(36 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, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.
The provided text describes the acceptance criteria and performance of Vinyl Patient Examination Gloves, Powdered, submitted by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. This submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial for novel device performance. Therefore, many of the typical elements of a study proving performance against acceptance criteria (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or not provided in the same manner as for a new, complex medical device.
However, based on the provided text, here's an analysis of the acceptance criteria and the "study" (non-clinical performance data) that demonstrates the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from ASTM D5250-92) | Reported Device Performance (Applicant Device) |
|---|---|---|
| Length (mm) | ||
| Size S | Min. 230 mm | 240 ± 5 mm |
| Size M | Min. 230 mm | 240 ± 5 mm |
| Size L | Min. 230 mm | 240 ± 5 mm |
| Size XL | Min. 230 mm | 240 ± 5 mm |
| Width (mm) | ||
| Size S | 85 ± 5 mm | 87 ± 3 mm |
| Size M | 95 ± 5 mm | 98 ± 3 mm |
| Size L | 105 ± 5 mm | 106 ± 3 mm |
| Size XL | 115 ± 5 mm | 114 ± 3 mm |
| Thickness (mm) | ||
| Finger | Min. 0.05 mm | Min. 0.08 mm |
| Palm | Min. 0.08 mm | Min. 0.11 mm |
| Physical Properties Before Aging | ||
| Tensile Strength (MPa) | Min. 9 MPa | Min. 10 MPa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| Physical Properties After Aging | ||
| Tensile Strength (MPa) | Min. 9 MPa | Min. 9.5 MPa |
| Ultimate Elongation (%) | Min. 300% | Min. 300% |
| FDA Water Leak Test | (Implicitly, to meet AQL 4.0) | Meets AQL 4.0 with an Inspection Level of S-4 |
| Biocompatibility (Modified Draize Test) | Absence of clinically significant irritation or allergic contact dermatitis | Did not induce clinically significant irritation nor show any evidence of induced allergic contact dermatitis in human subjects. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves) used for each physical and water leak test. The data provenance is implied to be from the manufacturer (Shanghai Foremost Plastic Industrial Co., Ltd.) and tested according to ASTM and FDA standards. It's an internal validation by the manufacturer. The data is most likely prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of this device. The "ground truth" for the physical and water leak tests is established by the specified ASTM D5250-92 standard and the FDA 1000 ml water leak test protocol. These are objective measurements against defined criteria, not subjective interpretations requiring expert consensus like in image analysis or clinical diagnosis.
For the Modified Draize Test, presumably, medical professionals or dermatologists would have evaluated the human subjects, but the number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against a standard, not 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
Not applicable. This device is a physical product (gloves) and does not involve AI or human readers/interpreters in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
- Physical Properties (Length, Width, Thickness, Tensile Strength, Elongation): The "ground truth" is established by the ASTM D5250-92 standard, which defines the acceptable ranges and minimums for these properties.
- Water Leak Test: The "ground truth" is defined by the FDA 1000 ml water leak test protocol, specifically aiming to meet an Acceptable Quality Level (AQL) of 4.0 with an Inspection Level of S-4.
- Biocompatibility (Modified Draize Test): The "ground truth" is the clinical observation of human subjects for the presence or absence of significant irritation or allergic contact dermatitis.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned or implied for this device.
§ 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.