Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

K223559 · Nephron Pharmaceuticals Corporation · LZA · Feb 9, 2023 · General Hospital

Device Facts

• Record ID: K223559
• Device Name: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
• Applicant: Nephron Pharmaceuticals Corporation
• Product Code: LZA · General Hospital
• Decision Date: Feb 9, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) 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 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 nitrile examination gloves; fingertip textured with beaded cuff. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05 (2019). Provides barrier protection; healthcare providers use gloves during patient examinations and handling of chemotherapy agents. Benefits include reduced risk of contamination and protection against specific hazardous drug exposure.

Clinical Evidence

No clinical data; bench testing only. Performance verified via ASTM standards for physical properties (tensile strength, elongation), barrier integrity (freedom from holes), residual powder, and chemotherapy drug permeation resistance.

Technological Characteristics

Material: Nitrile (NBR). Form: Blue, powder-free, fingertip textured, beaded cuff, ambidextrous. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-5, -10, -11, -23.

Indications for Use

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

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

• Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440)

Reference Devices

• SHOWA® Blue Nitrile Powder Free Medical Examination Glove (K211003)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 9, 2023

Nephron Pharmaceuticals Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

### Re: K223559

Trade/Device Name: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: February 1, 2023 Received: February 1, 2023

Dear Prithul Bom:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Allan Gu

For Bifeng Oian, 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) K223559

#### Device Name

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

#### Indications for Use (Describe)

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) 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 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: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

| 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 K223559 AS REQUIRED BY: 21CFR§807.92

### A. APPLICANT INFORMATION

| 510(K) Owner's Name | Nephron Pharmaceuticals Corporation |
|---------------------|---------------------------------------------------------|
| Address | 4500 12th Street Extension, West Columbia, SC<br>29172. |
| Phone | 1-803-569-3110 |
| Fax | 1-803-926-9853 |
| E-mail | [e-mail] |
| Contact Person | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | [e-mail] |
| Date Submitted | 21 October 2022 |

### B. DEVICE IDENTIFICATION

| Name of the device | Nephron Nitrile Powder-Free Nitrile Examination<br>Gloves (Tested For Use With Chemotherapy<br>Drugs) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | Nephron Nitrile |
| Common or usual name | Nitrile Examination Gloves (Tested for use with<br>Chemotherapy drugs) |
| Classification name | Non-Powdered Patient Examination Glove Specialty |
| Device Classification | Class-1, Reserved |
| Product Code | LZA, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital and Personal Use Devices |

### C. PREDICATE DEVICE

| Predicate Device | Powder Free Nitrile Examination Gloves (Blue,<br>Purple-Blue), Tested for Use with Chemotherapy<br>Drugs |
|------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213440 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC |

| Reference Device | SHOWA® Blue Nitrile Powder Free Medical<br>Examination Glove |
|------------------|--------------------------------------------------------------|
| 510(k) Number | K211003 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC |

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### D. DESCRIPTION OF THE DEVICE:

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). 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) 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) 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 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: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

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### F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison |
|--------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | PREDICATE | REFERENCE | SUBJECT | |
| 510(K) Number | --- | K213440 | K211003 | K223559 | |
| Name of device | --- | Powder Free<br>Nitrile<br>Examination<br>Gloves (Blue,<br>Purple-Blue),<br>Tested for Use with<br>Chemotherapy<br>Drugs | SHOWA® Blue<br>Nitrile Powder Free<br>Medical Examination<br>Glove | Nephron Nitrile<br>Powder-Free Nitrile<br>Examination Gloves<br>(Tested For Use With<br>Chemotherapy Drugs) | Similar<br>to<br>predicate<br>device |
| Product Code | --- | LZA, LZC | LZA, LZC | LZA, LZC, OPJ | Similar |
| Indication for use | --- | Powder Free<br>Nitrile<br>Examination<br>Gloves (Blue,<br>Purple-Blue),<br>Tested for Use with<br>Chemotherapy<br>Drugs is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient<br>and examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hands or<br>fingers to prevent<br>contamination<br>between patient and<br>examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with<br>ASTM D6978-05<br>Standard Practice for<br>Assessment of<br>Medical Glove to<br>Permeation by<br>chemotherapy drugs. | Nephron Nitrile<br>Powder-Free Nitrile<br>Examination Gloves<br>(Tested For Use With<br>Chemotherapy Drugs)<br>is a disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. In addition,<br>these gloves were<br>tested for use with<br>chemotherapy drugs<br>in accordance with<br>ASTM D6978-05<br>(2019) Standard<br>Practice for<br>Assessment of<br>Resistance of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs. | Similar |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | --- | Nitrile | Nitrile | Nitrile | Same |
| Color | --- | Blue, Purple-Blue | Blue | Blue | Same |
| Size | --- | XS, S, M, L, XL | XS, S, M, L, XL | M, L, XL, XXL | Similar |

