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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml ≥ 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes
Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes

Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Not recommended for use with these drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.

The provided document is a 510(k) Premarket Notification for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. It details the acceptance criteria and performance data for this medical device, which is a non-powdered patient examination glove.

Here's an analysis of the requested information based on the provided text:

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

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

The document does not explicitly state the overall sample sizes for all tests beyond what is indicated in specific test results (e.g., in ASTM D5151, the number of gloves tested per size is implied by the X/125 format, and in ASTM D412 AQL, 1/13 is mentioned). The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned. The tests are non-clinical, meaning they are laboratory-based, not patient-based.

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)

This device is a physical medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized ASTM and ISO standards for physical, chemical, and biocompatibility properties. There are no human experts involved in establishing a "ground truth" in the way one would for diagnostic imaging. The measurements are objective, per standard protocols.

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

Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed against predefined statistical and physical thresholds in standardized 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 device is a medical glove, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical glove, not an algorithm.

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

The "ground truth" for this device is based on scientific and engineering standards for material properties, dimensions, physical performance, and biocompatibility, as defined by ASTM International and ISO. Examples include:

• Physical Dimensions: Measured and compared against ranges specified in ASTM D6319.
• Watertightness: Assessed by the AQL (Acceptable Quality Level) specified in ASTM D5151.
• Biocompatibility: Determined by adherence to ISO 10993 standards for cytotoxicity, systemic toxicity, irritation, and sensitization.
• Chemotherapy Drug Permeation: Measured breakthrough times as per ASTM D6978-05.

8. The sample size for the training set

Not applicable. This device is a medical glove, not a machine learning model, so there is no "training set."

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

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

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The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

This document describes the performance of a medical device, specifically Procedure Masks with Ear Loops and Surgical Masks with Ties, submitted for FDA 510(k) clearance (K221134). The device is compared to a predicate device (K202899) to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on ASTM F2100-19 for medical face mask performance, and other relevant standards like ASTM F1862/F1862M-17 (Fluid Resistance), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 + AC:2019 Annex C (Differential Pressure), 16 CFR 1610 (Flammability), ISO 10993-5: 2009 (Cytotoxicity), and ISO 10993-10: 2010 (Irritation and Sensitization).

There are two tables provided in the document:

• Table 1: Comparison of Performance Testing for Proposed ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate Device
• Table 2: Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device

Table 1: ASTM Level 1 Masks (PM3001 & SM3001)

Table 2: ASTM Level 3 Masks (PM3003 & SM3003)

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

• Sample Size for Test Set: For each non-clinical performance test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the tests were conducted on 32 samples from 3 non-consecutive lots, totaling 96 samples for each test. For cytotoxicity, irritation, and sensitization, specific sample sizes are not explicitly stated, but the results indicate evaluation was performed.
• Data Provenance: The document does not specify the country of origin of the data. It indicates these are "non-clinical testing" results, which implies laboratory testing. It does not state whether the data is retrospective or prospective, but as it concerns performance of the newly manufactured device, it would inherently be prospective testing.

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

No information is provided regarding human experts or ground truth establishment in the context of the performance tests for the masks. The "ground truth" for these tests is the quantitative measurement against established ASTM/EN/CFR standards, which are objective and do not require expert human interpretation in the way medical image analysis might.

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and yield quantitative results against defined criteria, not subjective interpretations requiring adjudication.

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

No. The document explicitly states: "No clinical testing is included in this submission." This type of study would typically be done for AI/CAD devices, not for basic personal protective equipment like masks where performance is evaluated through standardized material tests.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Not applicable. This is a physical medical device (mask), not an algorithm or software.

7. Type of Ground Truth Used

The ground truth for the performance tests is based on pre-defined, internationally recognized standards and test methods (e.g., ASTM, EN, CFR, ISO). Each test has a specific methodology and acceptance criterion for properties like filtration efficiency, fluid resistance, breathability, and biological safety.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, 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 a physical device.

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