(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2024
Nephron Nitrile, LLC. Lou Kennedy CEO/President/Manager 4777 12th Street Extension West Columbia, South Carolina 29172
Re: K233970
Trade/Device Name: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: December 15, 2023 Received: December 15, 2023
Dear Lou Kennedy:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233970
Device Name
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentany()
Indications for Use (Describe)
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)
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Prescription Use (Part 21 CFR 801 Subpart D)
- 区 Over-The-Counter Use (21 CFR 801 Subpart C)
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A. APPLICANT INFORMATION
| 510(K) Owner's Name | Nephron Nitrile, LLC. |
|---|---|
| Address | 4777 12th Street Extension, West Columbia, SC29172. |
| Phone | 844-937-3888 |
| Fax | 1-803-926-9853 |
| lkennedy@nephronpharm.comNitrileRegulatory@nephronnitrile.com | |
| Contact Person | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | lkennedy@nephronpharm.comNitrileRegulatory@nephronnitrile.com |
| Preparation date | 28 September 2023 |
| Date Submitted | 15 December 2023 |
B. DEVICE IDENTIFICATION
| Name of the device | Nephron Nitrile™, Nitrile Powder-FreeExamination Blue Gloves (Tested For Use WithChemotherapy Drugs and Fentanyl) |
|---|---|
| 510(k) Number | K233970 |
| Product proprietary or trade name | Nephron Nitrile™ |
| Common or usual name | Nitrile Examination Glove (Tested For Use WithChemotherapy Drugs and Fentanyl) |
| Classification name | Non-Powdered Patient Examination Glove,Specialty |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, OPJ, QDO |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Nephron Nitrile Powder-Free Nitrile ExaminationGloves (Tested For Use With ChemotherapyDrugs and Fentanyl) |
|---|---|
| 510(k) Number | K231349 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC, OPJ, QDO |
| Manufacturer | Nephron Nitrile, LLC. |
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D. DESCRIPTION OF THE DEVICE:
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.
E. INDICATION FOR USE OF THE DEVICE:
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 | The tested | ||
|---|---|---|---|
| 240 minutes: | Opioid is: | ||
| 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) | FentanylCitrateInjection(100 mcg/2 mL)Permeation: nobreakthroughup to 240minutes |
| The following chemotherapy drugs have low permeation times:Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutesWarning: Not for Use with: Carmustine, Thiotepa |
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | SUBJECT | ||||
| 510(K) Number | --- | K231349 | K23970 | ||
| Name of device | --- | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested For Use WithChemotherapy Drugs andFentanyl) | Nephron Nitrile™, NitrilePowder-Free ExaminationBlue Gloves (Tested For UseWith Chemotherapy Drugsand Fentanyl) | Similar | |
| Product Code | --- | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Identical | |
| Indication for use | --- | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested For Use WithChemotherapy Drugs andFentanyl) is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs andfentanyl in accordance withASTM D6978-05 (2019)Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs. | Nephron Nitrile™, NitrilePowder-Free ExaminationBlue Gloves (Tested For UseWith Chemotherapy Drugsand Fentanyl) is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs andfentanyl in accordance withASTM D6978-05 (2019)Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs. | Identical | |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical | |
| Material | --- | Nitrile | Nitrile | Identical | |
| Color | --- | Blue Gloves | Blue | Identical | |
| Size | --- | M, L, XL, XXL | XS, S, M, L, XL, XXL | Similar | |
| Adding size XS and S | |||||
| Single Use | --- | Single-use | Single-use | Identical | |
| Sterile/Non-sterile | --- | Non-Sterile | Non-Sterile | Identical | |
| Rx Only or OTC | --- | OTC | OTC | Identical | |
| CHARACTERISTICS | DEVICE PERFORMANCE | Comparison | |||
| 510(K) Number | STANDARDS | PREDICATE | SUBJECT | ||
| K231349 | --- | K231349 | K23970 | ||
| Dimensions - Length | ASTM D6319-19 | Minimum 230 mm(sizes M – XXL) | Minimum 220 mm(Sizes XS-S)Minimum 230 mm(sizes M – XXL) | SimilarAdding size XS and S | |
| Dimensions - Width | ASTM D6319-19 | M: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | XS: 70±10 mmS: 80±10 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | SimilarAdding size XS and S | |
| Physical Properties-Tensile Strength | ASTM D6319-19 | Before aging14MPa, minAfter aging14MPa, min | Before aging14MPa, minAfter aging14MPa, min | Identical | |
| Physical Properties-Ultimate Elongation | ASTM D6319-19 | Before aging500%, minAfter aging400%, min | Before aging500%, minAfter aging400%, min | Identical | |
| Thickness | ASTM D6319-19 | Palm: Minimum0.05 mmFinger: Minimum0.05 mm | Palm: Minimum0.05 mmFinger: Minimum0.05 mm | Identical | |
