(119 days)
A patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between 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 upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
This is not a medical device that utilizes AI/ML. The provided text describes a 510(k) submission for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.
The acceptance criteria and study detailed in the document pertain to the physical properties, biocompatibility, and regulatory compliance of these medical gloves, not to the performance of an AI/ML powered device.
Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for training/test sets, expert qualifications, or MRMC studies, as these concepts are not applicable to the device described.
However, I can extract the relevant information for the glove device based on the provided text:
Acceptance Criteria and Reported Device Performance for Tangshan Jiteng Plastic Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Physical and Dimensions | ASTM Standard D6319-05 | Meets all requirements | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5. |
| Pinhole (Barrier Integrity) | FDA 1000 ml. Water Fill Test | Meets requirements | Conducted with samplings of AOL 2.5, Inspection Level I. |
| Biocompatibility | Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing | No primary skin irritant or sensitization reactions | Testing was conducted with results showing no primary skin irritant or sensitization reactions. |
| Powder Content | No more than 2 mg powder per glove ("powder-free" claim) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) | Testing conducted to ensure that gloves meet "powder-free" claims. |
| Regulatory Compliance | 21 CFR 880.6250, 80LYZ (Class I Device, Powder-Free Nitrile Patient Examination Glove) | Conforms fully to ASTM-D-6319-05 standard and applicable 21 CFR references | Data in Section 7 (Discussion of Non-Clinical tests) |
Regarding the other requested points, they are not applicable to this medical glove device:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "samplings of AOL 2.5, Inspection Level I" and "Inspection Level S-2, AOL 2.5" for physical testing and water fill tests, which refers to Acceptable Quality Levels (AQL) for manufacturing quality control, not a sample size for an AI/ML test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove involves standardized physical and chemical tests, not expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device is based on standardized testing protocols and ASTM standard specifications (ASTM-D-6319-05) for physical properties, barrier integrity (water leak test), and biocompatibility.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML 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.