(70 days)
Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Latex Examination Gloves Powder Free With Lined.
The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.
The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.
Here's an analysis of the available information regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Minimum) | Reported Device Performance (Reference) |
|---|---|---|
| Dimensions | (ASTM D 3578-01ae2 Standard) | |
| Length mm (min.) | 220 (Small), 230 (Medium, Large, X-Large) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Palm Width mm | 80±10 (Small), 95±10 (Medium), 111±10 (Large), 120±10 (X-Large) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Thickness (min.) | ||
| - Cuff mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - Palm mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - Finger Tip mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Physical Properties | ||
| Tensile Strength | ||
| - Before ageing | 18 Mpa (min) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - After ageing (70°C, 168 hrs) | 14 Mpa (min) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Ultimate Elongation | ||
| - Before ageing | 650 % (min.) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - After ageing (70°C, 168 hrs) | 500 % (min.) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Safety/Quality | ||
| Pin Hole Requirement | FDA requirement | Met (Certify: "Meets FDA pin hole requirement") |
| Labeling Claim | Accuracy of labeling information | Met (Certify: "Meets labeling claim") |
| Total Water Extractable Protein | ≤ 50 micrograms per gram | Met (Stated in device name and indication for use) |
Notes:
- The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
- The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."
4. Adjudication Method for the Test Set
This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective 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. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
- Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
- Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").
8. The Sample Size for the Training Set
This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.
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. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.
§ 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.