(202 days)
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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 tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 26.3 minutes Thiotepa (10.0 mg/ml) : 49.1 minutes Warning: Not for Use with: Carmustine, Thiotepa
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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 black in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Medium, Large, X-Large and XX-Large.
The provided text describes the acceptance criteria and the results of a study for the "Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Characteristic) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Length | 220mm minimum for size XS and S; 230mm minimum for size M, L, XL and XXL | Pass |
| Width | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm; XXL: 130 ± 10 mm | Pass |
| Thickness (Palm & Finger) | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Pass |
| Tensile Strength (Before Ageing) | 14MPa min for all sizes | Pass |
| Tensile Strength (After Ageing) | 14MPa min for all sizes | Pass |
| Ultimate Elongation (Before Ageing) | 500% min for all sizes | Pass |
| Ultimate Elongation (After Ageing) | 400% min for all sizes | Pass |
| Freedom from Holes (ASTM D5151-19) | G-I, AQL 2.5 | Pass |
| Powder Free Residue (ASTM D6124-06) | ≤ 2 mg/glove | Pass |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | ||
| Bleomycin Sulfate (15 mg/ml) | >240 Minutes | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes |
| Carmustine (3.3 mg/ml) | 33.8 Minutes (Predicate) | 26.3 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes |
| Mechlorethamine HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes |
| Mitoxantrone HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes |
| Thiotepa (10 mg/ml) | 128.1 Minutes (Predicate) | 49.1 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes |
| Resistance to Permeation by Opioid Drugs (ASTM D6978-05) | ||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 Minutes | >240 Minutes |
| Biocompatibility (ISO 10993-23: Irritation) | Under the condition of study, not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| Biocompatibility (ISO 10993-10: Dermal Sensitization) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| Biocompatibility (ISO 10993-11: Acute Systemic Toxicity) | Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of acute systemic toxicity. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Bench Data" and "Biocompatibility Data" for the non-clinical tests. For these types of tests, specific sample sizes beyond what's typically required by the ASTM or ISO standards are not detailed in this summary. The data provenance is not specified, but these are standard laboratory tests. It is implied these are prospective tests conducted on the subject device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable (N/A). The device is a medical glove, and the evaluation relies on established standardized physical, chemical permeation, and biocompatibility tests, not subjective expert assessment of images or clinical outcomes that would require ground truth establishment by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments (e.g., in medical image interpretation). The tests performed are objective, standardized laboratory tests.
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 section is Not Applicable (N/A). This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is established by objective measurements against the specified ASTM and ISO standards. For instance:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly.
- Freedom from holes is determined by leakage tests per ASTM D5151-19.
- Powder residue is measured per ASTM D6124-06.
- Resistance to permeation by chemotherapy and opioid drugs is determined by measuring breakthrough time according to ASTM D6978-05.
- Biocompatibility is assessed through standardized biological tests (irritation, sensitization, systemic toxicity) as per ISO 10993 series.
8. The sample size for the training set
This section is Not Applicable (N/A). The device is a physical product (medical glove) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This section is Not Applicable (N/A), as it refers to a training set for machine learning, which is irrelevant for this medical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
March 20, 2024
Nephron Nitrile, LLC. Lou Kennedy Chief Executive Officer 4777 12th Street Extension West Columbia, South Carolina 29172
Re: K232654
Trade/Device Name: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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, ODO Dated: March 18, 2024 Received: March 18, 2024
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).
Sincerely,
Image /page/1/Picture/7 description: The image contains the text "Allan Guan -S". The text is written in a simple, sans-serif font and is horizontally aligned. The background of the image is plain white, with a faint watermark or design visible behind the text.
