XL) (±5 tolerance, meets ASTM D5250) | 85 (S), 95 (M), 105 (L), 115 (XL) |
| Thickness (Finger, mm) | 0.08 min (meets ASTM D5250) | 0.08 min |
| Thickness (Palm, mm) | 0.08 min (meets ASTM D5250) | 0.08 min |
| Physical Properties: Before Aging - Tensile Strength | 14 MPa, min (meets ASTM D5250) | 14 MPa, min |
| Physical Properties: Before Aging - Ultimate Elongation | 500% min (meets ASTM D5250) | 500% min |
| Physical Properties: After Aging - Tensile Strength | 14 MPa, min (meets ASTM D5250) | 14 MPa, min |
| Physical Properties: After Aging - Ultimate Elongation | 400% min (meets ASTM D5250) | 400% min |
| Freedom from Holes | Comply with ASTM D5250; Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Complies with ASTM D5250; Free from holes when tested per ASTM D5151 AQL=2.5 |
| Powder Content | Meet the requirements of ASTM D6124 | Meets the requirements of ASTM D6124 |
| Biocompatibility - Irritation | Not an irritant (ISO 10993-10) | Under the conditions of the study, not an irritant |
| Biocompatibility - Sensitization | Not a sensitizer (ISO 10993-10) | Under conditions of the study, not a sensitizer. |
| Biocompatibility - Cytotoxicity | Did not show potential toxicity to L-929 cells (ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells. |
| Label and Labeling | Meet FDA's Requirement | Meets FDA's Requirement |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical tests" such as those for physical properties, freedom from holes, powder content, and biocompatibility, which are conducted on samples of the manufactured gloves.
- Sample Size: The exact sample sizes for each specific test (e.g., number of gloves tested for tensile strength, number of gloves tested for holes, number of specimens for biocompatibility) are not explicitly stated in this summary document. These details would typically be found in the full test reports referenced by the standards (e.g., ASTM D5151 specifies sampling plans for AQL).
- Data Provenance: The tests were performed by the manufacturer (Shandong Shengshixincheng Medical Science & Technology Co., Ltd. is the submitter) and/or their designated testing labs. The country of origin for the data is implicitly China, where the manufacturer is located. The tests are prospective in the sense that they are performed on samples of the manufactured device to verify its properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device. "Ground truth" established by experts (like radiologists for imaging) is relevant for diagnostic devices that interpret complex data or images. For examination gloves, the "ground truth" is defined by the physical and chemical properties measured against established engineering and biocompatibility standards (e.g., a glove either passes or fails a hole test, or its tensile strength meets the specified MPa). No human experts are needed to adjudicate these objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are specific to scenarios where human interpretation or consensus is required (e.g., in medical image reading trials). The tests for examination gloves involve objective measurements, not subjective human 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. MRMC studies are used for evaluating the performance of diagnostic imaging devices, particularly those involving AI assistance, and comparing human reader performance with and without AI. This device is an examination glove, not a diagnostic imaging device or an AI product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical product (a glove), not an algorithm or software requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective engineering standards, physical measurements, and chemical/biological test results. For example:
- Physical dimensions: Measured against specified ranges (e.g., length, width, thickness).
- Tensile Strength & Elongation: Measured in MPa and % elongation against minimum thresholds.
- Freedom from Holes: Determined by an objective test method (ASTM D5151) with an Acceptable Quality Limit (AQL).
- Powder Content: Measured against a maximum threshold (ASTM D6124).
- Biocompatibility: Determined by standardized in-vitro and in-vivo tests (ISO 10993-5, -10) for irritation, sensitization, and cytotoxicity.
These are not based on expert consensus, pathology, or outcomes data in the medical sense, but rather on compliance with established consensus standards for medical devices.
8. The sample size for the training set
This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This question is 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.