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510(k) Data Aggregation
(22 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.
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 requirement of ASTM Standard D5250-00.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.
This document describes the acceptance criteria and studies conducted for the Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Meets ASTM-D-5250-00 requirements, Inspection Level S-2, AQL 4.0. | The device meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0, based on ASTM-D-5250-00. |
| Pinhole Test (FDA 1000 ml Water Fill Test): Meets requirements for AQL 2.5, Inspection Level I. | The FDA 1000 ml Water Fill Test was conducted with samplings of AQL 2.5, Inspection Level I, and the device met these requirements. |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization): No primary skin irritant or sensitization 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 Test (for "powder-free" claim): Contains no more than 2 mg powder per glove (based on ASTM D6124-97). | A Residual Powder Test based on ASTM D6124-97 for Starch at finished inspection was conducted, ensuring the gloves meet the "powder-free" claim (containing no more than 2 mg powder per glove). |
| General Conformance: Conforms fully to ASTM-D-5250-00 standard and applicable 21 CFR references. | The device conforms fully to ASTM-D-5250-00 standard as well as applicable 21 CFR references. |
| Labeling Claims Conformance: Adherence to labeling claims (no special claims, not hypoallergenic). | There are no special labeling claims, and the gloves are not claimed as hypoallergenic. The device meets "labeling claims as shown by data in Section 7." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- Physical and Dimensions Testing: The sample size is implicitly defined by "Inspection Level S-2, AQL 4.0" as per ASTM-D-5250-00, but a specific number is not provided.
- Pinhole Test: The sample size is implicitly defined by "AQL 2.5, Inspection Level I" as per the FDA 1000 ml Water Fill Test, but a specific number is not provided.
- Biocompatibility (Skin Irritation/Sensitization): Not specified.
- Residual Powder Test: Not specified.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., based in Luquan, Hebei Province, P.R. China, implying the data originated from China. The nature of the tests (manufacturing quality control, laboratory testing) suggests they are prospective in nature, performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are objective, quantitative measurements (e.g., physical dimensions, water fill test, chemical analysis for powder, biological response in irritation tests) rather than subjective assessments requiring expert consensus for ground truth.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established standards, not requiring multi-reader adjudication.
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 patient examination glove, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for performance validation is defined by:
- Established ASTM Standards: ASTM-D-5250-00 for physical characteristics and dimensions, and ASTM D6124-97 for residual powder.
- FDA Requirements: Specific FDA requirements for pinhole testing (1000 ml Water Fill Test).
- Biocompatibility Testing Protocols: Standard methods for primary skin irritation and sensitization testing.
These are all objective, quantitative, and standardized criteria.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model, 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, this question is not relevant.
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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 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 (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
This is a 510(k) summary for a medical device that is a Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Glove. This submission is for a Class I medical device, which generally means it poses a lower risk to patients and users and often relies on established performance standards rather than extensive clinical studies for approval.
The document describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the way one might describe for an AI/ML digital health product or more complex diagnostic device. For this type of glove device, acceptance criteria are tied to manufacturing standards and physical properties.
Here's the breakdown of the information requested, tailored to what's available for this specific medical device submission:
| Information Requested | Details for Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | |
| Acceptance Criteria | Reported Device Performance |
| ASTM-D-5250-92 Standard Compliance (Physical and Dimensions Testing) | 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 (Pinhole integrity) | Samplings of AQL 2.5, Inspection Level S-4, met requirements. |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization) | Results showing no primary skin irritant or sensitization reactions. |
| Powder-Free Claim (USP Iodine Test for Starch) | Revealed passing results, adhering to USP Iodine test methodology. |
| 2. Sample size for test set and data provenance | The document does not specify a distinct "test set" sample size in the context of an AI/ML study. For the physical and performance tests, "samplings" were taken from production, with "Inspection Level S-2, AQL 4.0" for physical and dimensions, and "AQL 2.5, Inspection Level S-4" for the water fill test. This refers to statistical sampling plans used in quality control. The data provenance is implied to be from the manufacturer's internal testing as part of their production and quality assurance processes (China). The study is retrospective in the sense that these are manufacturing quality control tests conducted on finished products. |
| 3. Number of experts used to establish ground truth & qualifications | For this device (patient examination gloves), "ground truth" is established through standardized laboratory tests and adherence to established material and performance specifications (ASTM standards, FDA water fill test, USP tests). There isn't a team of human "experts" establishing a diagnostic ground truth in the way described for AI/ML. The "experts" are the laboratory technicians and quality control personnel performing the defined tests and interpreting the results against the established standards. No specific number or qualifications are provided beyond the implicit expertise in conducting these standard tests. |
| 4. Adjudication method for the test set | Not applicable in the context of diagnostic performance. Quality control for manufacturing relies on standardized test methods with pass/fail criteria. There isn't an "adjudication method" involving multiple human readers as in clinical image interpretation. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | Not applicable. This is for a physical medical device (examination gloves), not an AI/ML system or diagnostic tool where human readers' performance would be evaluated. |
| 6. Standalone (algorithm only) performance study | Not applicable. This is for a physical medical device (examination gloves). There is no algorithm. |
| 7. Type of ground truth used | The ground truth is based on established industry standards and regulatory testing protocols: - ASTM Standard D5250-92 (for physical and dimensional properties) - FDA 1000 ml. Water Fill Test (for pinhole integrity) - Biocompatibility testing (Primary Skin Irritation and Skin Sensitization tests) - USP Iodine Test (for powder-free claim verification). |
| 8. Sample size for the training set | Not applicable. This is for a physical medical device, not an AI/ML system requiring a training set. |
| 9. How the ground truth for the training set was established | Not applicable. This is for a physical medical device. |
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