(28 days)
Nephron Nitrile Powder-Free Nitrile Examination 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.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a 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). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
This document is a 510(k) Premarket Notification from the FDA for medical gloves, specifically "Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)". It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with non-clinical testing results to demonstrate substantial equivalence.
Here's an analysis based on your request, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria and performance data are primarily described in the "NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA" and "BIOCOMPATIBILITY DATA" sections (pages 9-12).
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 (Dimensions - Length) | To determine the length of the gloves | Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | Medium: 235 mm; Large: 237 mm; X-Large: 250 mm; XX-Large: 238 mm |
| ASTM D6319-19 (Dimensions - Width) | To determine the width of the gloves | Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm; XX-Large: 130+/-10 mm | Medium: 95; Large: 113; X-Large: 121; XX-Large: 129 |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | 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 |
| ASTM D6319-19 (Physical Properties - Tensile Strength) | To determine the physical properties - Tensile strength | Before Ageing: 14MPa min for all sizes; After Ageing: 14MPa min for all sizes | Medium: Before Ageing 34.0 MPa, After Ageing 37.3 MPa (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D6319-19 (Physical Properties - Ultimate Elongation) | To determine the physical properties - Ultimate Elongation | Before Ageing: 500% min for all sizes; After Ageing: 400% min for all sizes | Medium: Before Ageing 542%, After Ageing 503% (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D5151-19 | To determine the holes in the gloves | AQL 2.5 | Gloves Pass AQL 2.5 |
| ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | ≤ 2 mg/glove | Medium: 0.3516 mg/glove (Only Medium size result provided, table formatting appears to omit others) |
| ASTM D6978-05 (Reapproved 2019) (Chemotherapy Drugs) | To determine the breakthrough detection time of chemotherapy drugs | Generally ">240 Minutes" for most listed drugs (e.g., Bleomycin Sulfate 15mg/ml >240 Minutes, Busulfan 6 mg/ml >240 Minutes, Carboplatin 10 mg/ml >240 Minutes, etc.) With specific lower times for Carmustine (33.8 mins) and Thiotepa (128.1 mins), and a "Warning: Not for Use with: Carmustine, Thiotepa" based on these low permeation times. | Results matched acceptance criteria: ">240 Minutes" for the majority of listed drugs, and the specified lower times for Carmustine (33.8 mins) and Thiotepa (128.1 mins) were reported. |
| ASTM D6978-05 (Reapproved 2019) (Opioid Drugs) | To determine the breakthrough detection time of Opioid drugs | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection (100mcg/2mL) >240 Minutes |
| ISO 10993-23 First edition 2021-01 (Irritation) | To evaluate the 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 Fourth edition 2021-11 (Skin Sensitization) | To evaluate the test item for skin sensitization | 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 Third edition 2009-06-01 (In Vitro Cytotoxicity) | To determine the potential of a test article to cause cytotoxicity | Under the conditions of the study, non-cytotoxic | The undiluted test article 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. (Note: This result indicates that higher concentrations were not non-cytotoxic, but the justification points to systemic toxicity testing to mitigate this concern.) |
| ISO 10993-11 Third edition 2017-09 (Acute Systemic Toxicity) | To evaluate the acute systemic toxicity of a test article extract | 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 does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for permeation, dimensions, etc.) beyond what's implied by the AQL 2.5 for freedom from holes (which dictates the sampling plan based on lot size, but the lot size isn't provided).
- Data Provenance: The studies were non-clinical bench tests and biocompatibility tests performed to established ASTM and ISO standards. The location where these tests were conducted is not specified in this FDA letter, but typically these are performed in certified laboratories. The data is prospective, in the sense that the tests were conducted specifically to demonstrate the performance of the device for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a 510(k) submission for an examination glove, which is a Class I medical device. The "ground truth" for these tests are established by widely accepted international and national standards (ASTM and ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, chemistry, toxicology, medical device manufacturing, etc.), and the laboratories performing the tests follow strict protocols defined by these standards.
The document does not mention the use of individual human experts (like radiologists for imaging studies) to establish "ground truth" for the performance or safety of the glove itself in the way that would apply to, for example, an AI diagnostic aid. The "ground truth" for the glove's performance is derived directly from the application of the specified physical, chemical, and biological test methods.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and testing. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective expert review processes, such as interpreting medical images or clinical outcomes. For the physical and chemical property tests of a glove, the results are quantitative measurements or pass/fail criteria against a defined standard, not subject to human interpretation discrepancies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) perform tasks with and without AI assistance to measure the AI's impact on human performance. This document pertains to a physical medical device (examination glove), not an AI diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a glove, not an algorithm. The performance tests are "standalone" in the sense that they measure the intrinsic properties of the glove itself.
