(38 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 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 800.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, structured as requested:
Device: Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM Standard D5250-92 | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0." |
| FDA 1000 ml. Water Fill Test requirements (Pinhole integrity) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements." |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization) | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| "Powder-free" claim (USP Iodine Test for Starch) | "A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims. We adhere to all USP Iodine test methodology and testing conducted revealed passing results." |
| General controls provisions of the Medical Device Amendments (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) | The FDA's 510(k) clearance letter states, "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device is deemed to comply or is expected to comply with these provisions. |
Study Details:
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Sample size used for the test set and the data provenance:
- ASTM D5250-92 Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
- FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level S-4." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
- Primary Skin Irritation and Skin Sensitization Testing: Not explicitly stated.
- USP Iodine Test for Starch: Not explicitly stated.
- Data Provenance: The document implies in-house testing conducted by Shijiazhuang Dilly Plastics Products Co., Ltd. in P.R. China, presumably on newly manufactured gloves. This would be considered prospective for the specific batches tested.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes performance against established industry standards (ASTM D5250-92) and FDA test methods (1000 ml. Water Fill Test, USP Iodine Test), as well as biocompatibility testing. It does not mention expert consensus for establishing ground truth in the context of diagnostic interpretation. Ground truth for these criteria is defined by the objective pass/fail parameters outlined in the respective standards and test methodologies.
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Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1) is mentioned as this is not a study involving subjective interpretations (e.g., image reading). The tests are objective measurements against defined criteria in standards.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical examination glove, not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical product and does not involve an algorithm.
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The type of ground truth used:
- The ground truth for the performance criteria is based on objective, standardized measurements and pass/fail criteria defined by ASTM D5250-92, FDA test methods (e.g., 1000 ml. Water Fill Test, USP Iodine Test), and general biocompatibility testing protocols.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" here would be for the manufacturing process to consistently produce compliant gloves.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI sense. The manufacturing process is designed and controlled to 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.