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510(k) Data Aggregation
(402 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
The provided text describes the acceptance criteria and the study results for the "Nitrile Patient Examination Gloves, Powder Free, Pink Color" manufactured by Shandong YINGHONG Medical Products Co., Ltd.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Dimensions (length, width, thickness) (ASTM D6319-19) - To evaluate the physical dimension of the glove | Length: 220 mm min (XS, S); 230 mm min (M, L, XL, XXL) | Pass (240 mm min) |
| Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | Pass (XS: average 78.4mm; S: average 86.2mm; M: average 97.4mm; L: average 108.7mm; XL: average 115.5mm; XXL: average 123.5mm) | |
| Thickness(mm): Palm: Minimum 0.05; Finger: Minimum 0.05 | Pass (Palm - 0.056mm min.; Finger - 0.082mm min) | |
| Physical properties (ASTM D6319-19) - To evaluate the tensile strength and ultimate elongation before and after aging | Before Aging: Tensile Strength: 14 MPa, min.; Elongation: 500%, min. After Aging: Tensile Strength: 14 MPa, min.; Elongation: 400%, min. | Pass (Before Aging: Tensile Strength: 20.6MPa, min.; Elongation: 531%, min. After Aging: Tensile Strength: 21.9MPa, min.; Elongation: 416%, min.) |
| Freedom from holes (ASTM D5151-19) - To detect holes in the gloves | In accordance with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implicit in "Similar" comparison to predicate) | (The specific result for this test is not explicitly stated in the table provided for the subject device, but the comparison table indicates "Similar" to the predicate which met these standards) |
| Residual Powder (ASTM D6124-06) - To detect the powder residue in the glove | <2mg per glove | Pass (Average 0.15 mg per glove) |
| In Vitro Cytotoxicity Test (ISO 10993-5) - To determine the cytotoxic potential of the glove. | Under the conditions of the study, the device is not cytotoxic | Pass (Under the conditions of the study, the device have no cytotoxic effect) |
| Skin Sensitization Test (ISO 10993-10) - To determine the skin sensitization potential of the glove. | Under the conditions of the study, the device is not a sensitizer | Pass (Under the conditions of the study, the device is not a sensitizer.) |
| Skin Irritation Test (ISO 10993-10) - To determine the potential of the glove under test to produce irritation. | Under the conditions of the study, the device is not an irritant | Pass (Under the conditions of the study, the device is not an irritant.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical physical and biocompatibility testing. It cites compliance with ASTM and ISO standards for these tests. For these types of tests, specific sample sizes beyond what the standards prescribe are usually not detailed in the summary. For example, ASTM D6319-19 and ASTM D5151-19 would define the sampling plans. The document mentions "Three Lot" for the residual powder test, suggesting at least three batches were sampled.
The data provenance is from the manufacturer, Shandong YINGHONG Medical Products Co., Ltd., which is located in Qingzhou, Shandong, China. The studies are prospective as they are conducted for the specific purpose of device submission and evaluation against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a patient examination glove and the tests performed are physical and biocompatibility evaluations against established industry standards (ASTM, ISO). These do not involve human interpretation or expert-established ground truth in the way medical imaging or diagnostics might. The "ground truth" is defined by the objective measurement specifications of the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3. Physical and biocompatibility tests are objective and do not typically involve 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
This information is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is an examination glove, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is based on established industry standards and regulatory specifications as outlined in ASTM D6319-19, ASTM D6124-06, ASTM D5151-19, ISO 10993-10, and ISO 10993-5. This is objective and measurable, rather than relying on expert consensus or pathology in a clinical diagnostic sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of physical and biocompatibility testing of a medical device like an examination glove. These tests are direct evaluations against performance criteria.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device and testing.
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