Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the description focuses on its material properties and resistance to chemicals, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is described as examination gloves intended to prevent contamination between the patient and examiner, not to provide therapy or treat a condition.

Diagnostic

No

Explanation: The device is described as "a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This indicates its role as a barrier for protection, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, not a software program. The description details material, physical characteristics, and testing against chemical permeation, all related to a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
Device Description: The device is described as "Class I patient examination gloves," which are regulated under a different section of the CFR (21 CFR 880.6250) than IVDs.
Performance Studies: The performance studies focus on the physical properties of the gloves (strength, integrity, resistance to chemicals) and biocompatibility, not on diagnostic accuracy or performance related to analyzing biological samples.

The testing for chemotherapy drugs and fentanyl resistance is related to the protective function of the gloves, not to diagnosing or testing for these substances in a patient sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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."

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ, QDO

Device Description

"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."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Examiner's hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device underwent non-clinical bench testing to demonstrate substantial equivalence. The tests performed include:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the length, width, thickness, physical properties (tensile strength and ultimate elongation) of the gloves. All tests passed.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical: To determine the holes in the gloves. Result: Pass (G-I, AQL 2.5).
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: To determine the residual powder in the gloves. Result: Pass (≤ 2 mg/glove).
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: To determine the breakthrough detection time of chemotherapy drugs and opioid drugs. Most chemotherapy drugs tested showed no breakthrough up to 240 minutes. Carmustine showed a breakthrough time of 26.3 minutes and Thiotepa showed 49.1 minutes. Fentanyl Citrate Injection showed no breakthrough up to 240 minutes.
Biocompatibility testing as per ISO standards:
- ISO 10993-23 First edition 2021-01 (Tests for Irritation): To evaluate local dermal irritation in rabbits. Results met requirements.
- ISO 10993-10 Fourth edition 2021-11 (Tests for Skin Sensitization): To evaluate skin sensitization in Guinea pigs by maximization test. Not considered a sensitizer.
- ISO 10993-11 Third edition 2017-09 (Tests for Systemic Toxicity): To evaluate acute systemic toxicity in mice. No mortality or evidence of acute systemic toxicity.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics reported from bench testing:

Length: 220mm minimum for size XS and S; 230mm minimum for size M, L, XL and XXL.
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.
Thickness: Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes.
Tensile Strength: Before Ageing: 14MPa min for all sizes; After Ageing: 14MPa min for all sizes.
Ultimate Elongation: Before Ageing: 500% min for all sizes; After Ageing: 400% min for all sizes.
Freedom from holes: G-I, AQL 2.5.
Residual Powder: ≤ 2 mg/glove.

Chemotherapy drug permeation times (no breakthrough detected up to 240 minutes for all listed, except noted below):

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)

Low permeation times:

Carmustine (3.3 mg/ml): 26.3 minutes
Thiotepa (10.0 mg/ml): 49.1 minutes

Opioid permeation time:

Fentanyl Citrate Injection (100 mcg/2 mL): no breakthrough up to 240 minutes

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K231349

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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.

1

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

2

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

3

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

4

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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5

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	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 Examination
Gloves Black (Tested For Use With Chemotherapy
Drugs and Fentanyl) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common or usual name | Nitrile Powder-Free Examination Gloves Black (Tested
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
Gloves (Tested For Use With Chemotherapy
Drugs and Fentanyl) |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231349 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC, OPJ, QDO |
| Manufacturer | Nephron Nitrile, LLC. |

6

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
240 minutes: | | | The tested
Opioid is: |
|-------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Bleomycin Sulfate (15.0 mg/ml) | Doxorubicin HCl (2.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) | Fentanyl
Citrate
Injection
(100 mcg/2 mL)

Warning: Not for Use with: Carmustine, Thiotepa

7

510(K) SUMMARY K232654 AS REQUIRED BY: 21CFR§807.92

G. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE SUBJECT DEVICE AND PREDICATE DEVICE

