(33 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 880.6250, Powder Free Vinyl Patient Examination Glove, 801.YZ, and mects all requirements of ASTM Standard D5250-00 4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves:
Device: Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| (Based on ASTM D5250-00 4) | Meets requirements. Inspection Level S-2, AQL 4.0. |
| Freedom from Holes (FDA 1000ml. Water Fill Test): | |
| (Based on ASTM D5151-99) | Meets requirements. Samplings of AQL 2.5, Inspection Level I. |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder Test (for "Powder Free" claim): | |
| (Based on ASTM D6124-01 for Starch) | Meets "Powder Free" claims (contains no more than 2mg powder per glove). |
| Biocompatibility Requirements: | Meets requirements (implied by no skin irritation/sensitization and overall conclusion). |
| Labeling Claims (General): | No special labeling claims (e.g., hypoallergenic). |
2. Sample size used for the test set and the data provenance:
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Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but AQL 4.0 implies a statistically determined sample based on lot size).
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Freedom from Holes (Water Fill Test): Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but AQL 2.5 implies a statistically determined sample based on lot size).
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Primary Skin Irritation and Skin Sensitization: The text does not specify the sample size for these tests.
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Residual Powder Test: Not specified.
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Data Provenance: The tests were performed by the manufacturer, Grand Work Plastics Products Co., Ltd., presumably in P.R. China, where the company is located. The tests are "Non-Clinical tests," implying they were conducted in a laboratory or similar controlled environment. The data is retrospective in the sense that it was generated for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a Class I medical device (patient examination glove) and the testing described is primarily laboratory-based performance testing and biocompatibility.
- No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for these tests is based on objective measurements against established ASTM standards and FDA requirements (e.g., water leak test, dimensional measurements, chemical analysis for powder, and animal/in vitro biocompatibility tests for skin irritation/sensitization).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving reader interpretation (e.g., radiology AI). This submission concerns a physical medical device and its performance against technical specifications and biocompatibility, not diagnostic accuracy requiring human reader adjudication. The results are objective measurements.
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:
- No. This type of study (MRMC comparative effectiveness) is not applicable to an examination glove. It is primarily used for diagnostic devices, especially those incorporating AI, where human readers interpret medical images or data. The device in question is a physical barrier intended for infection control.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI-based system. It is a physical product.
7. The type of ground truth used:
- Objective measurements against established standards and laboratory test results.
- For physical and dimensional testing: ASTM D5250-00 4.
- For freedom from holes: FDA 1000ml. Water Fill Test based on ASTM D5151-99.
- For biocompatibility (skin irritation and sensitization): Laboratory test results (the specific methods like ISO standards for biocompatibility are not explicitly cited but are implied by the "no primary skin irritant or sensitization reactions" statement).
- For residual powder: ASTM D6124-01.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this product, as it is not an AI/machine learning device. The testing described focuses on product quality control and performance verification against established standards for manufacturing.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.