(35 days)
A 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.
Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.
This is a 510(k) summary for Vinyl Patient Examination Gloves, Powdered. It describes the device, its intended use, and compares its performance to the ASTM D5250-92 standard and the FDA 1000ml water leak test.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D5250-92) | Reported Device Performance |
|---|---|---|
| Length (mm) | ||
| Size S | Min. 230mm | 240±5mm |
| Size M | Min. 230mm | 240±5mm |
| Size L | Min. 230mm | 240±5mm |
| Size XL | Min. 230mm | 240±5mm |
| Width (mm) | ||
| Size S | 85±5mm | 87±3mm |
| Size M | 95±5mm | 97±3mm |
| Size L | 105±5mm | 107±3mm |
| Size XL | 115±5mm | 114±3mm |
| 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% |
| Physical Properties (After Aging) | ||
| Tensile Strength (Mpa) | Min. 9Mpa | Min. 9.5Mpa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | Meets | Meets AQL 4.0 with an Inspection Level of S-4 |
Study Proving Device Meets Acceptance Criteria:
The document states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." It also mentions a "Modified Draize Test" for clinical performance.
2. Sample size used for the test set and the data provenance
- Non-Clinical Performance Data (Physical Properties and Water Leak Test): The document does not specify the exact sample sizes used for each of the physical property tests (length, width, thickness, tensile strength, elongation). For the FDA Water Leak Test, it mentions an "Inspection Level of S-4," which is a sampling plan specification, but not the absolute number of gloves tested.
- Clinical Performance Data (Modified Draize Test): The document refers to "human subjects" but does not specify the number of subjects used in the Modified Draize Test.
- Data Provenance: The document is from Everrise Glove Products Co., Ltd. in Tainan Hsien, Taiwan, R.O.C. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are objective measurements against defined standards (ASTM D5250-92 and FDA 1000ml water leak test) and a standardized skin irritation test (Modified Draize Test). These do not typically involve human expert "ground truth" establishment in the way medical imaging or diagnostic algorithms do.
4. Adjudication method for the test set
This is not applicable as the tests performed are objective measurements against established standards, not subjective interpretations 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 is not applicable as the device is a vinyl patient examination glove, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product (gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance data is defined by the ASTM Standard D5250-92 specifications and the FDA 1000ml water leak test criteria. For the clinical performance, the "ground truth" is the lack of clinically significant irritation or allergic contact dermatitis as determined by the Modified Draize Test. This is based on direct observation of human physiological reactions rather than expert consensus on subjective data or pathology.
8. The sample size for the training set
This is not applicable. The context is a medical device (gloves) undergoing testing against established standards, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This 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.