(184 days)
The Halyard Sterling Nitrile Powder-Free Exam Gloves are disposable devices 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 Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml). No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes
The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves are disposable devices 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 Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes
Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves and Halyard STERLING* Nitrile Powder-Free Exam Gloves tested for Use with Chemotherapy Drugs are disposable, grey-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) summary for Halyard Sterling* Nitrile Powder-Free Exam Gloves and Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves. It details the safety and performance characteristics of these medical gloves, particularly their resistance to permeation by chemotherapy drugs.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves and Halyard Sterling* Nitrile Powder-Free Exam Gloves) performance was evaluated against several standards for medical gloves and their resistance to chemotherapy drugs.
| Standard | Acceptance Criteria | Reported Device Performance (Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves) | Reported Device Performance (Halyard Sterling* Nitrile Powder-Free Exam Gloves) |
|---|---|---|---|
| ASTM D6978-05: Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | For most drugs, "No breakthrough up to 240 minutes." For specific drugs, breakthrough times are expected. | - No breakthrough up to 240 minutes for: Arsenic Trioxide, Doxorubicin HCL, Paclitaxel, Azacitidine, Epirubicin, Paraplatin, Bendamustine, Eribulin Mesylate, Pemetrexed, Bortezomib, Etoposide, Pertuzumab, Bleomycin sulfate, Fludarabine, Raltitrexed, Busulfan, Fluorouracil, Retrovir, Carboplatin, Fulvestrant, Rituximab, Carfilzomib, Gemcitabine, Temsirolimus, Cetuximab, Idarubicin, Trastuzumab, Cisplatin, Ifosfamide, Topotecan HCL, Cyclophosphamide, Irinotecan, Triclosan, Cytarabine HCL, Mechlorethamine HCL, Trisonex, Cytovene, Melphalan, Vincrinstine Sulfate, Dacarbazine, Methotrexate, Vinblastine, Daunorubicin HCL, Mitomycin-C, Vinorelbine, Decitabine, Mitoxantrone, Zoledronic Acid, Docetaxel, Oxaliplatin. |
- Breakthrough detected at 23.9 minutes for ThioTEPA (10 mg/ml).
- Breakthrough detected at 14.8 minutes for Carmustine (3.3 mg/ml). | - No breakthrough up to 240 minutes for: Arsenic Trioxide, Doxorubicin HCL, Paclitaxel, Azacitidine, Epirubicin, Paraplatin, Bendamustine, Eribulin Mesylate, Pemetrexed, Bortezomib, Etoposide, Pertuzumab, Bleomycin sulfate, Fludarabine, Raltitrexed, Busulfan, Fluorouracil, Retrovir, Carboplatin, Fulvestrant, Rituximab, Carfilzomib, Gemcitabine, Temsirolimus, Cetuximab, Idarubicin, Trastuzumab, Cisplatin, Ifosfamide, Topotecan HCL, Cyclophosphamide, Irinotecan, Triclosan, Cytarabine HCL, Mechlorethamine HCL, Trisonex, Cytovene, Melphalan, Vincrinstine Sulfate, Dacarbazine, Methotrexate, Vinblastine, Daunorubicin HCL, Mitomycin-C, Vinorelbine, Decitabine, Mitoxantrone, Zoledronic Acid, Docetaxel, Oxaliplatin.
- Breakthrough detected at 37.1 minutes for ThioTEPA (10 mg/ml).
- Breakthrough detected at 22.9 minutes for Carmustine (3.3 mg/ml). |
| ASTM D5151-06: Detection of Holes in Medical Gloves | Must meet an AQL of 2.5% for leakage. | Pass: Meets the 2.5% AQL requirement for leakage. | Pass: Meets the 2.5% AQL requirement for leakage. |
| ASTM D6124-06: Residual Powder on Medical Gloves | Less than 2 mg maximum powder per glove. | Pass: Average of 0.03 mg/glove, within the powder-free limit. | Pass: Average of 0.03 mg/glove, within the powder-free limit. |
| ASTM D6319-10: Specification for Nitrile Examination Gloves for Medical Applications | Within the limits of the standard for tensile strength and elongation before and after aging. | Pass: Average Tensile Strength (before aging) = 35.2 MPa; Average Tensile Strength (after aging) = 44.1 MPa; Average Elongation (before aging) = 606%; Average Elongation (after aging) = 553%. | Pass: Average Tensile Strength (before aging) = 37.2 MPa; Average Tensile Strength (after aging) = 41.6 MPa; Average Elongation (before aging) = 606%; Average Elongation (after aging) = 567%. |
| ISO 10993: Systemic Toxicity Study in Mice | No animals treated with test extracted exhibited greater reaction than control animals. | Pass: No mortality or evidence of systemic toxicity from the extracts. | Pass: No mortality or evidence of systemic toxicity from the extracts. |
| ISO 10993: Dermal Irritation | Primary Irritation Index ≤ Grade 1. | Pass: Considered non-irritating. | Pass: Considered non-irritating. |
| ISO 10993: Dermal Sensitization | Stimulation Index ≤ 3. | Pass: Showed no evidence of causing delayed dermal contact sensitization. | Pass: Showed no evidence of causing delayed dermal contact sensitization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of gloves tested for each drug or physical property) for the test sets. It describes the tests conducted according to the "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs" (ASTM D6978-05), and other ASTM and ISO standards, which inherently include methodologies for sample selection.
The data provenance is not specified in terms of country of origin, nor whether it was retrospective or prospective. It refers to the testing conducted on the subject device, implying this testing occurred directly for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not applicable to the studies described. The "ground truth" here is established by the standardized test methods themselves, which are objective measurements of physical and chemical properties of the gloves (e.g., breakthrough time for chemotherapy drugs, presence of holes, powder content, tensile strength, biological reaction in animal models). These are not studies that require expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective, standardized measurements, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a medical exam glove, and its effectiveness is determined by its physical and chemical properties under specified test conditions, not by human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of these gloves is defined by:
- Standardized Test Methods: Adherence to established industry standards like ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for hole detection, ASTM D6124-06 for residual powder, ASTM D6319-10 for physical properties, and ISO 10993 for biological evaluation.
- Objective Measurements: Direct measurements of physical properties (e.g., breakthrough time, amount of powder, tensile strength, elongation) and biological responses (e.g., systemic toxicity, irritation, sensitization).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of evaluating medical gloves through physical and chemical performance testing. This is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device evaluation.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.