(24 days)
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
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 natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.
The provided text describes the acceptance criteria and performance data for the "DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (DERMAGRIP Powder Free Latex Examination Glove) |
|---|---|---|
| Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on: 1) Single Sampling Plan, S-4, AQL 4.0; 2) Multiple Sampling Plan, GII, AQL 4.0 |
| Length (mm) | ||
| Size XS | min 220 | 245 |
| Size S | min 220 | 255 |
| Size M | min 230 | 297 |
| Size L | min 230 | 249 |
| Size XL | - | 253 |
| Palm Width (mm) | ||
| Size XS | 70 ± 10 | 77 |
| Size S | 80 ± 10 | 81 |
| Size M | 95 ± 10 | 96 |
| Size L | 111 ± 10 | 105 |
| Size XL | - | 114 |
| Single Wall Thickness (mm) | ||
| Finger | min 0.08 | 0.36 |
| Palm | min 0.08 | 0.25 |
| Physical Properties - Before Aging | ||
| Tensile Strength (MPa) | min 14 | 28.63 |
| Ultimate Elongation (%) | min 700 | 962 |
| Physical Properties - After Aging | ||
| Tensile Strength (MPa) | min 14 | 18.43 |
| Ultimate Elongation (%) | min 500 | 1007 |
| Powder Content | - | below 2 mg/glove |
| Protein Content | - | below 50 microgram/gram |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a specific sample size (e.g., number of gloves tested). However, for the "Watertight" test, it refers to "Single Sampling Plan, S-4, AQL 4.0" and "Multiple Sampling Plan, GII, AQL 4.0". These are sampling plans from quality control standards, which implicitly define sample sizes based on lot size and AQL. The specific sample sizes are not directly provided in the text.
- Data Provenance: The tests were conducted by WRP Specialty Products Sdn. Bhd. in Malaysia, as indicated by the company's address. The data is retrospective, as it's a summary of performance data collected prior to the 510(k) submission date of January 12, 1999.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is a patient examination glove and the acceptance criteria are based on objective physical and chemical properties as defined by ASTM standards and FDA watertight test requirements, not expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
- This information is not applicable as the acceptance criteria are based on objective, quantitative measurements against established standards, not on 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 information is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable as the device is a medical glove, not an algorithm. The performance evaluation is of the physical product itself.
7. The type of ground truth used:
- The "ground truth" for this device is based on objective, quantitative measurements defined by:
- ASTM D3578-95 standard for natural rubber latex patient examination gloves.
- FDA 1000 ml watertight test.
- Specific thresholds for powder content and protein content.
8. The sample size for the training set:
- This information is not applicable as the device is a physical product (glove) and not a software or AI model that requires a training set in the conventional sense. The manufacturing process is subject to quality control, which involves sampling, but this is distinct from an AI training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons stated 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.