(30 days)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger 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.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.
Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.
However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.
Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.
| Referenced Standards / Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319-19) | Passed | |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass (All size ≥290mm reported in 510(k) Summary, page 5) |
| Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass (Reported ranges: XS: 76-78mm; S: 86-88 mm; M: 96-98mm; L: 106-108 mm; XL: 116-118 mm; XXL: 126-128 mm) |
| Thickness (Finger & Palm) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass (Reported ranges: Palm: 0.09-0.11mm; Finger: 0.13-0.14mm) |
| Physical Properties (ASTM D6319-19, ASTM D412-16 (2021)) | Passed | |
| Tensile Strength (Before Aging) | Min 14 MPa | Pass (Reported range: 15.8-20.8 MPa) |
| Tensile Strength (After Accelerated Aging) | Min 14 MPa | Pass (Reported range: 15.6-19.8 MPa) |
| Ultimate Elongation (Before Aging) | Min 500% | Pass (Reported range: 500-560%) |
| Ultimate Elongation (After Accelerated Aging) | Min 400% | Pass (Reported range: 400-500%) |
| Freedom from holes (ASTM D6319-19, ASTM D5151-19) | G-I, AQL 2.5 | Pass (Meet AQL2.5 requirements) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2 mg/glove | Pass (≤ 2 mg, meet requirements) |
| Chemical Permeation (ASTM D6978-05 (2019)) | Passed (Refer to specific drug breakdown for values) | |
| Chemotherapy Drugs | See "Indications for Use" table on pages 3 and 6, and "Chemotherapy Permeation Comparison Claim" table on pages 7-8 for specific minimum BDTs for 15 listed drugs. | All reported BDTs met or exceeded the minimum requirements. For example, Carmustine (BCNU) had a BDT of 54.3 min (meeting criteria), and many others had >240 min. |
| Opioid Drug (Fentanyl Citrate Injection) | Minimum BDT >240 minutes | >240 minutes |
| Biocompatibility (ISO 10993-10:2010) | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| Biocompatibility (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.
The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.
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 physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:
- Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
- Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
- Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
- Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
- Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.