(139 days)
Powder Free Polyethylene Examination Gloves,Blue Color 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.
The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large. The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.
The provided text describes the 510(k) premarket notification for U-MED Powder Free Polyethylene Examination Gloves, Blue Color. This is a medical device clearance submission, NOT a study proving the device meets acceptance criteria for an AI/ML algorithm. The document focuses on demonstrating substantial equivalence to a predicate device for examination gloves based on physical characteristics and performance standards.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable to this document.
However, I can extract the relevant "acceptance criteria" for this type of medical device (physical examination gloves) as described in the summary and how the device's performance was proven to meet these standards.
Here's a breakdown of the information that is applicable and the explanation of why other parts are not:
Acceptance Criteria and Device Performance for U-MED Powder Free Polyethylene Examination Gloves, Blue Color
This document describes the 510(k) premarket notification for a Class I medical device (patient examination glove). The "acceptance criteria" here refer to meeting established physical and performance standards for such gloves, not performance metrics for an AI/ML algorithm. The study described is a series of non-clinical tests to demonstrate conformity to these standards and substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D5250-06 (Reapproved 2015) | |
| Length | $\ge$ 230mm | Passed (Implied by meeting standard) |
| Width (Small) | 80-90 mm | Passed (Implied by meeting standard) |
| Width (Medium) | 90-100mm | Passed (Implied by meeting standard) |
| Width (Large) | 100-110mm | Passed (Implied by meeting standard) |
| Width (X Large) | 110-120 mm | Passed (Implied by meeting standard) |
| Thickness Fingertip | $\ge$ 0.05mm | Passed (Implied by meeting standard) |
| Thickness Palm | $\ge$ 0.08mm | Passed (Implied by meeting standard) |
| Physical Properties | ASTM D5250-06 (Reapproved 2015) | |
| Tensile strength (Before & After aging) | $\ge$ 11MPa | Demonstrated more than 11MPa |
| Elongated rate (Before & After aging) | $\ge$ 300% | Demonstrated more than 300% |
| Freedom from pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06 (Reapproved 2015); ASTM D5151-06 (Reapproved 2015) | Passed (Implied by meeting standard) |
| Powder Residual | ASTM D5250-06 (Reapproved 2015) and D6124-06 (Reaffirmation 2011) | Demonstrated less than 2 mg/glove |
| Biocompatibility | ISO 10993-10: 2010-08-01 | |
| Primary Skin Irritation | Passes | Not a primary skin irritant (Under the conditions of the study) |
| Dermal sensitization | Passes | Not a skin sensitizer (Under the conditions of the study) |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for tensile strength or pinholes). It generally states that "those verification tests of gloves were performed."
- Data Provenance: The tests were conducted by "qualified test centers." No specific country of origin for the testing data is explicitly mentioned beyond the applicant's address in China. The studies are non-clinical, essentially laboratory-based tests of physical properties, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and "ground truth" is established by adhering to established ASTM and ISO standards for physical and chemical properties testing, not through expert consensus on medical images or diagnoses. The "experts" would be the personnel at the qualified testing centers who perform these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an AI/ML algorithm or a comparative study involving human readers, there is no need for an adjudication method. Test results are based on objective measurements against 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:
- Not Applicable. This submission is for a physical medical device (examination gloves), not an AI-assisted diagnostic tool. No human reader studies (MRMC) were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm. Performance is assessed through physical and chemical testing of the gloves themselves.
7. The type of ground truth used:
- Standardized Test Results / Objective Measurements: The "ground truth" for this device is based on objective measurements and adherence to internationally recognized consensus standards for medical gloves, such as ASTM D5250, ASTM D5151, ASTM D6124, 21 CFR 800.20 (for pinholes), and ISO 10993-10 (for biocompatibility). These standards define acceptable ranges or thresholds for various physical properties (e.g., dimensions, tensile strength, elongation, pinhole rates, powder residual) and biological responses (skin irritation, sensitization).
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of submission.
§ 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.