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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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(190 days)
Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.
The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, Powder Free. It demonstrates the substantial equivalence of the proposed device to a legally marketed predicate device (Primus Nitrile Examination Gloves, K143477).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nitrile Patient Examination Gloves, Powder Free (Lalan Rubbers (Pvt) Ltd)
| Characteristic | Acceptance Criteria (Predicate Device / ASTM D6319) | Reported Device Performance (Nitrile Patient Examination Gloves, Powder Free) |
|---|---|---|
| Physical Characteristics: | ASTM D6319 requirements | Meets ASTM D6319 requirements |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (XS) | $70 \pm 10$ | $\leq 80$ |
| Palm width (S) | $80 \pm 10$ | $85 \pm 5$ |
| Palm width (M) | $95 \pm 10$ | $95 \pm 5$ |
| Palm width (L) | $110 \pm 10$ | $105 \pm 5$ |
| Palm width (XL) | $120 \pm 10$ | $\geq 110$ |
| Thickness (Finger) | Minimum 0.05mm | $0.09 \pm 0.01$mm |
| Thickness (Palm) | Minimum 0.05mm | $0.07 \pm 0.01$mm |
| Thickness (Cuff) | Not explicitly defined (implied by ASTM) | $0.05 \pm 0.01$mm |
| Physical Properties: | ASTM D6319 requirements for tensile strength and ultimate elongation | Meets ASTM D6319 requirements |
| Tensile Strength (Before Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Tensile Strength (After Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Ultimate Elongation (Before Aging) | Minimum 500% | Minimum 500% |
| Ultimate Elongation (After Aging) | Minimum 400% | Minimum 400% |
| Freedom from holes: | ASTM D6319 requirements of GI, AQL 2.5 | Meets ASTM D6319 and ASTM D5151 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319 requirements; Not more than 2.0mg/glove | Meets applicable requirement for powder free; $\leq$ 2 mg per glove |
| Biocompatibility: | ASTM and ISO standards | - |
| Skin Irritation Test | Not an irritant (Under predicate study conditions) | Under the conditions of the study, not an irritant (ISO10993-23:2021) |
| Skin Sensitization Test | Not a sensitizer (Under predicate study conditions) | Under the conditions of the study, not a sensitizer (ISO 10993-10:2010) |
| In Vitro Cytotoxicity | Not explicitly stated for predicate | Diluted concentrations 12.5% and 6.25% are not cytotoxic. Undiluted extract (100%), diluted concentrations 50% & 25% are cytotoxic. (ISO 10993-5:2009) |
| Acute Systemic Toxicity | Not explicitly stated for predicate | Under the conditions of the study, no evidence of systemic toxicity (ISO 10993-11: 2017) |
| Shelf Life | 3 years | 3 years (EN, 455-4:2009) |
2. Sample size used for the test set and the data provenance
The document specifies that non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The sample sizes for each specific test (e.g., number of gloves for physical testing, number of samples for biocompatibility) are not explicitly provided in this summary document. However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes and methodologies.
The "data provenance" (country of origin, retrospective/prospective) is not detailed for the test samples, but the tests were performed by Lalan Rubbers (Pvt) Ltd in Sri Lanka, which is the manufacturer. The tests are prospective in nature, as they involve testing newly manufactured devices against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device (Nitrile Patient Examination Gloves) does not involve expert interpretation or clinical diagnosis that would require human "ground truth" establishment in the typical sense of AI/clinical decision support systems. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM D6319, ISO 10993 series). Therefore, there were no "experts" establishing a subjective ground truth for a test set in this context. The acceptance criteria are quantitative and based on published standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is objective measurement against established physical and chemical standards. There is no subjective interpretation requiring 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 medical glove, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are for the physical, chemical, and biological properties of the glove itself.
7. The type of ground truth used
The ground truth used for this device's performance evaluation against acceptance criteria is objective measurement against recognized international standards and specifications. Specifically:
- Physical and Dimensional Properties: ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- Freedom from holes: ASTM D6319 and ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Powder Residual: ASTM D6319 and ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Biocompatibility: ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 10993-5 (Biological evaluation of medical devices for irritation, sensitization, systemic toxicity, and cytotoxicity)
- Shelf Life: EN 455-4:2009 (Medical gloves for single use Part 4: Requirements and testing for shelf life determination)
8. The sample size for the training set
Not applicable. This product is not an AI/machine learning model, so there is no concept of a "training set" in this context. The design and manufacturing process for the gloves are developed based on general engineering and material science principles, and then verified through the non-clinical tests mentioned.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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