(90 days)
A patient examination 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 chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
The provided document describes the acceptance criteria and the study conducted for "Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs" and "Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs".
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Water Leak Test | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151. | pass |
| ASTM D3767 | Dimension | The actual measured dimension of the gloves shall meet the stated tolerance in Table 2 of the ASTM D 6319-19. | pass |
| Before aging ASTM D412, After aging ASTM D573 | Physical Properties (Tensile Strength, Ultimate Elongation) | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM 6319-19 (Tensile Strength: Before Aging ≥ 14 MPa, min.; After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min.; After Aging 400%, min.). | pass |
| ASTM D6124 | Residual Powder Content | The powder residue content shall be not more than 2mg per gloves. | pass |
| ASTM D6978-05 | Chemotherapy Drugs Permeation Time | Carmustine (BCNU) 3.3 mg/ml: 65.3 minutes | |
| Cisplatin 1.0 mg/ml: >240 minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 minutes | |||
| Dacarbazine (DTIC)10.0 mg/ml: >240 minutes | |||
| Doxorubicin Hydrochloride 2.0 mg/ml: >240 minutes | |||
| Etoposide (Toposar) 20.0 mg/ml: >240 minutes | |||
| Fluorouracil 50.0 mg/ml: >240 minutes | |||
| Paclitaxel (Taxol) 6.0 mg/ml: >240 minutes | |||
| Thiotepa 10.0 mg/ml: 58.3 minutes | pass | ||
| ISO 10993-10:2010 | Skin Irritation | non-irritating | pass |
| ISO 10993-10:2010 | Skin Sensitization | non-sensitizing | pass |
| ISO 10993-11:2017 | Acute Systemic Toxicity | No acute system toxicity | pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or individual tests) used for each non-clinical test. It only states that "Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications."
The data provenance is from non-clinical laboratory testing conducted to established international and ASTM standards. The country of origin of the data is not explicitly stated for each test, but the devices are manufactured by GUANGDONG KINGFA SCI. & TECH.CO., LTD. in Qingyuan, Guangdong, China. The testing appears to be prospective as it was performed to verify the device's compliance.
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. The study involves non-clinical performance testing of medical devices (gloves), not a diagnostic algorithm or human-readable data necessitating expert ground truth establishment. The "ground truth" here is determined by the objective measurements and adherence to the specified ASTM and ISO standards.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For non-clinical device testing, the results are objectively measured against predefined criteria.
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
There was no MRMC comparative effectiveness study done. This study is for medical gloves, which are physical devices, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This study concerns a physical medical device (gloves), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this non-clinical testing is based on objective measurements and adherence to established international standards such as ASTM D6319-19, ASTM D6978-05, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, chemical permeation resistance, and biocompatibility of the gloves.
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 algorithm development study.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device testing.
§ 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.