7. The Type of Ground Truth Used
The ground truth for this device is based on defined physical, chemical, and biological performance standards and test methodologies (e.g., ASTM D6319-19 for glove properties, ASTM D6978-05 for chemical permeation resistance, ISO 10993 series for biocompatibility). These standards specify the methods for measuring parameters like tensile strength, freedom from holes, chemical breakthrough time, and biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).
8. The Sample Size for the Training Set
Not applicable. This document is about a physical medical device (glove), not a machine learning or AI model. Therefore, 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 this type of medical device submission.
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June 6, 2023
Nephron Nitrile, LLC. Lou Kennedy Chief Executive Officer 4777 12th Street Extension West Columbia, South Carolina 29172
Re: K231349
Trade/Device Name: Nephron Nitrile Powder-Free Nitrile Examination 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: May 9, 2023 Received: May 9, 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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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) K231349
Device Name
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Indications for Use (Describe)
Nephron Nitrile Powder-Free Nitrile Examination 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) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
|---|---|---|
| Busulfan (6.0 mg/ml) | Epirubicin HCl (2.0 mg/ml) | Melphalan (5.0 mg/ml) |
| Carboplatin (10.0 mg/ml) | Etoposide (20.0 mg/ml) | Methotrexate (25.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Fludarabine (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Fluorouracil (50.0 mg/ml) | Mitoxantrone HCl (2.0 mg/ml) |
| Cytarabine (100.0 mg/ml) | Gemcitabine (38.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Dacarbazine (10.0 mg/ml) | Idarubicin HCl (1.0 mg/ml) | Rituximab (10.0 mg/ml) |
| Daunorubicin HCl (5.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Trisenox (1.0 mg/ml) |
| Docetaxel (10.0 mg/ml) | Irinotecan (20.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |
The following chemotherapy drugs have low permeation times: Thiotepa (10.0 mg/ml) : 128.1 minutes Carmustine (3.3 mg/ml) : 33.8 minutes
Warning: Not for Use with: Carmustine, Thiotepa
The tested Opioid is:
Fentanyl Citrate Injection (100 mcg/2 mL). Permeation: no breakthrough up to 240 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X 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.com | |
| Contact Person | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | lkennedy@nephronpharm.com |
| Date Prepared | 31 May 2023 |
B. DEVICE IDENTIFICATION
| Name of the device | Nephron Nitrile Powder-Free Nitrile ExaminationGloves (Tested For Use With ChemotherapyDrugs and Fentanyl) |
|---|---|
| Product proprietary or trade name | Nephron Nitrile |
| Common or usual name | Nitrile Examination Gloves (Tested for use withChemotherapy drugs and Fentanyl) |
| 510(k) Number | K231349 |
| Classification name | 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) |
|---|---|
| 510(k) Number | K223559 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC, OPJ |
| Owner | Nephron Nitrile, LLC. |
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D. DESCRIPTION OF THE DEVICE:
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a 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). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) with sizes Medium, Large, X-Large and XX-Large are included in the submission.
