(28 days)
A patient examination glove 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 disposable device intended for medical a purpose 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, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00.
The provided 510(k) summary is for a medical device that is a Synthetic Powder Free Vinyl Patient Examination Glove. This type of submission, especially for Class I devices like examination gloves, typically relies on established performance standards rather than complex clinical studies involving human readers or AI.
Therefore, many of the requested categories regarding AI, human readers, ground truth for training sets, etc., are not applicable to this specific submission. The submission focuses on demonstrating that the new device meets recognized industry standards and is substantially equivalent to a predicate device.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00, Inspection Level S-2, AQL 4.0 | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. (General statement of compliance) |
| Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, Inspection Level I | The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. |
| Primary Skin Irritation | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | Testing conducted with results showing no sensitization reactions. |
| Residual Powder Test (for "powder-free" claim): ASTM D6124-97, no more than 2 mg powder per glove | A Residual Powder Test that based on ASTM D6124-97 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove). (Statement of compliance with the 2 mg/glove limit implied) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
- For FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
- For Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified but typically involves a set number of animal or in vitro tests according to ISO 10993 standards.
- For Residual Powder Test: Not specified but would be a sampling from production batches.
- Data Provenance: The tests are described as being "conducted" in relation to the manufacturer (Shijiazhuang Eversharp Plastics Products Co., Ltd. in China), indicating the data provenance is likely internal testing performed by or for the manufacturer. The date of "May 11, 2001" for the summary indicates a retrospective nature relative to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical product (gloves) and its performance is assessed against standardized physical, chemical, and biological tests, not against diagnostic "ground truth" established by human experts in the way AI algorithms are evaluated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, the evaluation is based on objective measurements and adherence to established standards, not on human interpretation or adjudication methods.
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 is not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is derived from established industry standards and regulatory test methods. For example:
- Physical performance: Defined by ASTM-D-5250-00 (e.g., tensile strength, elongation, dimensions).
- Barrier integrity: Defined by the FDA 1000 ml. Water Fill Test (pinhole detection).
- Biocompatibility: Defined by primary skin irritation and skin sensitization tests (aligned with ISO 10993 principles, though not explicitly stated as such, it's the standard for these tests).
- Powder content: Defined by ASTM D6124-97.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the manufacturing process would be related to quality control and process validation, not data used to train an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set in the context of an AI algorithm, this question is not relevant. The "ground truth" for manufacturing quality and consistency is established through adherence to Good Manufacturing Practices (GMP) and quality system regulations (such as 21 CFR Part 820), which ensure consistent product quality, but this is distinct from ground truth for an AI training set.
§ 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.