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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

• Arsenic Trioxide (0.1mg/ml),(100ppm) >240 Minutes
• Bleomycin Sulfate (15mg/ml),(15,000 ppm) >240 Minutes
• Busulfan(6mg/ml),(6,000 ppm) >240 Minutes
• Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 127.5 Minutes
• Cisplatin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes
• Cytarabine(100mg/ml), (100,000 ppm) >240 Minutes
• Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) >240 Minutes
• Daunorubicin(5mg/ml), (5,000 ppm) >240 Minutes
• Docetaxel(10mg/ml), (10,000 ppm) >240 Minutes
• Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes
• Ellence (2mg/ml), (2,000 ppm) >240 Minutes
• Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes
• Fludarabine (25mg/ml), (25,000 ppm) >240 Minutes
• Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes
• Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) >240 Minutes
• Idarubicin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes
• Irinotecan(20mg/ml), (20,000 ppm) >240 Minutes
• Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) >240 Minutes
• Melphalan(5mg/ml), (5,000 ppm) >240 Minutes
• Methotrexate(25mg/ml),(25,000 ppm) >240 Minutes
• Mitomycin C(0.5 mg/ml), (500 ppm) >240 Minutes
• Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes
• Paclitaxel(6.0mg/ml),(6,000 ppm) >240 Minutes
• Paraplatin (10mg/ml),(10,000 ppm) >240 Minutes
• Rituximab(10mg/ml),(10,000 ppm) >240 Minutes
• Thiotepa (10mg/ml),(10,000 ppm) >240 Minutes
• Trisenox(0.1mg/ml), (100 ppm) >240 Minutes
• Vincristine Sulfate(1.0mg/ml).(1.000 ppm) >240 Minutes

Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.

The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Purple in color, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

This document describes the premarket notification (510(k)) for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS, seeking to prove substantial equivalence to a predicate device. The "acceptance criteria" here refers to the performance standards and regulatory requirements that the device must meet to be considered substantially equivalent to a legally marketed predicate device, rather than specific AI/ML performance metrics. Similarly, the "study" proving the device meets these criteria refers to the non-clinical testing performed on the gloves.

Given the nature of the device (examination gloves), the concepts of "AI assistance," "human observers," "training set," and "ground truth" (in the context of expert consensus or pathology for medical images/diagnoses) are not applicable. The "study" here is a series of non-clinical, laboratory-based tests to demonstrate the physical properties, biocompatibility, and chemical permeation resistance of the gloves.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized industry standards (ASTM, ISO) and FDA regulations. The reported device performance is the outcome of testing against these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Information (Non-Clinical Testing for Gloves)

Since this is a filing for medical examination gloves, the concepts below regarding AI/ML studies are not directly applicable. However, I will interpret them in the context of the testing performed on these physical devices.

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

   • Sample Size: The document does not explicitly state the number of gloves tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many samples for tensile strength). The standards referenced (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ASTM D6978-05) would specify the required sample sizes for each test.
   • Data Provenance: The testing was performed according to international harmonized standards (ASTM, ISO). The manufacturer is Brightway Holdings Sdn Bhd. from Malaysia (Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, 42100 MY). The data is implicitly prospective, as it was generated specifically for this 510(k) submission.

2. 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 in the AI/ML context. For physical device testing, the "ground truth" is established by the test methods themselves, defined by standards organizations (ASTM, ISO). The "experts" would be the certified laboratory technicians and engineers who perform the tests according to the standard operating procedures and interpret the results against the specified criteria. Their qualifications would be in laboratory science, materials testing, and adherence to quality systems.

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

   • Not applicable in the AI/ML context. For physical device testing, results are typically quantitative measurements or pass/fail determinations based on predefined criteria in the standards. Discrepancies would be resolved through re-testing or investigation into the test methodology, not through human consensus or adjudication of interpretations.

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 physical medical device (examination glove), not an AI/ML diagnostic or assistive tool.

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

   • Not applicable.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • The "ground truth" is based on standardized test methods and predefined quantitative/qualitative thresholds set by organizations like ASTM and ISO. For example, for "Freedom from Pinholes," the ground truth is a "Pass" or "Fail" based on a specified water leak test (FDA 1000ml water leak test) as incorporated into ASTM 6319-10. For chemotherapy permeation, the ground truth is the "breakthrough detection time" measured in minutes. Biocompatibility tests rely on established in-vitro and in-vivo assays with pass/fail criteria for irritation, sensitization, and toxicity.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is consistent, and quality control ensures consistency, but there isn't a "training set" in the AI sense.

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

   • Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is a Lavender Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Lavender in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

Here's a breakdown of the acceptance criteria and study information for the Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender), based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2.
   • Water-tight Test: 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.5, Ac=7 Rej=8.
   • Physical Properties Analysis: Not explicitly stated but "Single Normal S2 AQL: 2.5 Acc/Rej : 1/2" for sampling plan. Given that 20 samples were tested and individual results are shown, it seems 20 samples were used for the physical properties test.
   • Biocompatibility Studies (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Sample sizes for these tests are not provided in the document.
   • Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd (the manufacturer) in Malaysia. The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, it would typically involve prospective testing of newly manufactured devices.

2. 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 to the device described. The "ground truth" for examination gloves is established by standardized physical and chemical testing methods (ASTM, ISO), not by expert consensus or interpretations.

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

   • Not applicable. Performance is measured against objective standards, not subjective interpretations requiring 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 device is an examination glove, not an AI-powered diagnostic or assistive tool.

5. 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.

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

   • The "ground truth" for this device is based on objective, standardized measurements and tests outlined in recognized standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D5151 (Water Leak Test), ASTM D6124 (Residual Powder), and ISO 10993 (Biocompatibility).

7. The sample size for the training set:

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

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

   • Not applicable. This device is not an AI/machine learning model.

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