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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.

This document is a 510(k) clearance letter for medical examination gloves. It is not a document describing a study for a medical device that uses AI or requires expert ground truth. Therefore, I cannot provide the requested information.

The prompt specifically asks for details related to:

• A table of acceptance criteria and device performance for an AI/ML device.
• Sample sizes for test and training sets (relevant to AI/ML).
• Number and qualifications of experts for ground truth (relevant to AI/ML).
• Adjudication methods (relevant to AI/ML).
• MRMC studies (relevant to AI/ML).
• Standalone algorithm performance (relevant to AI/ML).
• Type of ground truth used (relevant to AI/ML).
• How ground truth was established for training (relevant to AI/ML).

The provided text discusses the non-clinical performance testing of rubber examination gloves. The "acceptance criteria" and "results" tables in the document pertain to physical and chemical properties of gloves (e.g., length, width, thickness, tensile strength, protein content, biocompatibility) tested against established ASTM and ISO standards for medical gloves.

There is no mention of an algorithm, AI, machine learning, human-in-the-loop performance, or expert review for diagnostic purposes. The "ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established industry standards, not expert interpretations of medical images or data.

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The Powder Free Natural Rubber Latex Examination Gloves is a single use disposable device intended for medical purposes that is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of ASTM Specification D3578-05(2010) Standard Specification for Rubber Examination Gloves standard.

The provided text describes the acceptance criteria and the device performance, but does not contain a study designed to prove the device meets these criteria in the typical sense of a clinical or analytical study. Instead, the document is a 510(k) summary for a medical device (examination gloves), which establishes substantial equivalence to existing legally marketed devices based on non-clinical performance standards.

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

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

Note regarding other criteria: The "Substantial Equivalence Comparison" table in section 9.0 also lists several characteristics with specific numerical requirements (e.g., Width, Length, Thickness, Tensile Strength, Elongation, Protein Content, Freedom from Holes). For the "Medtexx Manufacturing Sdn. Bhd." device, these are stated as meeting or passing the relevant ASTM or 21 CFR standards. For example:

• Width (Size Medium): Meets ASTM D 3578-05(2010): XS - 70 ± 10, S - 80 ± 10, M - 95 ± 10, L - 111 ± 10
• Overall length: Length ≥ 240mm
• Palm thickness: 0.08mm
• Finger thickness: 0.08mm
• Tensile Strength per aging min.: 18.0 MPa
• Tensile Strength after aging min.: 14.0 MPa
• Ultimate elongation pre aging min.: 650%
• Ultimate elongation after aging: 500%
• Residual powder test: Passes (meets applicable definition for Powder Free; $\le$ 2 mg per glove)
• Freedom from Holes: Meets Requirements per 21CFR800.20: Gloves Free of Holes at quality level of AQL 1.5
• Protein Content: Meets Applicable Definition for Protein Content; $\le$ max 50 (ug/dm²)
• Skin irritation: Passes
• Dermal sensitization: Passes

Study Details

The document states that "Clinical data is not needed for gloves or most devices cleared by the 510(k) process." This indicates that a traditional clinical study to "prove the device meets the acceptance criteria" was not conducted or required. Instead, the device's performance is demonstrated through compliance with established industry standards (ASTM, ISO) and FDA regulations (21 CFR). The basis for clearance is the "Substantial Equivalence" of the device to existing predicate devices, as shown by non-clinical performance data (i.e., laboratory testing against standards).

Given this, the following points address the specific questions based on the provided text, primarily indicating that these types of studies were not performed or are not applicable in this 510(k) context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not explicitly stated in the provided text. The document refers to "performance test data of non-clinical tests" but does not detail the sample sizes for these tests (e.g., how many gloves were tested for dimensions, physical properties, watertightness, biocompatibility, etc.).
• Data provenance: The submitting company, Worldmed Manufacturing Sdn. Bhd., is located in Malaysia. It is implied that the testing would have been conducted or overseen by the manufacturer or a contracted testing facility. The data itself would be considered retrospective in the sense that the tests were performed on manufactured glove samples to demonstrate compliance with standards 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 (e.g. radiologist with 10 years of experience)

• Not applicable. For this type of device (examination gloves), ground truth is established by adherence to engineering and performance standards (e.g., ASTM, ISO, FDA regulations) as measured in laboratory settings, not by expert consensus on clinical observations. Therefore, no "experts" in the sense of clinical reviewers establishing ground truth are mentioned or required.

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

• Not applicable. Adjudication methods are typically relevant for studies where human interpretation or subjective assessment of data (e.g., medical images, clinical outcomes) is involved. The testing described for examination gloves involves objective physical and chemical measurements against predefined standards.

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. MRMC studies are used for evaluating diagnostic aids, especially in imaging, by comparing human readers' performance with and without assistance from a device. This is a very different type of device (examination gloves) where such a study design is irrelevant.

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

• Not applicable. This device is an examination glove, not an algorithm or a diagnostic tool that would have "standalone" performance in the context of AI or interpretive systems. Its performance is inherent to its physical and material properties.

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

• The "ground truth" for this device is the defined specifications and limits within the referenced national and international standards (ASTM D3578-05(2010), ISO 10993-10:2002/Amd 1:2006(E), 21 CFR 800.20). Performance is judged by whether the device's measured characteristics meet these established engineering and material science criteria.
• For biocompatibility, the "ground truth" is established by laboratory tests for irritation and sensitization, with "Pass" indicating no adverse biological reactions as defined by the ISO standard.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As there is no training set for this device.

In summary: The provided text details how the examination gloves meet established engineering and biocompatibility standards through non-clinical laboratory testing. The basis for FDA clearance is "substantial equivalence" to predicate devices, not a clinical study proving effectiveness or safety in human subjects.

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Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use 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.

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Less Protein is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-051, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves And Protein Labeling Claim of 50 Micrograms or Less Protein":

This document describes a 510(k) premarket notification for a medical device (examination gloves). The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the "study" referenced here is largely non-clinical testing to meet established standards.

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

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for ASTM D3578, or how many rabbits/guinea pigs were used).

• Provenance: The manufacturing country is Malaysia (Latexx Manufacturing Sdn. Bhd., PT 5054, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia). The testing described appears to be retrospective as it's a pre-market submission demonstrating compliance with existing standards.

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

Not applicable. This is not a study requiring expert consensus for "ground truth" in the typical sense of a diagnostic or interpretive device. The "ground truth" here is adherence to established engineering and biocompatibility standards, and the results of laboratory tests.

4. Adjudication method for the test set

Not applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for these types of engineering and biocompatibility tests.

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 is not a diagnostic device or an AI-enabled device. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was performed. The device is an examination glove.

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. It is a physical medical device (gloves).

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

The ground truth for this device is based on:

• Established engineering standards: ASTM D 3578-051 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with powder on surgeon's gloves and examination gloves).
• Biocompatibility testing results: Primary skin irritation and delayed contact sensitization tests.
• Chemical tests: USP Iodine test for starch.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

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