For Bifeng Qian, M.D., Ph.D. Assistant Director
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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) K232654
Device Name
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentany()
Indications for Use (Describe)
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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 tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 26.3 minutes Thiotepa (10.0 mg/ml) : 49.1 minutes Warning: Not for Use with: Carmustine, Thiotepa
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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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510(K) SUMMARY K232654 AS REQUIRED BY: 21CFR§807.92
A. APPLICANT INFORMATION
| 510(K) Owner's Name | Nephron Nitrile, LLC. |
|---|---|
| 510(K) Number | K232654 |
| Address | 4777 12th Street Extension, West Columbia, SC 29172. |
| Phone | 844-937-3888 |
| Fax | 1-803-926-9853 |
| NitrileRegulatory@nephronnitrile.com | |
| Contact Person #1 | Edmundo M. Garcia y Garcia |
| Designation | Vice President of Quality Operations |
| Contact Number | 1-803-908-5156 |
| Contact Email | NitrileRegulatory@nephronnitrile.com |
| Contact Person #2 | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | lkennedy@nephronpharm.com |
| Date Submitted | 18 March 2024 |
| Date Prepared | Revised 20 March 2024 |
B. DEVICE IDENTIFICATION
| Trade name of the device | Nephron Nitrile™, Nitrile Powder-Free ExaminationGloves Black (Tested For Use With ChemotherapyDrugs and Fentanyl) |
|---|---|
| Common or usual name | Nitrile Powder-Free Examination Gloves Black (TestedFor Use With Chemotherapy Drugs and Fentanyl) |
| 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 and Fentanyl) |
|---|---|
| 510(k) Number | K231349 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC, OPJ, QDO |
| Manufacturer | Nephron Nitrile, LLC. |
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510(K) SUMMARY K232654 AS REQUIRED BY: 21CFR §807.92 D. DESCRIPTION OF THE DEVICE:
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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 black in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Medium, Large, X-Large and XX-Large.
E. DEVICE MODIFICATIONS
The modification(s) within this 510(k) propose to revise the color additive, from a blue to black pigment. In addition to the color change, this 510(k) also intends to modify the available size range, to include size small and extra-small. All other aspects, including Intended Use, Indications for Use, and technological characteristics of the existing device remain unchanged.
F. INDICATION FOR USE OF THE DEVICE:
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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 to240 minutes: | The testedOpioid is: | ||
|---|---|---|---|
| Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) | FentanylCitrateInjection(100 mcg/2 mL)Permeation: nobreakthroughup to 240minutes |
| 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: | |||
| Carmustine (3.3 mg/ml) : 26.3 minutes | Thiotepa (10.0 mg/ml) : 49.1 minutes |
Warning: Not for Use with: Carmustine, Thiotepa
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510(K) SUMMARY K232654 AS REQUIRED BY: 21CFR§807.92
G. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE SUBJECT DEVICE AND PREDICATE DEVICE
| CHARACTERISTICSSTANDARDS | DEVICE PERFORMANCE | ||||
|---|---|---|---|---|---|
| PREDICATE | SUBJECT | Comparison | |||
| 510(K) Number | --- | K231349 | K232654 | ||
| Name of device | --- | Nephron Nitrile Powder-FreeNitrile Examination Gloves(Tested For Use WithChemotherapy Drugs andFentanyl) | Nephron Nitrile™, NitrilePowder-Free ExaminationGloves Black (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 ExaminationGloves Black (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 | Black | Different | |
| AS REQUIRED BY: 21CFR§807.92 | |||||
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | ||||
| PREDICATE | SUBJECT | Comparison | |||
| 510(K) Number | --- | K231349 | K232654 | ||
| safety orperformance. | |||||
| Similar | |||||
| Size | --- | M, L, XL, XXL | XS, S, M, L, XL, XXL | Adding sizeXS and S | |
| Single Use | --- | Single-use | Single-use | Identical | |
| Sterile/Non-sterile | --- | Non-Sterile | Non-Sterile | Identical | |
| Rx Only or OTC | --- | OTC | OTC | Identical | |
| Minimum 230 mm(sizes M - XXL) | Minimum 220 mm(Sizes XS-S)Minimum 230 mm(sizes M - XXL) | Similar | |||
| Dimensions - Length | ASTMD6319-19 | Adding sizeXS and S | |||
| 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 | Similar | |||