| Powder Free Residue | ASTM D6319-19 | ≤2 mg per glove | ≤ 2 mg per glove | Identical | |
| Freedom from holes | ASTM D5151-2019 | In accordance withASTM D 5151-19,following ASTM D6319-19,G-I, AQL 2.5 | In accordance withASTM D 5151-19,following ASTM D6319-19,G-I, AQL 2.5 | Identical | |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | ASTM D6978-05 (2019) | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 MinutesBusulfan6 mg/ml (6,000 ppm)>240 MinutesCarboplatin10 mg/ml (10,000 ppm)>240 MinutesCarmustine3.3 mg/ml (3,300 ppm)33.8 MinutesCisplatin1 mg/ml (1,000 ppm)>240 MinutesCyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 MinutesBusulfan6 mg/ml (6,000 ppm)>240 MinutesCarboplatin10 mg/ml (10,000 ppm)>240 MinutesCarmustine3.3 mg/ml (3,300 ppm)33.8 MinutesCisplatin1 mg/ml (1,000 ppm)>240 MinutesCyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Identical | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| 510(K) Number | --- | PREDICATE | SUBJECT | ||
| K231349 | K23970 | ||||
| Cytarabine100 mg/ml (100,000 ppm)>240 Minutes | Cytarabine100 mg/ml (100,000 ppm)>240 Minutes | Identical | |||
| Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | Identical | |||
| Daunorubicin HCl5 mg/ml (5,000 ppm)>240 Minutes | Daunorubicin HCl5 mg/ml (5,000 ppm)>240 Minutes | Identical | |||
| Docetaxel10 mg/ml (10,000 ppm)>240 Minutes | Docetaxel10 mg/ml (10,000 ppm)>240 Minutes | Identical | |||
| Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Identical | |||
| Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Identical | |||
| Etoposide20 mg/ml (20,000 ppm)>240 Minutes | Etoposide20 mg/ml (20,000 ppm)>240 Minutes | Identical | |||
| Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | Identical | |||
| Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | Identical | |||
| Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | Identical | |||
| Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | Identical | |||
| Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | Identical | |||
| Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | Identical | |||
| Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | Identical | |||
| Melphalan5 mg/ml (5,000 ppm)>240 Minutes | Melphalan5 mg/ml (5,000 ppm)>240 Minutes | Identical | |||
| Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | Identical | |||
| Mitomycin C0.5 mg/ml (500 ppm)>240 Minutes | Mitomycin C0.5 mg/ml (500 ppm)>240 Minutes | Identical | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| PREDICATE | SUBJECT | ||||
| 510(K) Number | K231349 | K23970 | |||
| Mitoxantrone HCl2 mg/ml (2,000 ppm)>240 Minutes | Mitoxantrone HCl2 mg/ml (2,000 ppm)>240 Minutes | Identical | |||
| Paclitaxel6 mg/ml (6,000 ppm)>240 Minutes | Paclitaxel6 mg/ml (6,000 ppm)>240 Minutes | Identical | |||
| Rituximab 10 mg/ml(10,000 ppm)>240 Minutes | Rituximab 10 mg/ml(10,000 ppm)>240 Minutes | Identical | |||
| Thiotepa10 mg/ml (10,000 ppm)128.1 Minutes | Thiotepa10 mg/ml (10,000 ppm)128.1 Minutes | Identical | |||
| Trisenox1 mg/ml (1,000ppm) >240Minutes | Trisenox1 mg/ml (1,000ppm)>240 Minutes | Identical | |||
| Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | Identical | |||
| Opioid DrugsTested with MinimumBreakthrough DetectionTime | ASTM D6978-05 (2019) | Fentanyl Citrate Injection(100mcg/2mL)>240 Minutes | Fentanyl Citrate Injection(100mcg/2mL)>240 Minutes | Identical | |
| Biocompatibility | Primary SkinIrritation- ISO10993-23:First Edition2021-01 | Under the conditions of thestudy, the test articlemet the requirements ofthe test. | Under the conditions of thestudy, the test articlemet the requirements ofthe test. | Identical | |
| DermalSensitization-ISO 10993-10:Fourth Edition2021-11 | Under the conditions of thestudy, the test article was notconsidered a sensitizer. | Under the conditions of thestudy, the test article was notconsidered a sensitizer. | Identical | ||
| In vitrocytotoxicity-ISO 10993-5:Third Edition2009-06-01 | Under the Conditions of thestudy, theundiluted test article extractand 50% test article extractdilution didnot meet the requirements ofthe test and the 25%, 12.5%,6.25%, and3.13% test article extractdilutions metthe requirements of the test. | Under the conditions of thestudy, theundiluted test articleextract and 50% test articleextract dilution didnot meet the requirements ofthe test and the 25%,12.5%, 6.25%, and3.13% test article extractdilutions metthe requirements of the test. | Identical | ||
| AcuteSystemicToxicity- ISO10993-11:Third Edition2017-09 | Under the conditions of thestudy, there was no mortalityor evidence of systemictoxicity | Under the conditions of thestudy, there was no mortalityor evidence of systemictoxicity | Identical |
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AS REQUIRED BY: 21CFR§807.92
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AS REQUIRED BY: 21CFR§807.92
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AS REQUIRED BY: 21CFR§807.92
- Identical except for the expansion of glove sizes to include XS and S while maintaining existent M to XXL, which is the subject of this submission.
