(167 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document describes the premarket notification (510(k)) for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K193555). The core of the submission, as it relates to proving the device meets acceptance criteria, focuses on the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.
Here's an analysis of the provided information to answer your questions:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria for the chemotherapy drug and fentanyl citrate resistance are the "Minimum Breakthrough Detection Time (Min.)" as per ASTM D6978-05. The device aims to achieve a breakthrough time of "> 240 minutes" for most listed drugs.
| Test Chemotherapy Drug / Fentanyl Citrate | Concentration (mg/ml or mcg/2mL) | Acceptance Criteria (Minimum Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time - Short Cuff) | Reported Device Performance (Breakthrough Detection Time - Long Cuff) |
|---|---|---|---|---|
| Arsenic Trioxide | 1.0 | > 240 min | > 240 min | N/A |
| Azacitidine (Vidaza) | 25.0 | > 240 min | > 240 min | N/A |
| Bendamustine HCl | 5.0 | > 240 min | > 240 min | N/A |
| Bleomycin Sulfate | 15.0 | > 240 min | > 240 min | N/A |
| Bortezomib (Velcade) | 1.0 | > 240 min | > 240 min | N/A |
| Busulfan | 6.0 | > 240 min | > 240 min | N/A |
| Carboplatin | 10.0 | > 240 min | > 240 min | N/A |
| Carfilzomib | 2.0 | > 240 min | > 240 min | N/A |
| Carmustine (BCNU) | 3.3 | Not specified for new device directly, but predicate showed 6.2 min. New device aims to show improved or similar performance. | 21.5 min | 37.5 min |
| Cetuximab (Erbitux) | 2.0 | > 240 min | > 240 min | N/A |
| Chloroquine | 50.0 | > 240 min | > 240 min | N/A |
| Cisplatin | 1.0 | > 240 min | > 240 min | N/A |
| Cladribine | 1.0 | > 240 min | > 240 min | N/A |
| Cyclophosphamide | 20.0 | > 240 min | > 240 min | N/A |
| Cyclosporine A | 100.0 | > 240 min | > 240 min | N/A |
| Cytarabine | 100.0 | > 240 min | > 240 min | N/A |
| Cytovene (Ganciclovir) | 10.0 | > 240 min | > 240 min (Found in Indications for Use table, not explicitly in the detailed comparison table) | N/A |
| Dacarbazine | 10.0 | > 240 min | > 240 min | N/A |
| Daunorubicin | 5.0 | > 240 min | > 240 min | N/A |
| Decitabine | 5.0 | > 240 min | > 240 min | N/A |
| Docetaxel | 10.0 | > 240 min | > 240 min | N/A |
| Doxorubicin Hydrochloride | 2.0 | > 240 min | > 240 min | N/A |
| Epirubicin (Ellence) | 2.0 | > 240 min | > 240 min | N/A |
| Etoposide | 20.0 | > 240 min | > 240 min | N/A |
| Fludarabine | 25.0 | > 240 min | > 240 min | N/A |
| Fluorouracil | 50.0 | > 240 min | > 240 min | N/A |
| Fulvestrant | 50.0 | > 240 min | > 240 min | N/A |
| Gemcitabine | 38.0 | > 240 min | > 240 min | N/A |
| Idarubicin | 1.0 | > 240 min | > 240 min | N/A |
| Ifosfamide | 50.0 | > 240 min | > 240 min | N/A |
| Irinotecan | 20.0 | > 240 min | > 240 min | N/A |
| Mechlorethamine HCl | 1.0 | > 240 min | > 240 min | N/A |
| Melphalan | 5.0 | > 240 min | > 240 min | N/A |
| Methotrexate | 25.0 | > 240 min | > 240 min | N/A |
| Mesna | 100.0 | > 240 min | > 240 min | N/A |
| Mitomycin C | 0.5 | > 240 min | > 240 min | N/A |
| Mitoxantrone | 2.0 | > 240 min | > 240 min | N/A |
| Oxaliplatin | 5.0 | > 240 min | > 240 min | N/A |
| Paclitaxel | 6.0 | > 240 min | > 240 min | N/A |
| Paraplatin | 10.0 | > 240 min | > 240 min | N/A |
| Pemetrexed | 25.0 | > 240 min | > 240 min | N/A |
| Pertuzumab | 30.0 | > 240 min | > 240 min | N/A |
| Raltitrexed | 0.5 | > 240 min | > 240 min | N/A |
| Retrovir | 10.0 | > 240 min | > 240 min | N/A |
| Rituximab | 10.0 | > 240 min | > 240 min | N/A |
| Temsirolimus | 25.0 | > 240 min | > 240 min | N/A |
| Thiotepa | 10.0 | Not specified for new device directly, but predicate showed 38.8 min. New device aims to show improved or similar performance. | 23.1 min | 13.6 min |
| Topotecan HCl | 1.0 | > 240 min | > 240 min | N/A |
| Trastuzumab | 21.0 | > 240 min | > 240 min | N/A |
| Triclosan | 2.0 | > 240 min | > 240 min | N/A |