E. INDICATION FOR USE OF THE DEVICE:
Nephron Nitrile Powder-Free Nitrile Examination 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 minutesThiotepa (10.0 mg/ml) : 128.1 minutesWarning: Not for Use with: Carmustine, Thiotepa | minutes |
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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 | --- | K223559 | K231349 | ||
| Name of device | --- | Nephron Nitrile Powder-Free Nitrile ExaminationGloves (Tested For UseWith Chemotherapy Drugs) | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested For Use WithChemotherapy Drugs andFentanyl) | Different:Except for theaddition ofFentanyl forsubject device,it is identical | |
| Product Code | --- | LZA, LZC, OPJ | LZA, LZC, OPJ, QDO | Different:Added oneproduct code | |
| Indication for use | --- | Nephron Nitrile Powder-Free Nitrile ExaminationGloves (Tested For UseWith Chemotherapy Drugs)is a disposable deviceintended for medicalpurpose that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 (2019) StandardPractice for Assessment ofResistance of MedicalGloves to Permeation byChemotherapy Drugs. | 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. | Different:Except for theaddition ofFentanyl forsubject device,it is identicalNote: Adding theFentanyl to theindicationdoes not affect theintended use. | |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical | |
| Material | --- | Nitrile | Nitrile | Identical | |
| Color | --- | Blue | Blue | Identical | |
| Size | --- | M, L, XL, XXL | M, L, XL, XXL | Identical | |
| Single Use | --- | Single-use | Single-use | Identical | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| PREDICATE | SUBJECT | ||||
| 510(K) Number | --- | K223559 | K231349 | ||
| Sterile/non sterile | --- | Non Sterile | Non Sterile | Identical | |
| Rx Only or OTC | --- | OTC | OTC | Identical | |
| Dimensions - Length | ASTMD6319-19 | Minimum 230 mm(sizes M - XXL) | Minimum 230 mm(sizes M - XXL) | Identical | |
| Dimensions - Width | ASTMD6319-19 | M: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | M: 95±10 mmL: 110±10 mmXL: 120±10 mmXXL: 130±10 mm | Identical | |
| Physical Properties-Tensile Strength | ASTMD63192019 | Before aging14MPa, min | Before aging14MPa, min | Identical | |
| After aging14MPa, min | After aging14MPa, min | Identical | |||
| Physical Properties-Ultimate Elongation | ASTMD63192019 | Before aging500%, min | Before aging500%, min | Identical | |
| After aging400%, min | After aging400%, min | Identical | |||
| Thickness | ASTMD6319-19 | Palm: Minimum 0.05 mmFinger: Minimum 0.05mm | 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 DrugsTested with MinimumBreakthrough DetectionTime | ASTM D6978-05 (2019) | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Identical | |
| Busulfan6 mg/ml (6,000 ppm)>240 Minutes | Busulfan6 mg/ml (6,000 ppm)>240 Minutes | Identical | |||
| Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | Identical | |||
| Carmustine3.3 mg/ml (3,300 ppm)33.8 Minutes | Carmustine3.3 mg/ml (3,300 ppm)33.8 Minutes | Identical | |||
| Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Identical | |||
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | PREDICATE | SUBJECT | Comparison | |
| 510(K) Number | --- | K223559 | K231349 | ||
| Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Identical | |||
| 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 | |||
| AS REQUIRED BY: 21CFR§807.92 | |||||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |||
| PREDICATE | SUBJECT | Comparison | |||
| 510(K) Number | --- | K223559 | K231349 | ||
| 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 | |||
| 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 | |||
| Rituximab10 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 (1,000 ppm)>240 Minutes | 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) | Not tested | Fentanyl Citrate Injection(100mcg/2mL) >240 Minutes | *Different | |
| 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: | 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 | ||
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | ||||
| PREDICATE | SUBJECT | Comparison | |||
| 510(K) Number | K223559 | K231349 | |||
| In vitrocytotoxicity-ISO 10993-5:Third Edition2009-06-01 | 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. | 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 mortality orevidence of systemic toxicity | Identical |
{6}------------------------------------------------
{7}------------------------------------------------
510(K) SUMMARY K231349
AS REQUIRED BY: 21CFR§807.92
{8}------------------------------------------------
510(K) SUMMARY K231349
Fourth Edition 2021-11
{9}------------------------------------------------
- Identical except for the addition of Fentany], which is the subject of this submission.
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 PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thelength of the gloves | Medium : 230 mm minLarge : 230 mm minX-Large : 230 mm minXX-Large : 230 mm min | Medium : 235 mmLarge : 237 mmX-Large : 250 mmXX-Large : 238 mm | |||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thewidth of the gloves | Medium : 95+/-10 mmLarge : 110+/-10 mmX-Large : 120+/-10 mmXX-Large : 130+/-10 mm | Medium : 95Large : 113X-Large : 121XX-Large : 129 | |||||||||||||||
