(63 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319- 19 | To determine the length of the gloves | XS: ≥ 220 mm; S: ≥ 220 mm; M: ≥ 230 mm; L: ≥ 230 mm; XL: ≥ 230 mm; XXL: ≥ 230 mm | Pass |
| ASTM D6319- 19 | To determine the Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L:110±10mm; XL:120±10mm; XXL:130±10mm | Pass |
| ASTM D6319- 19 | To determine the Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19, ASTM D412-16(2021) | To determine the Physical Properties | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19, ASTM D6124-06 (2022) | To determine the Powder Residue | Max 2mg/glove | Pass |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | Under the conditions of this protocol, the test article did not elicit a sensitization response. |
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test result showed that the requirements of the ISO Intracutaneous Reactivity Test have been met by the test article. |
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity reactivity | The test article is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by Acute Systemic Injection Test. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No systemic toxicity | The test result indicates that the requirements of the ISO Acute Systemic Injection Test have been met by the test article. |
| ASTM D6978-05 (Reapproved 2019) | Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Minimum Breakthrough Detection Time for various chemotherapy drugs, Fentanyl Citrate, and other select drugs (specific values listed in the "Indications for Use" and "Chemotherapy Permeation, Fentanyl Citrate, and Select Other Drugs Comparison Claim" tables). | See detailed breakthrough times in original document, with most being >240 minutes, except for Carmustine and Thiotepa which have lower breakthrough times (e.g., Carmustine 11.7-15.3 min, Thiotepa 15.4-36.4 min). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.
- Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.
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 typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.
7. The Type of Ground Truth Used:
The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
- Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
- Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
- Freedom from holes is evaluated by ASTM D5151-19.
- Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).
8. The Sample Size for the Training Set:
This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.
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.
§ 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.