| Trisenox | 1.0 | > 240 min | > 240 min | N/A |
| Vinblastine | 1.0 | > 240 min | > 240 min | N/A |
| Vincristine Sulfate | 1.0 | > 240 min | > 240 min | N/A |
| Vinorelbine | 10.0 | > 240 min | > 240 min | N/A |
| Zoledronic Acid | 0.8 | > 240 min | > 240 min | N/A |
| Fentanyl Citrate Injection | 100 mcg/2mL | > 240 min | > 240 min | N/A |
Note on Acceptance Criteria: For most drugs, the stated acceptance criterion is explicitly given as "> 240 minutes" in the "Indications for Use" section and confirmed by the reported performance. For Carmustine and Thiotepa, the document highlights their "extremely low permeation time" and provides their specific breakthrough times. The comparison table (Table 2) then compares these to the predicate, showing the new device's performance. The "Warning: do not use with Carmustine and Thiotepa" statement effectively sets the acceptance criteria for these specific drugs as less than the ideal >240 minutes, acknowledging their known rapid permeation through gloves. The aim for these is to show performance comparable or better than the predicate, which the subject device achieves for Carmustine, but is slightly worse for Thiotepa (Thiotepa: predicate 38.8 min, subject device 23.1 min (short cuff) and 13.6 min (long cuff)). However, since a warning is issued, this outcome appears to be accepted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves/samples tested for each drug permeation. It refers to testing "in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs," which would define the sample size requirements for the test. However, the exact sample numbers (e.g., how many gloves were tested for each drug) are not provided in this summary.
- Data Provenance: The tests were conducted by Ever Global (Vietnam) Enterprise Corp (Vietnam). The type of study for these tests would be prospective bench testing, as new gloves were manufactured and then tested for their characteristics.
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 is a device performance study based on laboratory bench testing, not an AI or diagnostic study involving expert interpretation of medical images. Therefore:
- Number of experts: Not applicable. Ground truth for material properties (like drug permeation) is established through standardized laboratory procedures and measurements.
- Qualifications of experts: Not applicable in the context of human expert review of "ground truth" for clinical data. The "experts" here would be the laboratory personnel qualified to perform ASTM D6978-05 and other relevant material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader interpretation or adjudication. Device performance is determined by direct physical and chemical testing according to established ASTM standards.
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 510(k) submission for a physical medical device (gloves), 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 is a physical device, not an algorithm. The "standalone performance" is the intrinsic material property of the glove against chemical permeation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance regarding chemotherapy drug and fentanyl permeation is established through direct laboratory measurement using the methodology outlined in ASTM D6978-05. This standard defines how resistance to permeation is assessed, with breakthrough time being the key metric. For other properties like tensile strength, freedom from holes, powder residual, and biocompatibility, the ground truth is also established by specific ASTM standards and biological evaluation guidelines (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. This is a traditional device submission, not an AI/machine learning product that requires a "training set." The gloves are manufactured, and then samples from the manufacturing batches are subjected to testing (the "test set" in this context).
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.