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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | | | | | | | | | | | | |
|------------------------------------------|-----------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | PREDICATE | REFERENCE | SUBJECT | | | | | | | | | | | | | | | | |
| 510(K) Number | --- | K213440 | K211003 | K223559 | | | | | | | | | | | | | | | | |
| Single Use | --- | Single-use | Single-use | Single-use | Same | | | | | | | | | | | | | | | |
| Sterile/non sterile | --- | Non Sterile | Non Sterile | Non Sterile | Same | | | | | | | | | | | | | | | |
| Rx Only or OTC | --- | OTC | OTC | OTC | Same | | | | | | | | | | | | | | | |
| Dimensions - Length | ASTM D6319-19 | Minimum 230mm | Overall Length (mm) = 220 mm (sizes XS – S) and 230 mm (sizes M – XL) | Minimum 230 mm | Similar | | | | | | | | | | | | | | | |
| | | | | Size Average value M 235 L 237 XL 250 XXL 238 | | | | | | | | | | | | | | | | |
| Dimensions - Width | ASTM D6319-19 | XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10<br>XXL: 130±10 | Width (± 10 mm)<br>Size XS = 70 mm<br>Size S = 80 mm<br>Size M = 95 mm<br>Size L = 110 mm<br>Size XL = 120 mm | M: 95±10 mm<br>L: 110±10 mm<br>XL: 120±10 mm<br>XXL: 130±10 mm | Same | | | | | | | | | | | | | | | |
| | | | | Size Average value M 95 L 113 XL 121 XXL 129 | | | | | | | | | | | | | | | | |
| Physical Properties- Tensile Strength | ASTM D6319-2019 | Before aging 14MPa, min | Before aging (MPa) = 14 min | Before aging 14MPa, min<br>Average value = 34.0 MPa (Medium) | Same | | | | | | | | | | | | | | | |
| | | After aging 14MPa, min | After aging (MPa) = 14 min | After aging 14MPa, min<br>Average value = 37.3 MPa (Medium) | Same | | | | | | | | | | | | | | | |
| Physical Properties- Ultimate Elongation | ASTM D6319-2019 | Before aging 500%, min | Before aging (%) = 500 min | Before aging 500%, min<br>Average value = 542% (Medium) | Same | | | | | | | | | | | | | | | |
| | | After aging 400%, min | After aging (%) = 400 min | After aging 400%, min<br>Average value = 503% (Medium) | Same | | | | | | | | | | | | | | | |
| Thickness | ASTM D6319-19 | Palm: Minimum 0.05 mm<br>Finger: Minimum 0.05 mm | Palm (mm) = 0.05 min<br>Finger Tip (mm) = 0.05 min | Palm: Minimum 0.05 mm<br>Finger: Minimum 0.05 mm | Same | | | | | | | | | | | | | | | |
| | | | | Size Palm (Avg value) Finger (Avg value) M 0.077 0.111 L 0.106 0.109 XL 0.089 0.115 XXL 0.113 0.107 | | | | | | | | | | | | | | | | |

