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The Halyard Pink Underguard Nittile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:

· Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
· Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
· Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
· Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
· Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
· Busulfan (6 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
· Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
· Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
· Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
· Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
Cytovene (10 mg/ml) No breakthrough up to 240 minutes
· Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
· Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
Decitabine (5 mg/ml) No breakthrough up to 240 minutes
Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
· Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
· Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
Etoposide (20 mg/ml) No breakthrough up to 240 minutes
Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
· Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
· Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
· Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
· Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
Melphalan (5 mg/ml) No breakthrough up to 240 minutes
· Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
· Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
· Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
· Retrovir (10 mg/ml) No breakthrough up to 240 minutes
· Rituximab (10 mg/ml) No breakthrough up to 240 minutes
· Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
· Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
· Triclosan (2 mg/ml) No breakthrough up to 240 minutes
Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
· Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
· Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
· Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes

CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:

Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
· ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes

Device Description

Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non- sterile patient examination gloves that are packed in a cardboard dispenser box.

AI/ML Overview

The device described is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Characteristic / Test Method	Acceptance Criteria (from standard)	Reported Device Performance
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs	No signs of breakthrough after 4 hours for 50 drugs, except for Carmustine and ThioTEPA.	Meets Acceptance Criteria: - No breakthrough up to 240 minutes for 50 chemotherapy drugs: Arsenic Trioxide (1 mg/ml), Azacitidine (Vidaza) (25 mg/ml), Bendamustine (5 mg/ml), Bortezomib (Velcade) (1 mg/ml), Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Carfilzomib (2 mg/ml), Cetuximab (Erbitux) (2 mg/ml), Cisplatin (1 mg/ml), Cladribine (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCL (100 mg/ml), Cytovene (10 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCL (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCL (2 mg/ml), Ellence (2 mg/ml), Etoposide (20 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan (20 mg/ml), Mechlorethamine HCL (1 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin (0.5 mg/ml), Mitoxantrone (2 mg/ml), Oxaliplatin (2 mg/ml), Paclitaxel (6 mg/ml), Paraplatin (10 mg/ml), Pemetrexed (25 mg/ml), Pertuzumab (30 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Trastuzumab (21 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1.0 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml). - Limited breakthrough times for specific drugs: Carmustine (3.3 mg/ml): No breakthrough up to 54.7 minutes ThioTEPA (10 mg/ml): No breakthrough up to 128.5 minutes
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	2.5% AQL (Acceptable Quality Limit) for leakage.	Meets the 2.5% AQL requirement for leakage.
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications	Within limits for physical dimensions; meet requirements for tensile strength and elongation. (Specific numerical criteria for tensile strength and elongation are implied by the standard but not fully detailed in the provided text for acceptance, only for performance. For the predicate, 38 MPa tensile strength after aging and 550% elongation after aging are mentioned as targets).	Physical dimensions are within the limits of the standard. Physical Properties: - Tensile Strength: Average 37.89 MPa before aging, 39.32 MPa after aging. - Elongation: 602% before aging, 558% after aging.
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves	Powder-free limit of < 2 mg maximum powder per glove.	Average of 0.4 mg/glove, meeting the powder-free limit.
ISO 10993-11: 2017 Tests for Systemic Toxicity (Systemic Injection Test in Mice)	No mortality or evidence of systemic toxicity.	No mortality or evidence of systemic toxicity from the extracts (NaCl and Cottonseed Oil).
ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization (Dermal Irritation Test in Rabbits)	Extracts considered non-irritating.	Test article extracts were considered non-irritating.
ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization (Dermal Sensitization Test)	No evidence of causing delayed dermal contact sensitization.	Test article extracts showed no evidence of causing delayed dermal contact sensitization.

Detailed Study Information:

The provided document is a 510(k) Premarket Notification summary from the FDA, evaluating the subject device against a predicate device. The "studies" are in fact non-clinical performance tests conducted against recognized international standards and ASTM methods.

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

ASTM D6978-05 (Chemotherapy Drug Permeation): The document does not specify the exact sample size (number of gloves or replicates for each drug) used for the permeation testing for the subject device. The predicate device tested 12 drugs, while the subject device tested 52 drugs. The data provenance is not explicitly stated as country of origin, but it is implied to be laboratory testing for regulatory submission in the US (FDA). The nature of these tests is prospective for the purpose of the submission.
ASTM D5151-06 (Holes in Medical Gloves): The document does not specify the exact sample size. It states that testing "meets the 2.5% AQL requirement," which implies a sampling plan was used according to the standard, but the specific number of gloves tested is not provided. Data provenance is implied as laboratory testing.
ASTM D6319-10 (Physical Properties): The document mentions average tensile strength and elongation values before and after aging. The sample size for these measurements (number of gloves or test specimens) is not specified. Data provenance is implied as laboratory testing.
ASTM D6124-06 (Residual Powder): The document notes an "average of 0.4 mg/glove." The sample size for this average is not provided. Data provenance is implied as laboratory testing.
ISO 10993-11 (Systemic Toxicity): The test specifies "ISO Systemic Injection Test in Mice." The number of mice used is not provided. Data provenance is implied as laboratory testing.
ISO 10993-10 (Dermal Irritation): The test specifies "ISO Indirect Primary Skin Irritation Test in Rabbits." The number of rabbits used is not provided. Data provenance is implied as laboratory testing.
ISO 10993-10 (Dermal Sensitization): The test specifies "ISO Kligman Maximization Test." The number of animals used is not provided. Data provenance is implied as laboratory testing.

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

This type of submission (510(k) for a medical glove) does not involve human expert interpretation of data in the way a diagnostic AI would. The "ground truth" for these tests are the objective measurements from laboratory instruments and observations by trained technicians following standardized protocols (e.g., timing of breakthrough, physical property measurements, biological responses in animal models). Therefore, there were no "experts" establishing ground truth in the context of radiologists or similar clinical experts.

4. Adjudication method for the test set

Not applicable. As described in point 3, these are objective laboratory tests against established standards. There is no subjective interpretation or adjudication process required between multiple human readers or experts for the test results.

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 a submission for a non-diagnostic physical medical device (exam glove) and does not involve AI, human readers, or medical imaging, so an MRMC study is irrelevant here.

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

Not applicable. There is no algorithm or AI component to this medical device.

7. The type of ground truth used

The "ground truth" in this context refers to the directly measured and objectively determined results from standardized laboratory tests. These include:

Direct measurement of permeation time: For chemotherapy drugs (ASTM D6978-05).
Observed absence/presence of leakage: For holes (ASTM D5151-06).
Direct physical measurements: Tensile strength, elongation, glove dimensions (ASTM D6319-10).
Direct chemical measurement: Residual powder weight (ASTM D6124-06).
In-vivo biological observations: Mortality, signs of systemic toxicity, irritation, dermal sensitization in animal models (ISO 10993-11, ISO 10993-10).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set." The product undergoes manufacturing processes, and quality control tests (which might involve some internal data collection over time) ensure consistency, but this is distinct from training an algorithm.

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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