| Dimensions - Width | ASTMD6319-19 | Adding sizeXS and S | |||
| Before aging14MPa, min | Before aging14MPa, min | Identical | |||
| Physical Properties-Tensile Strength | ASTMD6319-19 | ||||
| After aging14MPa, min | After aging14MPa, min | Identical | |||
| Before aging500%, min | Before aging500%, min | Identical | |||
| Physical Properties-Ultimate Elongation | ASTMD6319-19 | ||||
| After aging400%, min | After aging400%, min | Identical | |||
| Palm: Minimum0.05 mmFinger: Minimum0.05 mm | Palm: Minimum0.05 mmFinger: Minimum0.05 mm | Identical | |||
| Thickness | ASTMD6319-19 | ||||
| ASTM D6319-19 | ≤ 2 mg per glove | ≤ 2 mg per glove | Identical | ||
| Powder Free Residue | |||||
| 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 | |||
| Freedom from holes | ASTM D5151-2019 | ||||
| Chemotherapy DrugsTested with MinimumBreakthrough Detection | ASTMD6978-05 (2019) | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Identical | |
| AS REQUIRED BY 21CFR807.92 | |||||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| 510(K) Number | --- | PREDICATE | SUBJECT | ||
| K231349 | K232654 | ||||
| Time | Busulfan | Busulfan | |||
| 6 mg/ml (6,000 ppm)>240 Minutes | 6 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)26.3 Minutes | Similar | |||
| Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Identical | |||
| 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 | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| 510(K) Number | PREDICATE | SUBJECT | |||
| 510(K) Number | --- | K231349 | K232654 | ||
| 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 | |||
| 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)49.1 Minutes | Similar | |||
| 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 | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| 510(K) Number | PREDICATE | SUBJECT | |||
| 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 | ||
| AcuteSystemicToxicity- ISO10993-11:Third Edition2017-09 | Under the conditions of thestudy, there was nomortality or evidence ofacute systemic toxicity | Under the conditions of thestudy, there was nomortality or evidence ofacute systemic toxicity | Identical |
{8}------------------------------------------------
{9}------------------------------------------------
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{11}------------------------------------------------
AS REQUIRED BY: 21CFR§807.92
The subject device in comparison to the predicate, is identical except for the change in color (from blue to black) and expansion of available glove sizes to include Small and Extra-Small, which is the subject of this submission.
H. SUMMARY OF NON-CLINICAL TESTING
BENCH DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULTS |
|---|---|---|---|
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thelength of thegloves | 220mm minimum for sizeXS and S230mm minimum for sizeM, L, XL and XXL | Pass |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thewidth of thegloves | XS: $70 \pm 10$ mmS: $80 \pm 10$ mmM: $95 \pm 10$ mmL: $110 \pm 10$ mmXL: $120 \pm 10$ mmXXL: $130 \pm 10$ mm | Pass |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Palm: 0.05 mm minfor all sizesFinger: 0.05 mm minfor all sizes | Pass |
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K232654
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULTS |
|---|---|---|---|
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysicalproperties-Tensile strength | Before AgeingTensile Strength14MPa min for all sizesAfter AgeingTensile Strength14MPa min for all sizes | Pass |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine thephysicalproperties-UltimateElongation | Before AgeingUltimate Elongation500% min for all sizesAfter AgeingUltimate Elongation400% min for all sizes | Pass |
| ASTM D5151-19StandardTest Method forDetectionof Holes in Medical | To determine theholes in the gloves | G-I, AQL 2.5 | Pass |
| ASTM D6124-06(Reapproved 2017)StandardTest Method for ResidualPowder on MedicalGloves | To determine theresidual powder inthe gloves | ≤ 2 mg/glove | Pass |
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULTS |
|---|---|---|---|
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of Resistanceof Medical Gloves toPermeation byChemotherapy Drugs. | To determine thebreakthroughdetection time ofchemotherapydrugs* | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes | Bleomycin Sulfate15 mg/ml (15,000 ppm)>240 Minutes |
| Busulfan6 mg/ml (6,000 ppm)>240 Minutes | Busulfan6 mg/ml (6,000 ppm)>240 Minutes | ||
| Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | Carboplatin10 mg/ml (10,000 ppm)>240 Minutes | ||
