(75 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 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 Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided text describes the 510(k) summary for the "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color."
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets all requirements of ASTM Standard D5250-06 for Physical and Dimensions Testing (Inspection Level S-2, AOL 2.5) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5. |
| Meets FDA 1000 ml. Water Fill Test requirements (AQL 2.5, Inspection Level I) | The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements. |
| No primary skin irritant reactions in Primary Skin Irritation testing | Primary Skin irritation testing was conducted with results showing no primary skin irritant reactions. |
| No sensitize reactions in Skin Sensitization (allergic contact dermatitis) testing | Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitize reactions. |
| Meets "powder-free" claims (contain no more than 2 mg powder per glove) | Conducted to insure that our gloves meet our "overder-free" claims (contain no more than 2 mg powder per glove). |
| Conforms to applicable 21 CFR references (e.g., 21 CFR 880.6250) | Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free, yellow color conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references. |
| Meets pinhole FDA requirements | Meets pinhole FDA requirements. |
| Meets biocompatibility requirements | Meets biocompatibility requirements. |
| Meets labeling claims | Meets labeling claims as shown by data in Section 7. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "samplings of AQL 2.5" and "Inspection Level S-2, AOL 2.5" for various tests. These are Acceptable Quality Limit (AQL) levels and Inspection Levels specified in quality control standards (like ASTM). While they define the statistical sampling plan (how many gloves are inspected from a lot and how many defects are allowed), they do not explicitly state the total number of gloves (sample size) actually tested for each criterion. The general practice for such tests involves taking samples from production lots.
- Data Provenance: The tests were conducted internally by Zibo Yingbo Medical Products Co., Ltd. or contracted labs on their behalf, adhering to established standards (ASTM, FDA). The provenance is specific to the manufacturer's testing of their product. No external country of origin or retrospective/prospective nature of data is mentioned beyond the manufacturing location (China) and the date the summary was prepared (Feb. 10, 2010), indicating the tests pre-date this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device. Patient examination gloves are class I devices where performance is measured through objective physical, chemical, and biological tests based on recognized standards, not subjective expert interpretation of images or patient data. The "ground truth" is defined by passing the specified thresholds in ASTM and FDA test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation by multiple human readers (e.g., radiologists) is involved in determining a "ground truth" for a diagnostic algorithm. For gloves, tests are objective and follow defined protocols, so no multi-reader adjudication is necessary.
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 is not applicable. The device is a physical product (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these gloves is established by:
- Standard Specifications: Meeting predefined physical properties (e.g., tensile strength, elongation), dimensional tolerances, and leakage resistance as outlined in ASTM D5250-06.
- Biocompatibility Standards: Demonstrating the absence of significant irritation or sensitization through specific biological tests, where "ground truth" is defined by the absence of a reaction according to test protocols.
- Chemical Analysis: Confirming the "powder-free" claim through quantitative measurement of powder content (e.g., less than 2 mg per glove).
These are all objective, measurable criteria defined by established industry and regulatory standards.
8. The sample size for the training set:
This is not applicable. This is a product that undergoes manufacturing and quality control testing, not an AI model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable. 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.