(49 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text is for a 510(k) summary for Disposable Powder Free Vinyl Exam Gloves. This type of device does not typically undergo studies with the kind of acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone performance assessments that are relevant to AI/ML medical devices or complex diagnostic tools.
The "studies" described in this document are primarily non-clinical tests to ensure the physical properties and safety of the gloves meet established standards for medical devices.
Therefore, many of the requested categories (2-6, 8-9) are not applicable to this submission as they pertain to clinical or diagnostic performance, which is not evaluated for examination gloves in this manner.
Here's an interpretation based on the available information:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|---|
| Physical and Dimensions Testing | ASTM D5250-06 | Meets requirements (Section 7) |
| Watertight Test (Pinhole integrity) | FDA 1000 ml based on ASTM D-5151-06 (AQL 2.5, Inspection level I) | Meets requirements (Section 7) |
| Primary Skin Irritation | Acceptable biocompatibility | No primary skin irritant reactions (Section 7) |
| Skin Sensitization (Allergic Contact Dermatitis) | Acceptable biocompatibility | No sensitization reactions (Section 7) |
| Residual Powder | ASTM D6124-06 (no more than 2 mg powder per glove) | Meets "powder-free" claims (Section 7) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of samples is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) for the given batch size. Provenance is not specified, but the testing was done for the manufacturer (Xuzhou Full Sun Medical Products Ltd.) in China. This is retrospective testing of manufactured batches.
- Watertight Test: AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated. Provenance is not specified, but the testing was done for the manufacturer. This is retrospective testing.
- Primary Skin Irritation and Skin Sensitization: Sample sizes for these biocompatibility tests are not disclosed but would follow standard biological test protocols. Provenance or specific subjects are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For physical and biocompatibility testing of medical gloves, ground truth is established by standardized test methods and laboratory analysis, not by human expert consensus or interpretation in the way it is for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is not applicable to the non-clinical testing of examination gloves. Test results are objective measurements against a standard.
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
N/A. This device is an examination glove; it does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is an examination glove; it is not an algorithm and does not have standalone performance in the context of AI.
7. The type of ground truth used
For physical and dimensions testing, watertight testing, and residual powder testing, the "ground truth" is defined by the numerical specifications and limits set by the applicable ASTM and FDA standards (e.g., ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06). For primary skin irritation and skin sensitization, the "ground truth" is established by biocompatibility test guidelines that determine the absence of adverse biological reactions.
8. The sample size for the training set
N/A. This device does not involve a "training set" in the context of machine learning or complex model development. The manufacturing process of gloves is subject to quality control, but not a "training set" in this sense.
9. How the ground truth for the training set was established
N/A. See 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.