(86 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 and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a Class I medical device, which means it is subject to general controls and does not require approval of a premarket approval application (PMA). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K192954).
The acceptance criteria and study proving the device meets these criteria are based on non-clinical performance data, as no clinical performance data was provided or required for this device type.
Acceptance Criteria and Device Performance Study
The device's performance was evaluated against various ASTM and ISO standards for medical examination gloves, particularly focusing on their physical properties and resistance to permeation by chemotherapy drugs and Fentanyl Citrate.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions: Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | 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 | Physical Dimensions: Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% min, After Aging 400% min), Min AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water Leak Test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to specific Minimum Breakthrough Detection Time (BDT) for each drug (as listed in section "Chemotherapy Permeation and Fentanyl Citrate Comparison Claim" on pages 8-9 of the document). For most drugs, the criterion is >240 minutes, with the exception of Carmustine and Thio Tepa. | Pass (Results shown in detail in the provided tables in the document, page 2 and 5-6). For Carmustine: 11.1 min (met its specific criterion). For Thio Tepa: 21.6 min (met its specific criterion). Fentanyl Citrate Injection: >240 min. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | Non-sensitizing and Non-irritating | Non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity evaluated | Showed potential toxicity to L929 cells (concern addressed by acute systematic toxicity testing). |
| ISO 10993-11:2017 | Acute Systemic Toxicity Study | No adverse biological reaction | No evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for water leaks, chemical permeation). However, the tests were conducted according to established industry standards such as ASTM and ISO, which typically define appropriate sample sizes for such evaluations.
The data provenance is based on non-clinical laboratory testing performed by or for Better Care Plastic Technology Co., Ltd. The owner's identification indicates their address as "Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China," suggesting the tests took place in China. The data is retrospective in the sense that it represents completed laboratory tests submitted for the 510(k) application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. For non-clinical validation of gloves, "ground truth" is typically established by adherence to established test methodologies (ASTM, ISO standards) and the measured physical/chemical properties, rather than expert consensus on subjective evaluations. The "experts" would be the certified laboratories and technicians performing these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the validation involves standardized physical and chemical property testing, not subjective human evaluation requiring adjudication.
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 relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This document pertains to physical medical devices (examination gloves), for which MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable to a physical medical device like an examination glove. The "performance" being evaluated is the glove's physical and chemicalbarrier properties, not an algorithm's output.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM D6319-19 for physical dimensions, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the acceptable range or threshold for a given property.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (nitrile gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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.