(50 days)
The 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.
Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.
The provided document is a 510(k) summary for the WRP COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE. It details the product's specifications and its compliance with relevant standards. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D 3578-99) | COMFIT Powder Free Blue Nitrile Examination Glove, Sterile - Reported Performance |
|---|---|---|
| Watertight (1000 ml) | G-I, AQL 2.5 | Pass (Single Sampling Plan, G-I, AQL 2.5; Multiple Sampling Plan, G-II, AQL 4.0) |
| Length (mm) | ||
| - XS | min 220 | - (Not reported for XS) |
| - S | min 220 | 248 |
| - M | min 230 | 245 |
| - L | min 230 | 245 |
| - XL | - | - (Not reported for XL) |
| Palm Width (mm) | ||
| - XS | 70 ± 10 | - (Not reported for XS) |
| - S | 80 ± 10 | 84 |
| - M | 95 ± 10 | 94 |
| - L | 111 ± 10 | 106 |
| - XL | - | - (Not reported for XL) |
| Single Wall Thickness (mm) | ||
| - Finger | min 0.08 | 0.19 |
| - Palm | min 0.08 | 0.13 |
| Physical Properties: Before Aging | ||
| - Tensile Strength (MPa) | min 14.0 | 25.01 |
| - Ultimate Elongation (%) | min 700 | 674 (Note: This is an exception to the ASTM standard, as stated in the text.) |
| Physical Properties: After Aging | ||
| - Tensile Strength (MPa) | min 14.0 | 25.32 |
| - Ultimate Elongation (%) | min 500 | 649 |
| Residual Powder | Less than 2mg/glove (Implicit from the standard for powder-free gloves) | Less than (Value is cut-off due to poor OCR, but implied to be compliant) |
Note: The document explicitly states that the device "meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test." However, the conclusion later states that the nitrile gloves "meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength." It also mentions that "Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement fro tensile strength."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for length, thickness, or watertightness). It refers generally to "Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test." and "refer to Attachment 8 of Device Test Report of Compliance" for detailed results.
- Data Provenance: The tests were conducted internally by WRP Asia Pacific Sdn Bhd (Malaysia). The tests were performed to comply with ASTIM D 3578-99 and FDA 1000 ml watertight test. The data is retrospective in the sense that it was collected and analyzed as part of the 510(k) submission process, but the tests themselves would have been prospective evaluations of manufactured gloves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable. The "ground truth" for glove performance characteristics is established by objective measurements against predefined international standards (ASTM D 3578-99) and regulatory tests (FDA 1000 ml watertight test), not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where there might be disagreement among reviewers (e.g., in image interpretation studies). For objective physical and performance tests of medical gloves, measurements are taken, and the results are compared directly to the specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI Assistance
- This information is not applicable. The device described is a medical glove, not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth is based on established international standards and regulatory performance requirements. Specifically:
- ASTM D 3578-99 Standard Specification for Rubber Examination Gloves: This standard defines the acceptable physical dimensions, and mechanical properties (tensile strength, ultimate elongation) before and after aging for examination gloves.
- FDA 1000 ml Watertight Test: This is a specific regulatory test to assess the barrier integrity of examination gloves.
8. The Sample Size for the Training Set
- This information is not applicable. The device is a manufactured product (medical glove) undergoing performance testing, not a machine learning model that requires a training set. The manufacturing process itself (Good Manufacturing Practices) ensures consistent quality.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the reasons mentioned in 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.