| Carmustine3.3 mg/ml (3,300 ppm)33.8 Minutes | Carmustine3.3 mg/ml (3,300 ppm)26.3 Minutes | ||
| Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | Cisplatin1 mg/ml (1,000 ppm)>240 Minutes | ||
| Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | Cyclophosphamide20 mg/ml (20,000 ppm)>240 Minutes | ||
| Cytarabine100 mg/ml (100,000 ppm)>240 Minutes | Cytarabine100 mg/ml (100,000 ppm)>240 Minutes | ||
| Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | Dacarbazine10 mg/ml (10,000 ppm)>240 Minutes | ||
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULTS |
| Daunorubicin HCl5 mg/ml (5,000 ppm)>240 Minutes | Daunorubicin HCl5 mg/ml (5,000 ppm)>240 Minutes | ||
| Docetaxel10 mg/ml (10,000 ppm)>240 Minutes | Docetaxel10 mg/ml (10,000 ppm)>240 Minutes | ||
| Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Doxorubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | ||
| Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | Epirubicin HCl2 mg/ml (2,000 ppm)>240 Minutes | ||
| Etoposide20 mg/ml (20,000 ppm)>240 Minutes | Etoposide20 mg/ml (20,000 ppm)>240 Minutes | ||
| Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | Fludarabine25 mg/ml (25,000 ppm)>240 Minutes | ||
| Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | Fluorouracil50 mg/ml (50,000 ppm)>240 Minutes | ||
| Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | Gemcitabine38 mg/ml (38,000 ppm)>240 Minutes | ||
| Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | Idarubicin HCl1 mg/ml (1,000 ppm)>240 Minutes | ||
| Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | Ifosfamide50 mg/ml (50,000 ppm)>240 Minutes | ||
| Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | Irinotecan20 mg/ml (20,000 ppm)>240 Minutes | ||
| Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | Mechlorethamine HCl1 mg/ml (1,000 ppm)>240 Minutes | ||
| Melphalan5 mg/ml (5,000 ppm)>240 Minutes | Melphalan5 mg/ml (5,000 ppm)>240 Minutes | ||
| Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | Methotrexate25 mg/ml (25,000 ppm)>240 Minutes | ||
| Mitomycin C0.5 mg/ml (500 ppm)>240 Minutes | Mitomycin C0.5 mg/ml (500 ppm)>240 Minutes | ||
| Mitoxantrone HCl2 mg/ml (2,000 ppm)>240 Minutes | Mitoxantrone HCl2 mg/ml (2,000 ppm)>240 Minutes | ||
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULTS |
| ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of Resistanceof Medical Gloves toPermeation byChemotherapy Drugs. | To determine thebreakthroughdetection time ofOpioid drugs | 6 mg/ml (6,000 ppm)>240 Minutes | 6 mg/ml (6,000 ppm)>240 Minutes |
| Rituximab 10 mg/ml(10,000 ppm)>240 Minutes | Rituximab 10mg/ml (10,000 ppm)>240 Minutes | ||
| Thiotepa10 mg/ml (10,000 ppm)128.1 Minutes | Thiotepa10 mg/ml (10,000 ppm)49.1 Minutes | ||
| Trisenox1 mg/ml (1,000ppm) >240Minutes | Trisenox1 mg/ml (1,000ppm) >240Minutes | ||
| Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | Vincristine Sulfate1 mg/ml (1,000 ppm)>240 Minutes | ||
| Fentanyl Citrate Injection(100mcg/2mL)>240 Minutes | Fentanyl Citrate Injection(100mcg/2mL)>240 Minutes |
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K232654
{14}------------------------------------------------
K232654
AS REQUIRED BY: 21CFR§807.92
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULTS |
|---|---|---|---|
| ISO 10993-23 Firstedition 2021-01Biological Evaluation ofMedical Devices - Part23, Tests for Irritation. | To evaluate thelocal dermalirritation of a testarticle extractfollowingintracutaneousinjection inrabbits. | Under the condition of studynot 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, Testsfor Skin Sensitization. | To evaluate thetest item, for theskin sensitizationin Guinea pigs bymaximization test. | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, the test article was notconsidered a sensitizer |
| ISO 10993-11 Thirdedition 2017-09Biological Evaluation ofMedical Devices - Part11, Tests for SystemicToxicity. | To evaluate theacute systemictoxicity of a testarticle extractfollowing injectionin mice. | Under the conditions ofstudy, the device extracts donot pose an acute systemictoxicity concern | Under the conditions ofstudy, there was nomortality or evidence ofacute systemic toxicity. |
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510(K) SUMMARY K232654 AS REQUIRED BY: 21CFR §807.92
The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
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.
- . 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 10993-11 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.
I. CONCLUSION
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (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.