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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | | PREDICATE | REFERENCE | SUBJECT | | |
| 510(K) Number | | K213440 | K211003 | | | |
| Powder Free Residue | ASTM<br>D6319-19 | ≤ 2 mg per glove | ≤ 2.0 mg/pc | ≤2 mg per glove<br>Average value = 0.3516<br>mg/glove (Medium) | Same | |
| Freedom from holes | ASTM D5151-<br>2019 | In accordance with<br>ASTM D 5151-19,<br>following ASTM<br>D6319-19,<br>G-I, AQL 2.5 | AQL 2.5<br>Inspection Level<br>G-1 | In accordance with<br>ASTM D 5151-19,<br>following ASTM<br>D6319-19,<br>G-I, AQL 2.5 | Same | |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough<br>Detection Time | ASTM D6978-<br>05 (2019) | Bleomycin Sulfate<br>15 mg/ml (15,000 ppm)<br>>240 Minutes | Blenoxane<br>(15.0 mg/ml)<br>>240 Minutes | Bleomycin Sulfate<br>15 mg/ml (15,000 ppm)<br>>240 Minutes | Same | |
| | | Busulfan<br>6 mg/ml (6,000 ppm)<br>>240 Minutes | Busulfan<br>(6.0 mg/ml)<br>>240 Minutes | Busulfan<br>6 mg/ml (6,000 ppm)<br>>240 Minutes | Same | |
| | | Carboplatin<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Carboplatin<br>(10.0 mg/ml)<br>>240 Minutes | Carboplatin<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Same | |
| | | Carmustine<br>3.3 mg/ml (3,300 ppm)<br>25.5 Minutes | Carmustine<br>(3.3 mg/ml)<br>73.7 Minutes | Carmustine<br>3.3 mg/ml (3,300 ppm)<br>33.8 Minutes | Similar | |
| | | Chloroquine<br>50mg/ml (50,000ppm)<br>>240 Minutes | --- | Not tested | Optional* | |
| | | Cisplatin<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Cisplatin<br>(1.0 mg/ml)<br>>240 Minutes | Cisplatin<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Same | |
| | | Cyclophosphamide<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Cyclophosphamide<br>(20.0 mg/ml)<br>>240 Minutes | Cyclophosphamide<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Same | |
| | | Cyclosporin<br>100 mg/ml (100,000 ppm)<br>>240 Minutes | --- | Not tested | Optional* | |
| | | Cytarabine HCL<br>100 mg/ml (100,000 ppm)<br>>240 Minutes | --- | Not tested | Optional* | |
| | | | Cytarabine<br>(100.0 mg/ml)<br>>240 Minutes | Cytarabine<br>100 mg/ml (100,000 ppm)<br>>240 Minutes | Same as<br>reference<br>device | |
| | | Dacarbazine<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Dacarbazine<br>(10.0 mg/ml)<br>>240 Minutes | Dacarbazine<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | |
| 510(K) Number | | PREDICATE | REFERENCE | SUBJECT | | |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough Detection<br>Time | ASTM<br>D6978-05<br>(2019) | Daunorubicin HCL<br>5 mg/ml (5,000 ppm)<br>>240 Minutes | Daunorubicin HCl<br>(5.0 mg/ml)<br>>240 Minutes | Daunorubicin HCl<br>5 mg/ml (5,000 ppm)<br>>240 Minutes | Same | |
| | | Docetaxel HCL<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | --- | Not tested | Optional* | |
| | | | Docetaxel<br>(10.0 mg/ml)<br>>240 Minutes | Docetaxel<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Same as<br>reference<br>device | |
| | | Doxorubicin HCl<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | Doxorubicin HCl<br>(2.0 mg/ml)<br>>240 Minutes | Doxorubicin HCl<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | Same | |
| | | Epirubicin HCl<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | Epirubicin HCl (2.0<br>mg/ml)<br>>240 Minutes | Epirubicin HCl<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | Same | |
| | | Etoposide<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Etoposide<br>(20.0 mg/ml)<br>>240 Minutes | Etoposide<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Same | |
| | | Fludarabine<br>25 mg/ml (25,000 ppm)<br>>240 Minutes | Fludarabine<br>(25.0 mg/ml)<br>>240 Minutes | Fludarabine<br>25 mg/ml (25,000 ppm)<br>>240 Minutes | Same | |
| | | Fluorouracil<br>50 mg/ml (50,000 ppm)<br>>240 Minutes | Fluorouracil<br>(50.0 mg/ml)<br>>240 Minutes | Fluorouracil<br>50 mg/ml (50,000 ppm)<br>>240 Minutes | Same | |
| | | Gemcitabine<br>38 mg/ml (38,000 ppm)<br>>240 Minutes | Gemcitabine<br>(38.0 mg/ml)<br>>240 Minutes | Gemcitabine<br>38 mg/ml (38,000 ppm)<br>>240 Minutes | Same | |
| | | Idarubicin HCl<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Idarubicin HCl (1.0<br>mg/ml)<br>>240 Minutes | Idarubicin HCl<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Same | |
| | | Ifosfamide<br>50 mg/ml (50,000 ppm)<br>>240 Minutes | Ifosfamide<br>(50.0 mg/ml)<br>>240 Minutes | Ifosfamide<br>50 mg/ml (50,000 ppm)<br>>240 Minutes | Same | |
