(57 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, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.
Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Sterile Vinyl Glove (Clear & Yellow)" device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical and Dimensions | 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." |
| Pinhole/Water Leak | FDA 1000 ml. Water Fill Test based on ASTM D5151-99 (AQL 2.5, Inspection Level I) | "The FDA 1000 ml. Water Fill Test based on ASTM D5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements." |
| Primary Skin Irritation | No primary skin irritant reactions | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization | No sensitization (allergic contact dermatitis) reactions | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Residual Powder | No more than 2 mg powder per glove (based on ASTM-D6124-01 for Starch) | "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)." |
| Overall Standard Conformance | Conforms fully to ASTM D-5250-00 and applicable 21 CFR references | "Shijiazhuang Hongxiang Plstic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear& Yellow) conform fully to ASTM D-5250-00" standard as well as applicable 21 CFR references..." |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "samplings of AQL 2.5, Inspection Level I" for the water fill test and "Inspection Level S-2, AQL 4.0" for physical and dimensions testing. These are statistical sampling plans from ASTM standards, which define the number of units to be inspected from a lot and the maximum number of defects allowed for the lot to be accepted. However, the exact numerical sample size (e.g., how many gloves were tested in total for each test) is not explicitly stated.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Hongxiang Plastic Products Co., Ltd., presumably in China ("Shijiazhuang Hongxiang Plastic Products Co., Ltd. New High Technologies Industrial Zone Luquan City, Hebei, China"). The data is retrospective as it was collected before the 510(k) submission.
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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 medical glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert human interpretation or diagnosis.
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Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective measurements against engineering standards, there is no need for expert adjudication. The results are quantitative (e.g., pass/fail a water leak test, measure powder content).
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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 a medical device (a glove), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is assessed through direct physical and chemical testing.
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The type of ground truth used:
- Standardized Physical, Chemical, and Biological Tests. The ground truth is established by meeting predefined criteria set forth in recognized industry standards like ASTM D-5250-00, ASTM D5151-99, and ASTM D6124-01, as well as biocompatibility testing (primary skin irritation and sensitization).
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The sample size for the training set:
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This product is a physical device, not an AI model. Its manufacturing process is controlled to meet specifications, but there isn't a training dataset in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The manufacturing process is designed and verified to produce gloves that consistently meet the established performance standards.
§ 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.