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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes

Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving a device meets acceptance criteria related to a medical imaging AI device or similar complex medical technology.

The text exclusively details the clearance of Latex Examination Gloves Powder Free (Ocean Blue and Natural White), citing regulation numbers, product codes, and the review process for market clearance. It mentions general controls, quality system regulations, UDI rules, and reporting of adverse events, all pertaining to the manufacturing and marketing of physical medical devices (gloves in this case), not performance studies of an AI algorithm or diagnostic device.

Therefore, I cannot extract the information required to answer your specific questions about acceptance criteria, study design, ground truth, or expert involvement, as this information is not present in the provided document.

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A patient 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.

The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.

They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.

The provided document is a 510(k) Premarket Notification for a Latex Examination Glove. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not describe an AI/ML-driven medical device. Therefore, it does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets acceptance criteria.

The questions posed relate to the development and validation of an AI/ML device, which typically involves data sets, expert labeling, ground truth establishment, and performance metrics like sensitivity, specificity, or AUC. The provided text, however, focuses on:

• Physical properties of rubber gloves: Dimensions, tensile strength, elongation, freedom from holes, residual powder, and protein content.
• Biocompatibility testing: Skin irritation, dermal sensitization, and acute systemic toxicity.
• Comparison to a predicate device: Highlighting similarities in intended use, materials, and compliance with standards.

Since the document is for a physical medical product (gloves) and not an AI/ML device, I cannot extract the information required to answer your specific questions.

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A patient 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 the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

1. 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 for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.

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 an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

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 an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
• 21 CFR 800.20 (dealing with devices that prevent contamination)
• ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

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A patient 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.

LATEX EXAMINATION GLOVE POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).

This document is solely an approval letter for a medical device that falls under general controls.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and the examiner.

Gentle Skin and (multiple labels) Powder Free, Polyment Coated Glove (With Protein Label Claim)/ 50 ml

This document is a 510(k) clearance letter from the FDA for a medical device: "Gentle Skin and (Multiple Labels) Powder Free, Polymer Coated Glove (With Protein Label Claim) (50 Micrograms or Less)". It declares substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving device performance in the way typically expected for an AI/CAD device. This document is a regulatory clearance for a medical glove, not for a software or AI-based diagnostic tool.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study given the input. The questions in the prompt (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set size) are relevant for AI/CAD devices but not for a physical product like a medical glove, especially based on the information provided in this 510(k) summary.

The only "performance" claim mentioned is "50 Micrograms or Less" related to protein content. This implies a chemical or material property, not diagnostic accuracy.

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The provided document is a 510(k) premarket notification letter from the FDA regarding "Brightway Brand Latex Examination Gloves." This letter does not contain any information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to medical device software or AI/ML-based devices.

The document is an approval for a physical medical device (gloves) and outlines regulatory compliance for registration, labeling, and manufacturing practices, not performance metrics for an AI system.

Therefore, I cannot provide the requested information based on the input text.

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A patient 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.

POWDER-FREE LATEX EXAM GLOVES, WITH PROTEIN LABELING (50 ug/g or less)

This document is a 510(k) Pre-market Notification for Powder-Free Latex Exam Gloves. The information provided outlines the device's characteristics and its substantial equivalence to previously approved devices. However, it does not contain the type of detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or complex diagnostics. Instead, it focuses on compliance with established standards for medical gloves.

Given this context, I will interpret "acceptance criteria" as the performance standards outlined for medical gloves and "study" as the testing reported in the 510(k) summary. Many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, training set, etc.) are not applicable to this type of device and submission.

Here's the information extracted and interpreted based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this device type)

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

   • Sample Size: Not specified in the provided document. The standards listed (e.g., ASTM D 5712-95, ISO 2859) define specific sampling plans and test methods, but the number of units tested is not reported here.
   • Data Provenance: The device is manufactured by HYCARE INTERNATIONAL CO., LTD. in Hat-Yai, Songkhla, Thailand. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but typically for this type of product, it would be prospective testing of manufactured samples.

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

   • Not Applicable. For medical gloves, "ground truth" as a concept for expert assessment (e.g., of images or diagnoses) is not relevant. Performance is determined by objective physical and chemical testing against established standards.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of complex data (e.g., medical images). For medical gloves, adherence to standards is determined by direct measurement and observation during testing, not by expert consensus or adjudication.

4. 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 a medical device (latex examination gloves), not an AI/ML diagnostic tool or an imaging system. MRMC studies are not relevant to its evaluation.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • For this device, "ground truth" is defined by the objective specifications and quantifiable limits set by international and national standards (e.g., ASTM D 5712-95 for tensile strength, elongation, etc.; ASTM D 6124-97 for extractable protein levels; ISO 2859 for sampling procedures and acceptance quality limits). Biocompatibility is assessed based on in vitro and in vivo (animal, not human) tests with established criteria for response.

7. The sample size for the training set:

   • Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

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

   • Not Applicable. As there is no training set, this question is not relevant.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim

The provided document is an FDA 510(k) premarket notification letter for a medical device: "Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices and allows it to be marketed.

However, the document does not contain any information regarding the acceptance criteria, device performance, or any studies that prove the device meets specific performance criteria. The FDA letter itself states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements and statutes and regulations administered by other Federal agencies." It primarily focuses on the regulatory clearance process based on substantial equivalence to existing devices, not on a detailed analysis of performance studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter, not a technical report detailing performance studies.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)."

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's functional performance metrics.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.

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A patient 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.

Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)

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