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510(k) Data Aggregation
(91 days)
The Halyard Purple Nitrile Max Powder-Free Nitrile 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
Carlzomib (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
ThioTEPA (10 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 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
Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes
Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (K182096).
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for this specific type of medical glove. It is crucial to understand that this is a physical medical device, not software or AI, so the typical AI-related terms like "training set," "test set," "human-in-the-loop," "MRMC," "adjudication," and "expert qualifications" are not applicable in this context. The "studies" here refer to laboratory testing of physical properties.
Here's the breakdown of the acceptance criteria and the proof it meets them, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Standard / Characteristic | Acceptance Criteria | Reported Device Performance (Subject Device K182096) |
|---|---|---|
| ASTM D6978-05 (Permeation by Chemotherapy Drugs) | - No breakthrough up to 240 minutes for listed chemotherapy drugs.- For Carmustine, the acceptance criterion is that permeation occurs at a time greater than the predicate device. | - No signs of breakthrough after 4 hours (240 minutes) for 51 drugs.- Carmustine showed no signs of breakthrough until 128.5 minutes (which is longer than the predicate's 80.4 minutes).- Result: Meets acceptance criteria.Specific Drugs tested showing No Breakthrough up to 240 minutes: 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 (1.0 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), Epirubicin (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-C (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), ThioTEPA (10 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml). |
| ASTM D5151-06 (Detection of Holes in Medical Gloves) | Meets the 2.5% AQL (Acceptable Quality Level) requirement for leakage. | Testing shows it meets the 2.5% AQL requirement. The device meets the acceptance criteria. |
| ASTM D6124-06 (Residual Powder on Medical Gloves) | Powder-free limit of < 2 mg maximum powder per glove. | Residual powder is an average of 0.4 mg/glove, which is within the powder-free limit. The device meets the acceptance criteria for powder-free. |
| ASTM D6319-10 (Nitrile Examination Gloves for Medical Applications) | Physical dimensions are within limits of the standard, and physical properties (tensile strength and elongation) meet requirements. | Physical dimensions are within the limits of the standard. Tensile strength: average before aging 36.80 MPa, after aging 41.06 MPa. Elongation: 748% before aging, 627% after aging. (These values are implicitly shown to meet the standard's requirements, as "The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength... and elongation.") |
| ISO 10993-11 (Tests for Systemic Toxicity) | No signs of systemic toxicity up to 72 hours post injection. | No systemic toxicity observed. Result: Meets acceptance criteria. |
| ISO 10993-10 (Tests for Irritation and Skin Sensitization) | Sensitization: Grades of less than 1 observed in the test group, and positive control performed as anticipated.Irritation: Grades of less than 1 observed. | Sensitization: Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig (Grade 0). Result: Meets acceptance criteria.Irritation: Based on the criteria of the protocol, the glove was considered non-irritating. Result: Meets acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of gloves tested) for each specific test. It only refers to compliance with standards like ASTM D5151-06 (2.5% AQL), which implies a statistically appropriate sample size was used as defined by that standard.
- Data Provenance: The studies were laboratory tests conducted by the manufacturer (Owens & Minor Halyard, Inc., Alpharetta, Georgia, USA) to demonstrate compliance with international standards (ASTM, ISO). The data is prospective in the sense that it was generated specifically for this regulatory submission. It is not patient data or retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device and study. The "ground truth" for physical device performance (e.g., permeation, hole detection, tensile strength) is not established by human experts in the way it is for AI models interpreting medical images. Instead, it is established by adherence to validated and standardized laboratory test methods (e.g., ASTM, ISO guidelines) and objective measurements. The expertise lies in the certified laboratories and personnel performing these standardized tests.
4. Adjudication Method for the Test Set
This question is not applicable. Since the "ground truth" is based on objective laboratory measurements and standardized protocols, there is no need for expert adjudication in the context of human interpretation of data.
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
This question is not applicable. An MRMC study is relevant for AI (software) devices where human readers interpret medical images or data. This document describes a physical medical device (gloves) and its laboratory performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Standalone" performance refers to an algorithm's performance without human intervention. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is based on objective measurements and adherence to recognized performance standards derived from laboratory testing methodologies. These standards define acceptable levels of performance for specific physical and chemical properties (e.g., maximum allowable permeation by chemotherapy drugs, acceptable hole rates, minimum tensile strength, non-toxicity).
8. The sample size for the training set
This question is not applicable. This is a physical device, not an AI model. There is no "training set."
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 device, there is no ground truth established for it in this context. The "ground truth" for the device's performance is established by the methods outlined in standards like ASTM and ISO.
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