Search Results
Found 1 results
510(k) Data Aggregation
(119 days)
The Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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 and Fentanyl Citrate as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 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 (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml)
Warning: Not for Use With: Carmustine, ThioTEPA
Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: Halyard Lavender Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Regulatory Class: Class I (Non-Powdered Patient Examination Glove, Specialty; Fentanyl and other opioid protection glove)
Study Design Overview:
This appears to be a non-clinical performance study focusing on the physical characteristics and chemical permeation resistance of the gloves. It is a comparative study against a previously cleared predicate device (Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs). The primary method used for evaluating chemical permeation was ASTM D6978-05.
1. Table of Acceptance Criteria & Reported Device Performance
| Test/Characteristic | Standard | Acceptance Criteria | Reported Device Performance and Remarks |
|---|---|---|---|
| Chemical Permeation | ASTM D6978-05 | No breakthrough detected for up to 240 minutes for listed drugs. | Chemotherapy Drugs (NO Breakthrough up to 240 minutes): Azacitidine (25 mg/ml), Bendamustine HCl (5 mg/ml), Bleomycin Sulfate (15 mg/ml), Bortezomib (1 mg/ml), Busulfan (6 mg/ml), Capecitabine (26 mg/ml), Carboplatin (10 mg/ml), Carlzomib (2 mg/ml), Cetuximab (2 mg/ml), Chloroquine (50 mg/ml), Cisplatin (1 mg/ml), Cladribine (1 mg/ml), Cyclophosphamide (20 mg/ml), Cyclosporin A (100 mg/ml), Cytarabine (Cytosine) (100 mg/ml), Cytovene (Ganciclovir) (10 mg/ml), Dacarbazine (DTIC) (10 mg/ml), Dactinomycin (0.5 mg/ml), Daunorubicin HCl (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCl (2 mg/ml), Epirubicin HCl (Ellence) (2 mg/ml), Etoposide (Toposar) (20 mg/ml), Fludarabine (25 mg/ml), 5-Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan HCl (20 mg/ml), Leuprolide Acetate Salt (5 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 (5 mg/ml), Paclitaxel (6 mg/ml), Pemetrexed (25 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Topotecan HCl (1 mg/ml), Triclosan (2 mg/ml), Trisenox (1 mg/ml), Vinblastine Sulfate (1 mg/ml), Vincristine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml)Chemotherapy Drugs (Breakthrough < 60 minutes, with specific breakthrough times): Carmustine (3.3 mg/ml) - No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) - No breakthrough up to 30.9 minutes.Hazardous Drugs (Opioids) (NO Breakthrough up to 240 minutes): Fentanyl Citrate Injection (100 mcg/2 ml)Warning: Not for Use With: Carmustine, ThioTEPA. The device meets the acceptance criteria for those drugs where no breakthrough was detected for up to 240 minutes and explicitly warns for those with early breakthrough. |
| Dimensions | ASTM D6319 | Length: 295 – 325 mmPalm Width (Sizes XS-XL): 60 – 130 mm (range)Finger thickness: 0.10-0.19 mmPalm thickness: 0.10-0.16 mmCuff thickness: 0.10-0.13 mm | Meets requirements. (Specific values not provided in this summary, but stated as meeting standard). |
| Physical Properties | ASTM D6319 | AQL 4.0Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements. The physical properties met the requirements for tensile strength and elongation before and after aging. |
| Freedom from Pinholes | ASTM D6319, ASTM D5151 | AQL 2.5%, No leakage | Meets requirements. Testing showed it meets the 2.5% AQL requirement in the standards for leakage. |
| Powder Free | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove | Meets requirements. Residual powder was an average of 0.4 mg/glove, which is within the powder-free limit. |
| Biocompatibility (Irritation) | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Meets acceptance criteria. Under the conditions of the study, the device is not an irritant. |
| Biocompatibility (Systemic Toxicity) | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | Meets acceptance criteria. No evidence of systemic toxicity under the conditions of the study. |
| Biocompatibility (Dermal Sensitization) | ISO 10993, Part 10 | Grade < 1 | Meets acceptance criteria. Under the conditions of the study, the device is not a sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific sample sizes (number of gloves or individual tests) for each test. However, it references conformity to various ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151-06, ASTM D6319-10, ISO 10993 parts 10 and 11), which implicitly define the required sample sizes for such tests.
- Data Provenance: The data appears to be from non-clinical, prospective laboratory testing conducted by the manufacturer (O & M Halyard, Inc.) to demonstrate compliance with recognized industry standards for medical gloves. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer's location (Alpharetta, Georgia, USA), and the testing would adhere to international standards (ASTM, ISO).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This detailed information is not provided in the 510(k) summary. For non-clinical performance and biocompatibility studies of this type (testing against standard specifications), "experts" in the traditional sense of clinical adjudication are not typically involved. The "ground truth" is established by the standardized test methods themselves and the specified acceptance criteria. The lab personnel conducting the tests would be qualified per the relevant test standards (e.g., trained technicians, chemists, biologists).
4. Adjudication Method for the Test Set:
- None in the sense of clinical image review or multi-reader evaluation. The ground truth is determined directly by the quantitative and qualitative results of the standardized physical, chemical, and biological tests as per the ASTM and ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This device is a medical glove, and its performance evaluation relates to physical, chemical, and biological properties, not diagnostic or interpretive clinical effectiveness by human readers. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a "standalone" performance evaluation was done in the sense that the glove's resistance to chemical permeation and its physical/biological properties were tested directly, independent of human interaction during clinical use for the purpose of the test. The "algorithm" here is the glove itself and its material properties, tested in a laboratory setting.
7. The Type of Ground Truth Used:
- The ground truth is based on objective, standardized laboratory test results as defined by:
- Consensus Standards: ASTM D6978-05 (chemical permeation), ASTM D5151-06 (pinholes), ASTM D6319-10 (physical properties, dimensions, powder), and ISO 10993 parts 10 and 11 (biocompatibility).
- Predefined Acceptance Criteria specified in these standards (e.g., breakthrough time, AQL levels, mechanical property thresholds, irritation indices).
8. The Sample Size for the Training Set:
- Not applicable. This submission is for a physical medical device (gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "development" of the glove material and design would have involved iterative testing and refinement, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (as explained in point 8).
Ask a specific question about this device
Page 1 of 1