(32 days)
Nephron Nitrile™. Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes Warning: Not for Use with: Carmustine, Thiotepa The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL)
Nephron Nitrile™. Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). The powder-free gloves are made from Nitrile (NBR) latex and are blue in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Small, Medium, Large, X-Large and XX-Large.
This document describes the non-clinical testing performed for the Nephron Nitrile™ Nitrile Powder-Free Examination Blue Gloves to meet performance and safety criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 (Nitrile Examination Gloves for Medical Application) | Length of the gloves | Extra-Small: 220 mm min; Small: 220 mm min; Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | Extra-Small: 242 mm; Small: 243 mm; Medium: 235 mm; Large: 237 mm; X-Large: 250 mm; XX-Large: 238 mm |
| Width of the gloves | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm; XXL: 130±10 mm | Extra-Small: 74 mm; Small: 85 mm; Medium: 95 mm; Large: 113 mm; X-Large: 121 mm; XX-Large: 129 mm | |
| Thickness of the gloves | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Extra-Small: Palm 0.112 mm, Finger 0.145 mm; Small: Palm 0.095 mm, Finger 0.115 mm; Medium: Palm 0.077 mm, Finger 0.111 mm; Large: Palm 0.106 mm, Finger 0.109 mm; X-Large: Palm 0.089 mm, Finger 0.115 mm; XX-Large: Palm 0.113 mm, Finger 0.107 mm | |
| Physical properties - Tensile strength (Before aging) | 14MPa min for all sizes | Extra-Small: 33.74MPa; Small: 32.35MPa; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Tensile strength (After aging) | 14MPa min for all sizes | Extra-Small: 35.99MPa; Small: 32.14MPa; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Ultimate Elongation (Before aging) | 500% min for all sizes | Extra-Small: 565%; Small: 538%; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| Physical properties - Ultimate Elongation (After aging) | 400% min for all sizes | Extra-Small: 514%; Small: 435%; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) | |
| ASTM D5151-19 (Detection of Holes in Medical Gloves) | Holes in the gloves | AQL 2.5 | Gloves Pass AQL 2.5 |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder on Medical Gloves) | Residual powder in the gloves | ≤ 2 mg/glove | Extra-Small: 0.822 mg/glove; Small: 0.147 mg/glove; (Medium, Large, X-Large, XX-Large results are the same as predicate and meet criteria) |
| ASTM D6978-05 (Reapproved 2019) (Permeation by Chemotherapy Drugs) | Breakthrough detection time of chemotherapy drugs | Bleomycin Sulfate (15 mg/ml) >240 Minutes; Busulfan (6 mg/ml) >240 Minutes; Carboplatin (10 mg/ml) >240 Minutes; Cisplatin (1 mg/ml) >240 Minutes; Cyclophosphamide (20 mg/ml) >240 Minutes; Cytarabine (100 mg/ml) >240 Minutes; Dacarbazine (10 mg/ml) >240 Minutes; Daunorubicin HCl (5 mg/ml) >240 Minutes; Docetaxel (10 mg/ml) >240 Minutes; Doxorubicin HCl (2 mg/ml) >240 Minutes; Epirubicin HCl (2 mg/ml) >240 Minutes; Etoposide (20 mg/ml) >240 Minutes; Fludarabine (25 mg/ml) >240 Minutes; Fluorouracil (50 mg/ml) >240 Minutes; Gemcitabine (38 mg/ml) >240 Minutes; Idarubicin HCl (1 mg/ml) >240 Minutes; Ifosfamide (50 mg/ml) >240 Minutes; Irinotecan (20 mg/ml) >240 Minutes; Mechlorethamine HCl (1 mg/ml) >240 Minutes; Melphalan (5 mg/ml) >240 Minutes; Methotrexate (25 mg/ml) >240 Minutes; Mitomycin C (0.5 mg/ml) >240 Minutes; Mitoxantrone HCl (2 mg/ml) >240 Minutes; Paclitaxel (6 mg/ml) >240 Minutes; Rituximab (10 mg/ml) >240 Minutes; Thiotepa (10 mg/ml) >240 Minutes (Note: Product warning for Carmustine and Thiotepa based on previous data indicated low permeation times); Trisenox (1 mg/ml) >240 Minutes; Vincristine Sulfate (1 mg/ml) >240 Minutes | All listed chemotherapy drugs met the acceptance criteria of >240 minutes for breakthrough detection, except Carmustine (33.8 mins) and Thiotepa (128.1 mins) for which there is a warning (results are identical to the predicate). |
| Breakthrough detection time of Opioid drugs | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes (results are identical to the predicate) | |
| ISO 10993-23 (Tests for Irritation) | Local dermal irritation of a test article extract | Under the condition of study not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 (Tests for Skin Sensitization) | Skin sensitization in Guinea pigs by maximization test | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 (Tests for In Vitro Cytotoxicity) | Potential of a test article to cause cytotoxicity | Under the conditions of the study, non-cytotoxic | The undiluted test articles extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-11 (Tests for Systemic Toxicity) | Acute systemic toxicity of a test article, extract following injection | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance:
The document explicitly states "The results for Medium, Large, X-Large and XX-Large are the same as the predicate," indicating that for these sizes, existing data from the previous 510(k) submission (K231349) were leveraged. New testing was conducted for the added "Extra-Small" and "Small" sizes.
- Extra-Small and Small Sizes: Specific values are provided for these sizes, indicating new testing was performed for them. The document does not specify the exact number of gloves or samples tested for each physical property (length, width, thickness, tensile strength, ultimate elongation, residual powder, holes) for these new sizes, nor the number of replicates for the chemotherapy drug and opioid permeation tests for the subject device. However, these tests would typically follow the methodologies outlined in the referenced ASTM and ISO standards, which define appropriate sample sizes and testing protocols.
- Medium, Large, X-Large, and XX-Large Sizes: For these sizes, the results are stated to be "the same as the predicate," which implies that the data provenance for these sizes is from the previous 510(k) submission (K231349), and likely involved testing conducted per the same ASTM and ISO standards.
The document does not provide information on the country of origin of the data or whether it was retrospective or prospective, beyond indicating that newly generated data for XS and S sizes would be prospective for this submission, while data for other sizes are effectively retrospective from the predicate device.
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 to the type of device and testing performed. The "ground truth" here is defined by objective, standardized measurements against established ASTM and ISO performance criteria for medical gloves and their resistance to chemicals, not by expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical or imaging studies where subjective expert review is involved. The tests for medical gloves are objective and rely on physical measurements and chemical analysis conforming to recognized standards.
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 information is not applicable. MRMC studies are relevant for AI/ML-enabled diagnostic devices that rely on human-in-the-loop interpretation. The device in question is a medical glove, which is a physical barrier device, not a diagnostic tool assisted by AI/ML.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable, as it pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of these medical gloves is based on:
- Standardized Physical and Chemical Measurements: This includes quantitative measurements like length, width, thickness, tensile strength, ultimate elongation, residual powder, and breakthrough detection times for chemicals.
- Compliance with Recognized Standards: The acceptance criteria themselves are derived from established industry standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ASTM D6978-05 (Reapproved 2019), and ISO 10993 series for biocompatibility.
8. The sample size for the training set:
This information is not applicable. The device is a physical product (medical glove), and its performance is evaluated through non-clinical bench testing against established standards, not through training and testing of an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" in the context of this device's non-clinical evaluation.
§ 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.