Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)

K232654 · Nephron Nitrile, LLC · LZA · Mar 20, 2024 · General Hospital

Device Facts

• Record ID: K232654
• Device Name: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
• Applicant: Nephron Nitrile, LLC
• Product Code: LZA · General Hospital
• Decision Date: Mar 20, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Disposable, non-sterile, ambidextrous, powder-free nitrile examination gloves; black color; fingertip textured; beaded cuff. Used by healthcare professionals in clinical settings to prevent cross-contamination between patient and examiner. Provides barrier protection against biological contaminants and specific chemotherapy drugs and fentanyl. Input: physical barrier requirement. Output: physical protection. Benefit: reduces risk of contamination and exposure to hazardous drugs during medical examinations.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Nitrile (NBR) latex. Form factor: Ambidextrous, beaded cuff, fingertip textured. Sizes: XS, S, M, L, XL, XXL. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ISO 10993-11 (systemic toxicity). Non-sterile, single-use.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and fentanyl.

Regulatory Classification

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.

Predicate Devices

• Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 |
| E-mail | [e-mail] |
| Contact Person #1 | Edmundo M. Garcia y Garcia |
| Designation | Vice President of Quality Operations |
| Contact Number | 1-803-908-5156 |
| Contact Email | [e-mail] |
| Contact Person #2 | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | [e-mail] |
| Date Submitted | 18 March 2024 |
| Date Prepared | Revised 20 March 2024 |

### B. DEVICE IDENTIFICATION

| Trade name of the device | Nephron Nitrile™, Nitrile Powder-Free Examination<br>Gloves Black (Tested For Use With Chemotherapy<br>Drugs and Fentanyl) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common or usual name | Nitrile Powder-Free Examination Gloves Black (Tested<br>For 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 Examination<br>Gloves (Tested For Use With Chemotherapy<br>Drugs 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 to<br>240 minutes: | | | The tested<br>Opioid is: |
|-------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) | Fentanyl<br>Citrate<br>Injection<br>(100 mcg/2 mL)<br><br>Permeation: no<br>breakthrough<br>up to 240<br>minutes |
| 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

| | CHARACTERISTICS<br>STANDARDS | DEVICE PERFORMANCE | | | |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------|
| | | PREDICATE | SUBJECT | Comparison | |
| 510(K) Number | --- | K231349 | K232654 | | |
| Name of device | --- | Nephron Nitrile Powder-Free<br>Nitrile Examination Gloves<br>(Tested For Use With<br>Chemotherapy Drugs and<br>Fentanyl) | Nephron Nitrile™, Nitrile<br>Powder-Free Examination<br>Gloves Black (Tested For Use<br>With Chemotherapy Drugs<br>and Fentanyl) | Similar | |
| Product Code | --- | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Identical | |
| Indication for use | --- | Nephron Nitrile Powder-Free<br>Nitrile Examination Gloves<br>(Tested For Use With<br>Chemotherapy Drugs and<br>Fentanyl) is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs and<br>fentanyl in accordance with<br>ASTM D6978-05 (2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | Nephron Nitrile™, Nitrile<br>Powder-Free Examination<br>Gloves Black (Tested For Use<br>With Chemotherapy Drugs<br>and Fentanyl) is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs and<br>fentanyl in accordance with<br>ASTM D6978-05 (2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy 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 or<br>performance. | |
| | | | | Similar | |
| Size | --- | M, L, XL, XXL | XS, S, M, L, XL, XXL | Adding size<br>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 | |
| | | Minimum 230 mm<br>(sizes M - XXL) | Minimum 220 mm<br>(Sizes XS-S)<br>Minimum 230 mm<br>(sizes M - XXL) | Similar | |
| Dimensions - Length | ASTM<br>D6319-19 | | | Adding size<br>XS and S | |
| | | M: 95±10 mm<br>L: 110±10 mm<br>XL: 120±10 mm<br>XXL: 130±10 mm | XS: 70±10 mm<br>S: 80±10 mm<br>M: 95±10 mm<br>L: 110±10 mm<br>XL: 120±10 mm<br>XXL: 130±10 mm | Similar | |
| Dimensions - Width | ASTM<br>D6319-19 | | | Adding size<br>XS and S | |
| | | Before aging<br>14MPa, min | Before aging<br>14MPa, min | Identical | |
| Physical Properties-<br>Tensile Strength | ASTM<br>D6319-19 | | | | |
| | | After aging<br>14MPa, min | After aging<br>14MPa, min | Identical | |
| | | Before aging<br>500%, min | Before aging<br>500%, min | Identical | |
| Physical Properties-<br>Ultimate Elongation | ASTM<br>D6319-19 | | | | |
| | | After aging<br>400%, min | After aging<br>400%, min | Identical | |
| | | Palm: Minimum<br>0.05 mm<br>Finger: Minimum<br>0.05 mm | Palm: Minimum<br>0.05 mm<br>Finger: Minimum<br>0.05 mm | Identical | |
| Thickness | ASTM<br>D6319-19 | | | | |
| | ASTM D6319-<br>19 | ≤ 2 mg per glove | ≤ 2 mg per glove | Identical | |
| Powder Free Residue | | | | | |
| | | In accordance with<br>ASTM D 5151-19,<br>following ASTM D6319- 19,<br>G-I, AQL 2.5 | In accordance with<br>ASTM D 5151-19,<br>following ASTM D6319- 19,<br>G-I, AQL 2.5 | Identical | |
| Freedom from holes | ASTM D5151-<br>2019 | | | | |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough Detection | ASTM<br>D6978-<br>05 (2019) | Bleomycin Sulfate<br>15 mg/ml (15,000 ppm)<br>>240 Minutes | Bleomycin Sulfate<br>15 mg/ml (15,000 ppm)<br>>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)<br>>240 Minutes | 6 mg/ml (6,000 ppm)<br>>240 Minutes | Identical |
| | | | Carboplatin<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Carboplatin<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Identical |
| | | | Carmustine<br>3.3 mg/ml (3,300 ppm)<br>33.8 Minutes | Carmustine<br>3.3 mg/ml (3,300 ppm)<br>26.3 Minutes | Similar |
| | | | Cisplatin<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Cisplatin<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Identical |
| | | | Cyclophosphamide<br>20 mg/ml (20,000 ppm)<br>>240 Minutes…