(14 days)
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 as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4
The provided text describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic (Blue) Vinyl Patient Examination Gloves-Powder Free.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4, 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." The device "conform[s] fully to ASTM-D-5250-00E4 standard." |
| Pinhole Detection (Water Fill Test): Based on ASTM D-5151-99, samplings of AQL 2.5, Inspection Level I | "The FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements." The device "meets pinhole FDA requirements." |
| Primary Skin Irritation | "Primary Skin irritation...testing was conducted with results showing no primary skin irritant reactions." |
| Skin Sensitization (Allergic Contact Dermatitis) | "…Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions." The device "meets biocompatibility requirements." |
| Residual Powder: Based on ASTM D6124-01, not more than 2 mg powder per glove (for "powder-free" claim) | "A Residual Powder Test that based on ASTM D6124-01 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)." |
| General Device Classification/Compliance: Class I, 21 CFR 880.6250, 80LYZ | "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 D5250-00E4." The device "conform[s] fully to...applicable 21 CFR references." |
| Labeling Claims | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." The device "meets...labeling claims." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific numerical sample size for the entire "test set." However, it mentions:
- For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (AQL refers to Acceptance Quality Limit, a statistical sampling method for quality control, not a fixed sample size).
- For Water Fill Test: "samplings of AQL 2.5, Inspection Level I" (similar to above, a statistical sampling method).
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd. Given the company's location, the data provenance would be from China. The studies are retrospective in the sense that they are conducted on finished products for quality control and regulatory 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 as the device is a medical glove, and its performance is evaluated against engineering and material standards, not by expert interpretation of complex medical data.
4. Adjudication method for the test set
Not applicable for this type of device and testing. Performance is measured against objective physical and chemical standards.
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 device is a passive medical product (gloves) and does not involve AI or human "readers" in its function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The "standalone" performance refers to the device's physical and chemical properties as measured in the non-clinical tests.
7. The type of ground truth used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM Standard D5250-00E4 (for general glove properties, physical, and dimensions)
- ASTM D-5151-99 (for pinhole detection via water fill test)
- ASTM D6124-01 (for residual powder measurement)
- Biocompatibility standards (for primary skin irritation and sensitization)
- 21 CFR 880.6250 and other applicable 21 CFR references (for regulatory classification and compliance)
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.