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AS REQUIRED BY: 21CFR§807.92
There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319-19 and D6978-05 (2019).
G. NON-CLINICAL TESTING SUMMARY
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication. | To determine thelength of the gloves | Extra-Small: 220 mm minSmall: 220 mm minMedium: 230 mm minLarge : 230 mm minX-Large : 230 mm minXX-Large : 230 mm min | Extra-Small: 242 mmSmall: 243 mmMedium: 235 mm*Large: 237 mm*X-Large: 250 mm*XX-Large: 238 mm* | |||||||||||||||||||||
| ASTM D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication. | To determine thewidth of the gloves | XS: 70±10 mmS: 80±10 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | Extra-Small: 74 mmSmall: 85 mmMedium: 95 mm*Large: 113 mm*X-Large: 121 mm*XX-Large: 129 mm* | |||||||||||||||||||||
| ASTM D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Palm: 0.05 mm minfor all sizesFinger: 0.05 mm minfor all sizes | Size Palm Finger Extra-Small 0.112 mm 0.145 mm Small 0.095 mm 0.115 mm Medium* 0.077 mm 0.111 mm Large* 0.106 mm 0.109 mm X-Large* 0.089 mm 0.115 mm XX-Large* 0.113 mm 0.107 mm | |||||||||||||||||||||
| ASTM D6319-19Standard Specification forNitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa min for all sizesAfter AgeingTensile Strength14MPa min for all sizes | Size Beforeageing Afterageing Extra-Small 33.74MPa 35.99MPa Small 32.35MPa 32.14MPa The results for Medium, Large, X-Large and XX-Large are the same asthe predicate. | |||||||||||||||||||||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% min for all sizesAfter AgeingUltimate Elongation400% min for all sizes | Size Beforeageing Afterageing Extra-Small 565% 514% Small 538% 435% The results for Medium, Large, X-Large and XX-Large are the same asthe predicate. |
BENCH TEST DATA
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| ASTM D5151-19Standard Test Method forDetection of Holes inMedical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
|---|---|---|---|
| ASTM D6124-06(Reapproved 2017)Standard Test Method forResidual Powder onMedical Gloves | To determine theresidual powder inthe gloves | $\u2264$ 2 mg/glove | Extra-Small: 0.822 mg/gloveSmall: 0.147 mg/gloveThe results for Medium, Large, X-Large and XX-Large are the same asthe predicate. |
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs. | To determine thebreakthroughdetection time ofchemotherapydrugs | Bleomycin Sulfate 15mg/ml(15,000 ppm) >240 Minutes | Bleomycin Sulfate 15 mg/ml(15,000 ppm) >240 Minutes |
| Busulfan 6 mg/ml(6,000 ppm) >240 Minutes | Busulfan 6 mg/ml(6,000 ppm) >240 Minutes | ||
| Carboplatin 10 mg/ml(10,000 ppm)>240 Minutes | Carboplatin 10 mg/ml(10,000 ppm)>240 Minutes | ||
| Carmustine 3.3 mg/ml(3,300 ppm) >240 Minutes | Carmustine 3.3 mg/ml(3,300 ppm) >240 Minutes | ||
| Cisplatin 1 mg/ml(1,000 ppm) >240 Minutes | Cisplatin 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Cyclophosphamide 20 mg/ml(20,000 ppm) >240 Minutes | Cyclophosphamide 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Cytarabine 100 mg/ml(100,000 ppm) >240 Minutes | Cytarabine 100 mg/ml(100,000 ppm) >240 Minutes | ||
| Dacarbazine 10 mg/ml(10,000 ppm)>240 Minutes | Dacarbazine 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Daunorubicin HCl 5 mg/ml(5,000 ppm) >240 Minutes | Daunorubicin HCl 5 mg/ml(5,000 ppm) >240 Minutes | ||
| Docetaxel 10 mg/ml(10,000 ppm)>240 Minutes | Docetaxel 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Doxorubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | Doxorubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Epirubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | Epirubicin HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Etoposide 20 mg/ml(20,000 ppm) >240 Minutes | Etoposide 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Fludarabine 25 mg/ml(25,000 ppm) >240 Minutes | Fludarabine 25 mg/ml(25,000 ppm) >240 Minutes | ||
| Fluorouracil 50 mg/ml(50,000 ppm) >240 Minutes | Fluorouracil 50 mg/ml(50,000 ppm) >240 Minutes | ||
