(52 days)
A patient examination glove is a disposable device intended for medical purpose which is worn on examiner's hand or finger to prevent contamination between patient and examiner.
(1) Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
(2) Vinyl Patient Examination Glove, Powder Free, 80LYZ
(3) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
Here's a summary of the acceptance criteria and the study details for the "Vinyl Patient Examination Gloves, Powder Free" manufactured by Universal Gloves Corporation, based on the provided 510(k) submission (K980093).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category/Test | Specified Acceptance Criteria (from ASTM D5250-92 & FDA) | Reported Device Performance (as stated by manufacturer) |
|---|---|---|
| Dimensions | ||
| Length (mm) | Min. 230mm (for all sizes S, M, L, XL) | $240 \pm 5$mm (for all sizes S, M, L, XL) |
| Width (mm) | ||
| Size S | $85 \pm 5$mm | $87 \pm 3$mm |
| Size M | $95 \pm 5$mm | $97 \pm 3$mm |
| Size L | $105 \pm 5$mm | $107 \pm 3$mm |
| Size XL | $115 \pm 5$mm | $114 \pm 3$mm |
| Thickness (mm) | ||
| Finger | Min. 0.05mm | Min. 0.08mm |
| Palm | Min. 0.08mm | Min. 0.11mm |
| Physical Properties | ||
| Before Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 10Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| After Aging | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| Pin-holes (Water Leak Test) | Meets AQL 4.0 with an Inspection Level of S-4 (FDA 1000ml Water Leak Test) | Meets AQL 4.0 with an Inspection Level of S-4 (FDA 1000ml Water Leak Test) |
| Biocompatibility | No clinically significant irritation or allergic contact dermatitis (Modified Draize Test) | Did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects |
Study that Proves the Device Meets Acceptance Criteria:
The provided document describes a non-clinical performance study and a clinical performance study.
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Performance Data (Physical Properties & Water Leak Test): The document does not explicitly state the sample size used for the mechanical property tests (Length, Width, Thickness, Tensile Strength, Ultimate Elongation) nor for the FDA Water Leak Test. It simply states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." and lists the observed performance. ASTM D5250-92 specifies sampling plans, but the specific sample sizes used by the manufacturer are not detailed in this summary.
- Clinical Performance Data (Biocompatibility - Modified Draize Test): The document states "human subjects" were used, but the specific number is not provided.
- Data Provenance: The manufacturing company, Universal Gloves Corporation, is located in Tainan, Taiwan, R.O.C. (Republic of China). All data would originate from studies conducted by or for this manufacturer. The studies are assumed to be prospective as they are assessing the performance of a new device for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- For physical and performance tests (Length, Width, Thickness, Tensile Strength, Elongation, Water Leak Test): No external "experts" in the sense of medical professionals are typically involved in establishing ground truth for these objective physical measurements. The ground truth is established by the specified ASTM standards and FDA test methods themselves, which outline the procedures for measurement and evaluation. The "experts" implementing these would be laboratory technicians or engineers qualified in materials testing and quality control. Their number and specific qualifications are not detailed in the summary.
- For the Clinical Performance (Modified Draize Test): Medical professionals (e.g., dermatologists or clinicians) would be involved in evaluating the skin reactions of human subjects. The number and specific qualifications of these experts are not provided in the summary.
4. Adjudication Method for the Test Set:
- For physical and performance tests: Adjudication is not typically applicable for objective performance tests against a defined standard. Measurements are taken, and results are compared directly to the specified criteria.
- For the Clinical Performance (Modified Draize Test): The method of evaluation would typically involve clinical assessment by qualified personnel. The document does not specify any particular adjudication method (e.g., 2+1, 3+1 consensus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The device in question is a medical glove, which does not involve "readers" or "cases" in that context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This question is not applicable to this device. A medical glove is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. Type of Ground Truth Used:
- For physical and performance tests: The ground truth is based on established industry standards and regulatory test methods. Specifically, ASTM Standard D5250-92 details the required physical properties and dimensions for vinyl patient examination gloves, and the FDA 1000ml Water Leak Test specifies the method for pin-hole detection.
- For biocompatibility: The ground truth for biocompatibility (irritation and sensitization) is established through clinical observation and assessment by qualified medical professionals using the Modified Draize Test on human subjects.
8. Sample Size for the Training Set:
- This question is not applicable as an AI/ML algorithm is not involved in this device or its development. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- This question is not applicable as there is no training set.
§ 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.