Search Results

The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Single-Use Latex Sterile Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.

This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two tables relevant to acceptance criteria and device performance:

Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.

Table 2: Characteristics Comparison including Acceptance Criteria and Performance (This table on pages 6-8 directly addresses performance against standards)

2. Sample size used for the test set and the data provenance

The document specifies non-clinical tests were conducted according to various ASTM and ISO standards (pages 9-10). These standards define sample sizes for specific tests (e.g., AQL for holes, specific number of samples for physical properties, etc.). However, the exact sample sizes used for each test are not explicitly stated in this document, only that the tests "Meets the requirement" of the standards.

The data provenance is from non-clinical testing performed on the "Subject device K231446", which is a prospective test for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is Fitone Latex Products Co., Ltd. Guangdong, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a physical product (surgical gloves) and the performance criteria are based on objective measurements defined by international standards (ASTM, ISO, USP). Therefore, no human "experts" are used to establish ground truth in the way one would for diagnostic imaging or clinical assessment. The "ground truth" is the established technical specification in the referenced standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for objective physical/chemical testing per standards, not for subjective assessments 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 surgical glove, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance of the surgical gloves is based on international consensus standards and specifications (ASTM D3577-19 for physical properties, ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D5712-15 for protein content, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization, and USP standards for bacterial endotoxin and pyrogenicity). These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

Not applicable. This is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.

Warning: Please do not use with Carmustine and Thio Tepa.

The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)

The document describes the non-clinical testing performed to demonstrate that the Nitrile Patient Examination Gloves (K221747) meet their acceptance criteria and are substantially equivalent to a predicate device (K211220).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for each specific test within the non-clinical testing. It generally refers to "Final finished product" as the tested sample. The data provenance is not specified, but it can be inferred that the testing was conducted by or on behalf of the manufacturer, Fitone Latex Products Co., Ltd. Guangdong, which is based in China. The nature of the tests (physical, chemical, and biocompatibility) suggests these were laboratory-based tests on manufactured product samples. The document does not indicate if the data is retrospective or prospective, though it is standard practice for such tests to be prospective assessments of newly manufactured products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the tests described are non-clinical, objective measurements against established ASTM and ISO standards for material properties and performance. There is no human interpretation or expert ground truth establishment for these types of tests (e.g., measuring glove dimensions, tensile strength, or chemical permeation).

4. Adjudication method for the test set:

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.

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 submission is for a medical glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance comparison was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable as the device is not an algorithm or AI-based system.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is based on established industry standards and specifications:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06(2017) (Test Method for Residual Powder on Medical Gloves)
• ASTM D573-04(2019) (Test Method for Rubber-Deterioration in an Air Oven)
• ISO 10993-5: 2009 (Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10: 2010 (Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization)
• ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)

These standards define the acceptance criteria (e.g., minimum tensile strength, maximum residual powder, breakthrough times for chemotherapy drugs).

8. The sample size for the training set:

This information is not applicable as there is no training set for a medical glove. These are physical products tested against predetermined specifications.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set.

Ask a specific question about this device

The Single-use medical latex examination gloves 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.

The Single-use medical latex examination qloves 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. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.

The provided text describes the 510(k) premarket notification for a medical device: "Single-use medical latex examination gloves (LG100)". This document is not for an AI/ML-based medical device. Therefore, the questions related to AI/ML device testing (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K214017) through non-clinical performance testing against established ASTM and ISO standards for examination gloves.

Here's the relevant information based on the provided text, primarily focusing on the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance for Single-use Medical Latex Examination Gloves (LG100)

This device is not an AI/ML system, but rather a physical medical device (examination gloves). Therefore, the acceptance criteria and study data relate to physical, chemical, and biological properties of the gloves, not algorithmic performance.

1. A table of acceptance criteria and the reported device performance:

Note: The results for "In vitro Cytotoxicity" indicate "Failed (Potential toxicity Grade 3 or 4)", which seems to contradict the overall conclusion of the device being "as safe, as effective, and performs as well as or better than the legally marketed predicate device". This would warrant further investigation if this were a complete regulatory review. However, the provided text is the basis for this answer.

The following questions are not applicable to this 510(k) submission as it pertains to a physical medical device (examination gloves) and not an AI/ML-based device:

2. Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted according to published standards (e.g., AQL for water leak tests), not on subjective data sets. The testing is non-clinical, done by the manufacturer (Fitone Latex Products Co., Ltd. Guangdong, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by objective physical and chemical testing standards, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established international standards (ASTM, ISO) for physical, chemical, and biological properties of medical gloves (e.g., tensile strength, freedom from holes, protein content, cytotoxicity tests).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.

The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.

This document describes the FDA 510(k) clearance for "Nitrile examination gloves" (K211927). The clearance is based on substantial equivalence to a predicate device (K203593). The device is a non-sterile, powder-free, single-use examination glove made of nitrile rubber.

The key acceptance criteria for this device are defined by a set of ASTM and ISO standards, which dictate the physical properties, freedom from holes, powder residue, and biocompatibility of the gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of gloves tested for tensile strength, number of samples for biocompatibility). The studies are non-clinical (laboratory testing) and based on internationally recognized standards (ASTM, ISO). The data provenance is from the manufacturing site in Guangdong, China, as indicated by the submitter's address. The tests are prospective as they were performed to verify the device met specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the "ground truth" for these tests isn't established by human experts in the sense of clinical diagnosis (e.g., radiologists). Instead, the performance is measured against objective, validated scientific standards (ASTM, ISO) and laboratory methods. The "experts" would be the qualified laboratory personnel performing the standardized tests, but their number and specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

This is not applicable. The device performance is determined by meeting objective criteria defined in the referenced ASTM and ISO standards, not by an adjudication process typically used for human-reviewed data or clinical outcomes.

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 is not applicable. Nitrile examination gloves are a physical medical device, not a diagnostic AI/imaging product. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical glove, not an algorithm or AI.

7. The type of ground truth used

The "ground truth" for this device is based on objective, standardized measurements and laboratory tests defined by ASTM and ISO standards. This includes:

• Physical measurements: Dimensions (palm width, length, thickness) measured according to ASTM D6319-19 and ASTM D3767-03(2020).
• Performance testing: Freedom from holes (ASTM D5151-19), tensile strength and ultimate elongation before and after aging (ASTM D6319-19, ASTM D412-16, ASTM D573-04(2019)), and powder residual (ASTM D6124-06(2017)).
• Biocompatibility testing: Skin sensitization, skin irritation (ISO 10993-10: 2010), and in vitro cytotoxicity (ISO 10993-5: 2009).

8. The sample size for the training set

This is not applicable. There is no "training set" for physical medical devices like examination gloves. The testing is for validation of the final product specifications against established standards.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set for this type of device, the concept of establishing ground truth for a training set does not apply.

Ask a specific question about this device