| | | Irinotecan<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Irinotecan<br>(20.0 mg/ml)<br>>240 Minutes | Irinotecan<br>20 mg/ml (20,000 ppm)<br>>240 Minutes | Same | |
| | | Mechlorethamine HCl<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Mechlorethamine<br>HCl (1.0 mg/ml)<br>>240 Minutes | Mechlorethamine HCl<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Same | |
| | | Melphalan<br>5 mg/ml (5,000 ppm)<br>>240 Minutes | Melphalan<br>(5.0 mg/ml)<br>>240 Minutes | Melphalan<br>5 mg/ml (5,000 ppm)<br>>240 Minutes | Same | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | |
| | | PREDICATE | REFERENCE | SUBJECT | | |
| 510(K) Number | | K213440 | K211003 | | | |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough<br>Detection Time | ASTM<br>D6978-05<br>(2019) | Methotrexate<br>25 mg/ml (25,000 ppm)<br>>240 Minutes | Methotrexate<br>(25.0 mg/ml)<br>>240 Minutes | Methotrexate<br>25 mg/ml (25,000 ppm)<br>>240 Minutes | Same | |
| | | Mitomycin<br>0.5 mg/ml (500 ppm)<br>>240 Minutes | Mitomycin C<br>(0.5 mg/ml)<br>>240 Minutes | Mitomycin C<br>0.5 mg/ml (500 ppm)<br>>240 Minutes | Same | |
| | | Mitoxantrone HCL<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | | Mitoxantrone HCl<br>2 mg/ml (2,000 ppm)<br>>240 Minutes | Same as<br>predicate<br>device | |
| | | | Mitoxantrone<br>(2.0 mg/ml)<br>>240 Minutes | Not tested | Optional* | |
| | | Oxaliplatin<br>5mg/ml (5,000ppm)<br>>240 Minutes | | Not tested | Optional* | |
| | | Paclitaxel<br>6 mg/ml (6,000 ppm)<br>>240 Minutes | Paclitaxel<br>(6.0 mg/ml)<br>>240 Minutes | Paclitaxel<br>6 mg/ml (6,000 ppm)<br>>240 Minutes | Same | |
| | | Paraplatin/Carboplatin,<br>10mg/ml (10,000ppm)<br>>240 Minutes | | Not tested | Optional* | |
| | | Retrovir<br>10mg/ml (10,000ppm)<br>>240 Minutes | | Not tested | Optional* | |
| | | Rituximab<br>10mg/ml (10,000 ppm)<br>>240 Minutes | Rituximab<br>(10.0 mg/ml)<br>>240 Minutes | Rituximab<br>10 mg/ml (10,000 ppm)<br>>240 Minutes | Same | |
| | | Thiotepa<br>10mg/ml (10,000 ppm)<br>66.8 Minutes | ThioTepa<br>(10.0 mg/ml)<br>25.4 Minutes | Thiotepa<br>10 mg/ml (10,000 ppm)<br>128.1 Minutes | Similar | |
| | | Topotecan<br>1mg/ml (1,000ppm)<br>>240 Minutes | | Not tested | Optional* | |
| | | Trisenox<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Trisenox<br>(1.0 mg/ml)<br>>240 Minutes | Trisenox<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Same | |
| | | Velcade (Bortezomib)<br>1mg/ml (1,000ppm)<br>>240 Minutes | | Not tested | Optional* | |
| | | Vincristine Sulfate<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Vincristine Sulfate<br>(1.0 mg/ml)<br>>240 Minutes | Vincristine Sulfate<br>1 mg/ml (1,000 ppm)<br>>240 Minutes | Same | |
| CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | | | Comparison | |
| | | PREDICATE | REFERENCE | SUBJECT | | |
| 510(K) Number | --- | K213440 | K211003 | K223559 | | |
| Biocompatibility | Primary Skin<br>Irritation- ISO<br>10993-23: First<br>Edition 2021-<br>01 | Under the conditions of<br>the study, not an irritant | Under the<br>conditions of the<br>study, not a<br>primary skin<br>irritant. | Under the conditions of<br>the study, the test article<br>met the requirements of<br>the test | Same | |
| | | Dermal<br>Sensitization-<br>ISO 10993-10:<br>Fourth Edition<br>2021-11 | Under the conditions of<br>the study, not a sensitizer | Under conditions<br>of the study, not a<br>contact sensitizer | Under the conditions of<br>the study, the test article<br>was not considered a<br>sensitizer | Same |
| | | In vitro<br>cytotoxicity-<br>ISO 10993-5:<br>Third Edition<br>2009-06-01 | Under the conditions of<br>this study, the test article<br>extract showed potential<br>toxicity | --- | Under the conditions of<br>the study, the undiluted<br>test article extract and<br>50% test article extract<br>dilution did not meet the<br>requirements of the test<br>and the 25%, 12.5%,<br>6.25%, and 3.13% test<br>article extract dilutions<br>met the requirements of<br>the test | Similar to<br>predicate<br>device |
| | | Acute<br>Systemic<br>Toxicity- ISO<br>10993-11:<br>Third Edition<br>2017-09 | Under the conditions of<br>this study, there was no<br>evidence of systemic<br>toxicity. | Under conditions<br>of the ISO Acute<br>Systemic Injection<br>test, not toxic | Under the conditions of<br>the study, there was no<br>mortality or evidence of<br>systemic toxicity…