(242 days)
The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document pertains to the 510(k) premarket notification for "Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K192954). The information provided is primarily focused on the non-clinical performance data of these gloves, specifically their resistance to permeation by chemotherapy drugs and fentanyl citrate, as well as their general physical properties and biocompatibility.
The request asks for information relevant to the acceptance criteria and study proving a device meets acceptance criteria, typically in the context of an AI/ML medical device. The provided document is for a physical medical device (examination gloves) and not an AI/ML-driven device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.
However, I can extract the relevant information regarding acceptance criteria and how the performance of these gloves was evaluated based on the provided text.
Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)
The device performance was evaluated against established industry standards for examination gloves. The primary performance criteria highlighted are related to the permeation of chemotherapy drugs and fentanyl citrate, as well as general physical characteristics and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Standard / Methodology | Acceptance Criteria | Reported Device Performance | Comparison / Notes |
|---|---|---|---|---|
| Physical Properties | ASTM D412-2016 | Tensile Strength (Min 14 MPa), Elongation (Min 400%) | Pass | Similar to predicate, meets standard. |
| Water Leak Test | ASTM D5151-2006 | AQL 1.5 (ISO 2859-1) | Pass | Same as predicate, meets standard. |
| Powder Residue | ASTM D6124-2006 | Max 2 mg/glove | Pass | Similar to predicate, meets standard. |
| Chemotherapy Drug Permeation (Individual Drugs) | ASTM D6978-2005 | ≥ 240 minutes (for most drugs) | Cisplatin: ≥ 240 min | |
| Cyclophosphamide (Cytoxan): ≥ 240 min | ||||
| Dacarbazine (DTIC): ≥ 240 min | ||||
| Doxorubicin Hydrochloride: ≥ 240 min | ||||
| Etoposide (Toposar): ≥ 240 min | ||||
| Fluorouracil: ≥ 240 min | ||||
| Paclitaxel (Taxol): ≥ 240 min | ||||
| Carmustine (BCNU): 18.2 min | ||||
| Thiotepa (THT): 57.3 min | For most drugs, the acceptance criteria was met or exceeded. Carmustine and Thiotepa had significantly lower breakthrough times, leading to specific warnings. The reported times for these two drugs were slightly higher than the predicate's reported times (15 min and 2 min, respectively), indicating a marginal improvement for the subject device. | |||
| Fentanyl Citrate Permeation | ASTM D6978-2005 | ≥ 240 minutes | ≥ 240 minutes | Meets acceptance criteria. |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010 | Non-irritating | Passes: Non-irritating | Same as predicate, meets standard. |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010 | Non-sensitization | Passes: Non-sensitization | Same as predicate, meets standard. |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Cytotoxicity reactivity defined (not a simple pass/fail, depends on concentration) | Exhibits severe cytotoxicity reactivity at 100% and 66% extract concentrations and no cytotoxicity reactivity at 44%, 30%, 20%, and 15% extract concentrations. | Different from predicate (-), which implies the predicate either wasn't tested or had different results for cytotoxicity. The specific "acceptance criteria" isn't strictly a "pass" result in all concentrations but rather a characterization of the reactivity. |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017 | No adverse biological reaction | Passes: No adverse biological reaction. | Different from predicate (-), implying the predicate either wasn't tested or had different results for acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., number of gloves tested for permeation, water leak, or biocompatibility). The results are presented as "Pass" or average breakthrough times, which implies testing was conducted on a sufficient number of samples according to the respective ASTM/ISO standards.
- Data Provenance: The device manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., is located in Matang, Perak, Malaysia. The tests were conducted according to international standards (ASTM, ISO), but the specific laboratory location is not detailed. The data is non-clinical performance data, generated from laboratory testing, not human patient data (retrospective/prospective healthcare records).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the document describes a physical medical device (gloves) and their material/chemical resistance testing, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or data. Performance is determined by established engineering and chemical testing standards.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as above. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert consensus for AI/ML performance evaluation, not for laboratory testing of a physical product's material properties.
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 question is not applicable as this submission is for a physical medical device (gloves) and not an AI/ML-driven device or an AI-assisted human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as this is not an algorithm or AI-driven device. The "standalone" performance refers to the intrinsic properties of the glove material against chemical permeation and physical stress.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by well-defined, internationally recognized laboratory testing standards and methods (e.g., ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151 for water leak, ISO 10993 for biocompatibility). These standards specify the experimental procedures and often the criteria for "pass" or "fail" for the material properties of the gloves. The "truth" is based on the physical and chemical behavior observed under these controlled experimental conditions.
8. The Sample Size for the Training Set
- This question is not applicable as this is not an AI/ML device. There is no "training set" in the context of device performance, but rather test samples used for validation against defined standards.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reason as above.
§ 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.