(46 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment.
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 Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient as Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
The provided document describes the 510(k) summary for the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM D5250-92) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. |
| FDA 1000 ml. Water Fill Test | Conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Primary Skin Irritation | Results showing no primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | Results showing no sensitization reactions. |
| USP Iodine Test for Starch (Powder-Free Claim) | Adheres to all USP Iodine Test methodology and testing conducted revealed passing results, insuring the "powder-free" claim. |
| Biocompatibility requirements | Met (as stated in the conclusion). |
| Labeling claims (no hypoallergenic claim) | Met (no special labeling claims, no hypoallergenic claim). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test conducted. It mentions "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing, which are statistical sampling plans but don't provide a direct sample count. The tests were performed on gloves produced by Shijiazhuang Great Eagle Plastic Products Co., Ltd. in Shijiazhuang, He Bei Province, P.R. China. The data would be prospective, as it's generated during the production and testing of new devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable. The device is a medical glove, and its performance is evaluated against established technical standards (ASTM, FDA water fill, USP iodine test) and biocompatibility tests. These tests have objective criteria and do not rely on expert interpretation to establish "ground truth" in the way a diagnostic imaging device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable. As explained above, the tests performed on the gloves are objective and rely on direct measurements and observations against predefined pass/fail criteria, not on subjective expert consensus or 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 section is Not Applicable. The device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. The device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device, a medical glove, is defined by objective, measurable compliance with established international and regulatory standards and test methods:
- ASTM Standard D5250-92: This standard defines physical properties and dimensions for vinyl examination gloves. The "ground truth" is whether the glove's measured properties (e.g., tensile strength, elongation, dimensions) fall within the specified ranges.
- FDA 1000 ml. Water Fill Test: This test determines the watertight integrity (pinhole defects) of the gloves. The "ground truth" is a pass/fail outcome based on whether water leaks through the glove under specific conditions.
- Primary Skin Irritation and Skin Sensitization Testing: These are biological tests conducted to assess the biocompatibility of the glove material. The "ground truth" is the absence of observed irritation or sensitization reactions in test subjects/models.
- USP Iodine Test for Starch: This test objectively determines the presence or absence of starch, which is critical for a "powder-free" claim. The "ground truth" is a passing result indicating minimal or no starch.
8. The sample size for the training set
This section is Not Applicable. The device is a medical glove, not a machine learning model. Therefore, there is no "training set" in the context of AI. The described tests are for product verification and validation.
9. How the ground truth for the training set was established
This section is Not Applicable. As stated above, there is no training set for this type of 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.