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | To determine thebreakthroughdetection time ofOpioiddrugs | Gemcitabine 38 mg/ml(38,000 ppm) >240 MinutesIdarubicin HCl 1 mg/ml(1,000 ppm) >240 MinutesIfosfamide 50 mg/ml(50,000 ppm) >240 MinutesIrinotecan 20 mg/ml(20,000 ppm) >240 MinutesMechlorethamine HCl 1 mg/ml(1,000 ppm) >240 MinutesMelphalan 5 mg/ml(5,000 ppm) >240 MinutesMethotrexate 25 mg/ml(25,000 ppm) >240 MinutesMitomycin C 0.5 mg/ml(500 ppm) >240 MinutesMitoxantrone HCl 2 mg/ml(2,000 ppm) >240 MinutesPaclitaxel 6 mg/ml(6,000 ppm) >240 MinutesRituximab 10 mg/ml(10,000 ppm) >240 MinutesThiotepa 10 mg/ml(10,000 ppm) >240 MinutesTrisenox 1 mg/ml(1,000 ppm) >240 MinutesVincristine Sulfate 1 mg/ml(1,000 ppm) >240 MinutesFentanyl Citrate Injection(100mcg/2mL) >240 Minutes | Gemcitabine 38 mg/ml(38,000 ppm) >240 MinutesIdarubicin HCl 1 mg/ml(1,000 ppm) >240 MinutesIfosfamide 50 mg/ml(50,000 ppm) >240 MinutesIrinotecan 20 mg/ml(20,000 ppm) >240 MinutesMechlorethamine HCl 1 mg/ml(1,000 ppm) >240 MinutesMelphalan 5 mg/ml(5,000 ppm) >240 MinutesMethotrexate 25 mg/ml(25,000 ppm) >240 MinutesMitomycin C 0.5 mg/ml(500 ppm) >240 MinutesMitoxantrone HCl 2 mg/ml(2,000 ppm) >240 MinutesPaclitaxel 6 mg/ml(6,000 ppm) >240 MinutesRituximab 10 mg/ml(10,000 ppm) >240 MinutesThiotepa 10 mg/ml(10,000 ppm) >240 MinutesTrisenox 1 mg/ml(1,000 ppm) >240 MinutesVincristine Sulfate 1 mg/ml(1,000 ppm) >240 MinutesFentanyl Citrate Injection(100mcg/2mL) >240 Minutes |
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AS REQUIRED BY: 21CFR§807.92
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BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 First edition2021-01 BiologicalEvaluation of MedicalDevices - Part 23, Tests forIrritation. | To evaluate the localdermal irritation of a testarticle extract followingintracutaneous injection inrabbits. | Under the condition ofstudy not an irritant | Under the conditions of thestudy, the test article met therequirements of the test |
| 10993-10 Fourth edition2021-11 BiologicalEvaluation of MedicalDevices - Part 10, Tests forSkin Sensitization. | To evaluate the test item,for the skin sensitizationin Guinea pigs bymaximization test. | Under the conditions ofthe study, not asensitizer | Under the conditions of thestudy, the test article was notconsidered a sensitizer |
| ISO 10993-5 Third Edition2009-06-01 BiologicalEvaluation of MedicalDevices - Part 5, Tests forIn Vitro Cytotoxicity. | To determine the potentialof a test article to causecytotoxicity | Under the conditions ofthe study, non-cytotoxic | The undiluted test articlesextract and 50% test articleextract dilution did not meetthe requirements of the testand the 25%, 12.5%, 6.25%,and 3.13% test article extractdilutions met therequirements of the test.Cytotoxicity concern wasaddressed by acute systemictoxicity testing. |
| ISO 10993-11 Third edition2017-09 BiologicalEvaluation of MedicalDevices - Part 11, Tests forSystemic Toxicity. | To evaluate the acutesystemic toxicity of a testarticle, extract followinginjection in mice. | Under the conditions ofstudy, the device extractsdo not pose a systemictoxicity concern | Under the conditions of study,there was no mortality orevidence of systemic toxicity |
The following non-clinical tests were performed:
- ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical ● Gloves.
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of ● Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation.
- . ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
- ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices Part 5, ● Tests for In Vitro Cytotoxicity.
- ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
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H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission K233970, Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl), is as safe, as effective, and performs as well as or better than the legally marketed predicate device K231349.
§ 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.