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510(k) Data Aggregation
(92 days)
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |
Do not use with Carmustine or ThioTEPA.
The Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves. The gloves are offered in sizes small, medium, large, extra large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
The provided text describes the acceptance criteria and performance of "Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)". This is a medical device, specifically examination gloves, and the studies performed are non-clinical, primarily physical and chemical resistance tests. There is no mention of a study involving AI, human readers, or medical image analysis.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (width & thickness) (To evaluate the physical dimension of the glove) | Width: 70mm min. | |
| Length: 220mm min. | ||
| Palm: 0.05mm min. | ||
| Finger: 0.05mm min. | Pass | |
| 76mm min width | ||
| 229mm min length | ||
| Palm: 0.07mm min. | ||
| Finger: 0.08mm min. | ||
| Physical properties (To evaluate tensile strength and ultimate elongation before and after aging) | Tensile Strength: | |
| Before Aging ≥ 14 MPa, min. | ||
| After Aging ≥ 14 MPa, min. | ||
| Elongation: | ||
| Before Aging 500%, min. | ||
| After Aging 400%, min. | Pass | |
| Tensile Strength: | ||
| Before Aging 15.08 MPa, min. | ||
| After Aging 14.87 MPa, min. | ||
| Elongation: | ||
| Before Aging 570%, min. | ||
| After Aging 529%, min. | ||
| Freedom from holes (To detect holes in the gloves) | No leakage at sampling level of G-1, AQL 2.5 | Pass |
| No leakage, 80 of 80 passed of each size | ||
| Residual Powder (To detect powder residue in the glove) | 240min | |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL): >240min | ||
| Dacarbazine (DTIC) (10.0 mg/mL): >240min | ||
| Doxorubicin HCL (Adriamycin) (2.0 mg/mL): >240min | ||
| Etoposide (Toposar) (20.0 mg/mL): >240min | ||
| Fluorouracil (Adrucil) (50.0 mg/mL): >240min | ||
| Paclitaxel (Taxol) (6.0 mg/mL): >240min | ||
| Methotrexate (25.0 mg/mL): >240min | ||
| Vincristine sulfate (1.0 mg/mL): >240min |
The document explicitly states "Do not use with Carmustine or ThioTEPA." which aligns with the observed breakthrough times being below the >240min threshold for these two drugs (Carmustine: 6.2min, ThioTEPA: 8.4min). |
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 Physical Tests (Freedom from holes): 80 of 80 gloves passed for each size. (Specific sample sizes for other physical dimensions and properties are not explicitly stated, but the tests were performed per ASTM D6319-19 which would specify sample requirements).
- Sample Size for Chemotherapy Permeation Test: Not explicitly stated, but the test was conducted according to ASTM D6978-05 (Reapproved 2019), which would define the sample size requirements.
- Data Provenance: The tests were conducted to support the 510(k) submission, implying prospective testing specific to this device. No country of origin for the data itself is mentioned, but the manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device and study. The "ground truth" here is defined by objective physical and chemical testing standards (ASTM standards), not by expert consensus or interpretation of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes. The tests performed are objective, laboratory-based measurements against established 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
- This information is not applicable as this is not a study involving AI or human readers for diagnostic purposes. It's a non-clinical performance evaluation of gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" is established by objective, standardized laboratory test methods and their defined acceptance criteria as detailed in ASTM D6319-19 for physical properties and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. There is no expert consensus, pathology, or outcomes data involved in these specific tests.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
- This information is not applicable. Since there is no training set mentioned, there's no ground truth for it.
In summary: The provided document details the non-clinical performance evaluation of disposable nitrile exam gloves against recognized industry standards (ASTM D6319-19 and ASTM D6978-05) to assess their physical properties and resistance to chemotherapy drugs. The evaluation focuses on objective measurements rather than clinical or AI-driven assessments.
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