(351 days)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This type of medical device submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characteristics, rather than clinical studies with human subjects or AI-driven performance metrics. Therefore, many of your requested points regarding acceptance criteria, study design, and AI performance are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the methods used to prove the device meets these criteria.
Acceptance Criteria and Device Performance Study for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
This summary is based on the provided 510(k) submission, K130751. The device in question is a Class I medical device (patient examination glove), and its clearance relied on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and other regulatory requirements. Clinical studies and AI performance metrics are not applicable to this type of device and submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device meets the requirements of ASTM standard D 5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reapproved 2011), 21 CFR 800.20, and ISO 10993-10: 2002/Amd. 1:2006(E).
| Feature | Acceptance Criteria (ASTM D5250-06 (Reapproved 2011) & other standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material | PVC | PVC |
| Donning Powder | PU / Surface Coating Agent | PU / Surface Coating Agent (Results generated values below 2mg residual powder) |
| Length | ≥230mm min. for all sizes (ASTM D5250) | 230mm min for all sizes |
| Width | Small 80-90mm, Medium 90-100mm, Large 100-110mm, X large 110-120mm | Small 80-85mm, Medium 95-97mm, Large 102-108mm, X large 114-118mm |
| Thickness | Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250) | Finger 0.05mm min., Palm 0.08mm min. |
| Elongation (Physical) | Before aging/after aging ≥300% (ASTM D5250) | Before aging/after aging ≥300% |
| Tensile Strength (Physical) | Before aging/after aging ≥14MPa (ASTM D5250) | Before aging/after aging ≥14MPa |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250, ASTM D5151 (Inspection Level I, AQL 2.5) | Meets ASTM D5151 (Holes: Inspection Level I, AQL 2.5) |
| Residual Powder | Meets ASTM D6124-06 (Reapproved 2011) | Meets ASTM D6124 (Results generated values below 2mg of residual powder) |
| Biocompatibility (Skin Irritation & Sensitization) | Meets ISO 10993-10:2002/Amd.1:2006 | Non-irritant or non-sensitizer (Meets ISO 10993-10:2002/Amd.1:2006) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in the context of clinical trials or AI validation. Instead, the performance data is generated from testing batches of gloves to ensure compliance with the AQL (Acceptance Quality Limit) for pinholes and other physical property tests as per the mentioned ASTM standards. These tests are internal to the manufacturing process and documented for regulatory submission. The data provenance is from the manufacturer's own testing in China, as the applicant is Cabin Plastic Co., Ltd. from China. The studies are not prospective or retrospective clinical studies but rather product testing and characterization.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. For this device, ground truth is established by objective measurements against quantitative performance standards (e.g., tensile strength, dimensions, pinhole AQL) as defined by ASTM and ISO standards, and regulatory requirements (e.g., 21 CFR 800.20). No human experts are used to "establish ground truth" in the clinical sense for this type of device.
4. Adjudication Method for the Test Set
Not applicable. Measurements against established technical standards do not typically involve adjudication panels in the way clinical studies or image-based AI studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study was done. This type of study is not relevant for a patient examination glove. The device's performance is assessed based on its physical and chemical properties, not diagnostic accuracy requiring human reader interpretation with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. There is no algorithm or AI component in this device. Performance is inherently "standalone" in the sense of the physical glove performing its intended function (barrier protection) based on its material properties and manufacturing quality.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is established by objective technical standards and regulatory requirements. This includes:
- ASTM Standard D5250-06 (Reaffirmation 2011): Specification for Vinyl Patient Examination Gloves.
- ASTM Standard D5151-06 (Reapproved 2011): Standard Test Method for Detection of Pinholes in Medical Gloves.
- ASTM Standard D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: Regulations regarding medical device requirements.
- ISO 10993-10:2002/Amd.1:2006(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to consistently produce gloves meeting the established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The manufacturing process is designed to meet the aforementioned ASTM, ISO, and CFR standards, which serve as the "ground truth" for quality and performance.
§ 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.