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thethickness of thegloves | Palm: 0.05 mm minfor all sizesFinger: 0.05 mm minfor all sizes | Size Palm Finger 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 |
{10}------------------------------------------------
510(K) SUMMARY
K231349
AS REQUIRED BY: 21CFR§807.92
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | ||||||
|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa min for all sizesAfter AgeingTensile Strength14MPa min for all sizes | Size BeforeAgeing AfterAgeing Medium 34.0 MPa 37.3 MPa | ||||||
| To determine thephysical properties-UltimateElongation | Before AgeingUltimate Elongation500% min for all sizesAfter AgeingUltimate Elongation400% min for all sizes | Size BeforeAgeing AfterAgeing Medium 542% 503% | |||||||
| ASTM D5151-19 StandardTest Method for Detectionof Holes in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Pass AQL 2.5 | ||||||
| ASTM D6124-06(Reapproved 2017)StandardTest Method for ResidualPowder on Medical Gloves | To determine theresidual powder inthe gloves | ≤ 2 mg/glove | Medium: 0.3516 mg/glove |
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | 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 | ||
| 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 | ||
| AS REQUIRED BY: 21CFR§807.92 | |||
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
| (2,000 ppm) >240 Minutes | (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 | ||
| Gemcitabine 38 mg/ml(38,000 ppm) >240 Minutes | Gemcitabine 38 mg/ml(38,000 ppm) >240 Minutes | ||
| Idarubicin HCl 1 mg/ml(1,000 ppm) >240 Minutes | Idarubicin HCl 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Ifosfamide 50 mg/ml(50,000 ppm) >240 Minutes | Ifosfamide 50 mg/ml(50,000 ppm) >240 Minutes | ||
| Irinotecan 20 mg/ml(20,000 ppm) >240 Minutes | Irinotecan 20 mg/ml(20,000 ppm) >240 Minutes | ||
| Mechlorethamine HCl 1 mg/ml(1,000 ppm) >240 Minutes | Mechlorethamine HCl 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Melphalan 5 mg/ml(5,000 ppm) >240 Minutes | Melphalan 5 mg/ml(5,000 ppm) >240 Minutes | ||
| Methotrexate 25 mg/ml(25,000 ppm) >240 Minutes | Methotrexate 25 mg/ml(25,000 ppm) >240 Minutes | ||
| Mitomycin C 0.5 mg/ml(500 ppm) >240 Minutes | Mitomycin C 0.5 mg/ml(500 ppm) >240 Minutes | ||
| Mitoxantrone HCl 2 mg/ml(2,000 ppm) >240 Minutes | Mitoxantrone HCl 2 mg/ml(2,000 ppm) >240 Minutes | ||
| Paclitaxel 6 mg/ml(6,000 ppm) >240 Minutes | Paclitaxel 6 mg/ml(6,000 ppm) >240 Minutes | ||
| Rituximab 10 mg/ml(10,000 ppm) >240 Minutes | Rituximab 10 mg/ml(10,000 ppm) >240 Minutes | ||
| Trisenox 1 mg/ml(1,000 ppm) >240 Minutes | Trisenox 1 mg/ml(1,000 ppm) >240 Minutes | ||
| Vincristine Sulfate 1 mg/ml(1,000 ppm) >240 Minutes | Vincristine Sulfate 1 mg/ml(1,000 ppm) >240 Minutes | ||
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapy | To determine thebreakthroughdetection time ofOpioiddrugs | Fentanyl Citrate Injection(100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection(100mcg/2mL) >240 Minutes |
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510(K) SUMMARY
K231349
AS REQUIRED BY: 21CFR§807.92
{12}------------------------------------------------
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 First edition2021-01 BiologicalEvaluation of MedicalDevices - Part 23, Tests forIrritation. | To evaluate the localdermal irritation of atest article extractfollowingintracutaneousinjection in rabbits. | Under the condition of study not anirritant | Under the conditionsof the study, the testarticle met therequirements of thetest |
| 10993-10 Fourth edition2021-11 BiologicalEvaluation of MedicalDevices - Part 10, Tests forSkin Sensitization. | To evaluate the testitem, for the skinsensitization inGuinea pigs bymaximization test. | Under the conditions of the study,not a sensitizer | Under the conditionsof the study, the testarticle was notconsidered a sensitizer |
| ISO 10993-5 Third edition2009-06-01 BiologicalEvaluation of MedicalDevices - Part 5, Tests forIn Vitro Cytotoxicity. | To determine thepotential of a testarticle to causecytotoxicity | Under the conditions of the study,non-cytotoxic | The undiluted testarticle extract and 50%test article extractdilution did not meetthe requirements of thetest and the 25%.12.5%, 6.25%, and3.13% test articleextract dilutions metthe requirements of thetest. Cytotoxicityconcern was addressedby acute systemictoxicity testing. |
| ISO 10993-11 Thirdedition 2017-09 BiologicalEvaluation of MedicalDevices - Part 11, Tests forSystemic Toxicity. | To evaluate theacute systemictoxicity of a testarticle extractfollowinginjection in mice. | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern | Under the conditionsof study, there was nomortality or evidenceof systemic toxicity. |
The performance test data of the non-clinical tests meet following standards:
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.
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510(K) SUMMARY K231349
AS REQUIRED BY: 21CFR§807.92
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.
H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves.
CONCLUSION I.
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) K231349 submission, Nephron Nitrile Powder-Free Nitrile Examination 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 K223559.
§ 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.