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The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.

Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (containing a 100 micrograms or less of total water extractable protein per gram) and made from Allotex an Enzyme Treated Natural Rubber Latex.

I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a US FDA 510(k) clearance letter for "Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves". This type of letter primarily indicates that the device has been found substantially equivalent to a predicate device already on the market, meaning no new clinical studies proving performance against acceptance criteria are typically required or detailed in the clearance letter itself.

The letter focuses on regulatory compliance, legal marketing, and general controls. It does not contain information on:

• Specific acceptance criteria for device performance (e.g., tensile strength, elongation, barrier integrity, protein levels in a performance study context).
• Any studies conducted to prove the device meets such criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The closest relevant information is the "Protein Labeling Claim (containing a 100 micrograms or less of total water extractable protein per gram)", which is a device characteristic, but the document does not describe a study proving compliance with this specific limit.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or details about the study.

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The RubberCare powdered latex 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.

It is made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages to remove residual chemicals and water-soluble proteins. The extent of protein removal is within the limit of the ASTM D3578-01a24 recommended limits for both powder and water-soluble protein.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states these passed tests refer to "attachment H (page 19)" which is not included in the provided text, so specific criteria for these tests are not available here.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for testing each parameter. However, the data represents testing performed by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, located in Seremban, Negeri Sembilan, Malaysia. The data is retrospective in the sense that it was collected and then summarized for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of study (material properties testing for medical gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The acceptance criteria are established by the ASTM (American Society for Testing and Materials) standard D 3578-01a2, which represents a consensus of experts in the field of rubber products. The testing itself is performed by laboratory technicians following standardized procedures.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations, but rather laboratory testing against established specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (gloves) against established material and performance standards, not a diagnostic algorithm that would typically involve human readers.

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

Yes, this can be considered a "standalone" performance evaluation in the sense that the device's physical and chemical properties were tested in isolation against established standards, without human interaction influencing the measurement of these properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the ASTM D3578-01a2 standard specifications. These are industry-accepted, scientifically validated performance metrics for patient examination gloves.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The measurements presented are from a batch of manufactured gloves.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The ground truth (ASTM standards) is established through a consensus process by the ASTM organization, involving experts in the field.

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Ask a specific question about this device

Ask a specific question about this device

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

It is the powder-free variation of the class II latex patient examination gloves made by washing the gloves in a chlorine solution followed by an effective chemical removal and acid neutralization steps. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.

The device in question is a pair of Rubbercare Powder-Free/Guardian Powder-Free Latex Examination Gloves with a Protein Labeling Claim (50 micrograms or less).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: "n.a." for Protein, Skin Irritation, and Dermal Sensitization implies that these were specific claims or tests conducted without a direct numerical ASTM specification provided in the table, but the results were explicitly stated to "Pass" or meet a defined threshold (like "50 and below" for protein). The document explicitly states these "meet all the requirements of ASTM standard D 3578-99" and other FDA requirements.

The study conducted to prove the device meets these criteria is an internal product testing and evaluation process by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD. The results, as presented in the table, demonstrate the glove's compliance with the ASTM standard D 3578-99, FDA pinhole requirements, and the protein content labeling claim.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., how many gloves were tested for length, thickness, tensile strength, etc.). It provides ranges of "Measured Values" which suggests that multiple samples were tested for each parameter.
• Data Provenance: The testing was conducted by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, a Malaysian company. Therefore, the data originates from Malaysia. The study is retrospective in the sense that the data presented reflects tests already performed on the manufactured gloves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This type of device (patient examination gloves) does not typically involve "experts" establishing a subjective ground truth in the way medical imaging or diagnostic devices might.
• The "ground truth" for these tests is based on objective, standardized measurements performed according to ASTM standards and FDA requirements. The measurements are taken by laboratory personnel or quality control technicians. The document does not specify the number or qualifications of the individuals who performed these measurements, but it is implied they are qualified to conduct such tests according to established protocols.

4. Adjudication Method for the Test Set:

• Adjudication methods like "2+1" or "3+1" are not applicable here. This refers to consensus building among multiple human reviewers for subjective assessments.
• For objective laboratory tests of physical properties and chemical content, the results are quantitative measurements. The "adjudication" is inherent in the measurement protocol itself, with results being compared directly against the specified ASTM and FDA thresholds. If a measurement falls within the acceptable range, it passes; otherwise, it fails.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of medical imaging or diagnostic AI on human reader performance, which is not relevant for physical medical devices like examination gloves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone "algorithm only" study was not done. This device is a physical product, not an AI algorithm. The performance is assessed directly through physical and chemical testing, not through an algorithm's output.

7. Type of Ground Truth Used:

• The ground truth used for this study is based on objective, measurable criteria defined by:
  • ASTM standard D 3578-99 for Latex Examination Gloves.
  • FDA pinhole requirements.
  • Company's own labeling claim for protein content (50 micrograms or less).
  • FDA biocompatibility requirements (implied by "Passed*" for Skin Irritation and Dermal Sensitization tests, which likely refer to ISO 10993 or similar standards).

8. Sample Size for the Training Set:

• This concept is not applicable here. "Training set" refers to data used to train a machine learning algorithm. This device is a manufactured physical product, not an AI or software device that undergoes a training process.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable as there is no training set for a physical examination glove.

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