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

240 Minutes | Bleomycin Sulfate
15 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 |
| | | | Carboplatin
10 mg/ml (10,000 ppm)
240 Minutes | Carboplatin
10 mg/ml (10,000 ppm)
240 Minutes | Identical |
| | | | Carmustine
3.3 mg/ml (3,300 ppm)
33.8 Minutes | Carmustine
3.3 mg/ml (3,300 ppm)
26.3 Minutes | Similar |
| | | | Cisplatin
1 mg/ml (1,000 ppm)
240 Minutes | Cisplatin
1 mg/ml (1,000 ppm)
240 Minutes | Identical |
| | | | Cyclophosphamide
20 mg/ml (20,000 ppm)
240 Minutes | Cyclophosphamide
20 mg/ml (20,000 ppm)
240 Minutes | Identical |
| | | | Cytarabine
100 mg/ml (100,000 ppm)
240 Minutes | Cytarabine
100 mg/ml (100,000 ppm)
240 Minutes | Identical |
| | | | Dacarbazine
10 mg/ml (10,000 ppm)
240 Minutes | Dacarbazine
10 mg/ml (10,000 ppm)
240 Minutes | Identical |
| | | | Daunorubicin HCl
5 mg/ml (5,000 ppm)
240 Minutes | Daunorubicin HCl
5 mg/ml (5,000 ppm)
240 Minutes | Identical |
| | | | Docetaxel
10 mg/ml (10,000 ppm)
240 Minutes | Docetaxel
10 mg/ml (10,000 ppm)
240 Minutes | Identical |
| | | | Doxorubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes | Doxorubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes | Identical |
| | | | Epirubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes | Epirubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes | Identical |
| | | | Etoposide
20 mg/ml (20,000 ppm)
240 Minutes | Etoposide
20 mg/ml (20,000 ppm)
240 Minutes | Identical |
| | | | Fludarabine
25 mg/ml (25,000 ppm)
240 Minutes | Fludarabine
25 mg/ml (25,000 ppm)
240 Minutes | Identical |
| | | | Fluorouracil
50 mg/ml (50,000 ppm)
240 Minutes | Fluorouracil
50 mg/ml (50,000 ppm)
240 Minutes | Identical |
| | | | Gemcitabine
38 mg/ml (38,000 ppm)
240 Minutes | Gemcitabine
38 mg/ml (38,000 ppm)
240 Minutes | Identical |
| CHARACTERISTICS | | STANDARDS | DEVICE PERFORMANCE | | Comparison |
| 510(K) Number | | | PREDICATE | SUBJECT | |
| | 510(K) Number | --- | K231349 | K232654 | |
| | | | Idarubicin HCl
1 mg/ml (1,000 ppm)
240 Minutes | Idarubicin HCl
1 mg/ml (1,000 ppm)
240 Minutes | Identical |
| | | | Ifosfamide
50 mg/ml (50,000 ppm)
240 Minutes | Ifosfamide
50 mg/ml (50,000 ppm)
240 Minutes | Identical |
| | | | Irinotecan
20 mg/ml (20,000 ppm)
240 Minutes | Irinotecan
20 mg/ml (20,000 ppm)
240 Minutes | Identical |
| | | | Mechlorethamine HCl
1 mg/ml (1,000 ppm)
240 Minutes | Mechlorethamine HCl
1 mg/ml (1,000 ppm)
240 Minutes | Identical |
| | | | Melphalan
5 mg/ml (5,000 ppm)
240 Minutes | Melphalan
5 mg/ml (5,000 ppm)
240 Minutes | Identical |
| | | | Methotrexate
25 mg/ml (25,000 ppm)
240 Minutes | Methotrexate
25 mg/ml (25,000 ppm)
240 Minutes | Identical |
| | | | Mitomycin C
0.5 mg/ml (500 ppm)
240 Minutes | Mitomycin C
0.5 mg/ml (500 ppm)
240 Minutes | Identical |
| | | | Mitoxantrone HCl
2 mg/ml (2,000 ppm)
240 Minutes | Mitoxantrone HCl
2 mg/ml (2,000 ppm)
240 Minutes | Identical |
| | | | Paclitaxel
6 mg/ml (6,000 ppm)
240 Minutes | Paclitaxel
6 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 |
| | | | Thiotepa
10 mg/ml (10,000 ppm)
128.1 Minutes | Thiotepa
10 mg/ml (10,000 ppm)
49.1 Minutes | Similar |
| | | | Trisenox
1 mg/ml (1,000ppm) >240
Minutes | Trisenox
1 mg/ml (1,000ppm)
240 Minutes | Identical |
| | | | Vincristine Sulfate
1 mg/ml (1,000 ppm)
240 Minutes | Vincristine Sulfate
1 mg/ml (1,000 ppm)
240 Minutes | Identical |
| Opioid Drugs
Tested with Minimum
Breakthrough Detection
Time | | 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 Skin
Irritation- ISO
10993-23:
First Edition
2021-01 | Under the conditions of the
study, the test article
met the requirements of
the test. | Under the conditions of the
study, the test article
met the requirements of
the test. | Identical | |
| | Dermal
Sensitization-
ISO 10993-10:
Fourth Edition
2021-11 | Under the conditions of the
study, the test article was not
considered a sensitizer. | Under the conditions of the
study, the test article was not
considered a sensitizer. | Identical | |
| | Acute
Systemic
Toxicity- ISO
10993-11:
Third Edition
2017-09 | Under the conditions of the
study, there was no
mortality or evidence of
acute systemic toxicity | Under the conditions of the
study, there was no
mortality or evidence of
acute systemic toxicity | Identical | |

8

9

10

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 | ACCEPTANCE
CRITERIA | RESULTS |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application. | To determine the
length of the
gloves | 220mm minimum for size
XS and S

230mm minimum for size
M, L, XL and XXL | Pass |
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application. | To determine the
width of the
gloves | XS: $70 \pm 10$ mm
S: $80 \pm 10$ mm
M: $95 \pm 10$ mm
L: $110 \pm 10$ mm
XL: $120 \pm 10$ mm
XXL: $130 \pm 10$ mm | Pass |
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application. | To determine the
thickness of the
gloves | Palm: 0.05 mm min
for all sizes

Finger: 0.05 mm min
for all sizes | Pass |

12

K232654

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULTS |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application. | To determine the
physical
properties-
Tensile strength | Before Ageing
Tensile Strength
14MPa min for all sizes
After Ageing
Tensile Strength
14MPa min for all sizes | Pass |
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application. | To determine the
physical
properties-
Ultimate
Elongation | Before Ageing
Ultimate Elongation
500% min for all sizes
After Ageing
Ultimate Elongation
400% min for all sizes | Pass |
| ASTM D5151-19
Standard
Test Method for
Detection
of Holes in Medical | To determine the
holes in the gloves | G-I, AQL 2.5 | Pass |
| ASTM D6124-06
(Reapproved 2017)
Standard
Test Method for Residual
Powder on Medical
Gloves | To determine the
residual powder in
the gloves | ≤ 2 mg/glove | Pass |

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULTS |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| ASTM D6978-05
(Reapproved 2019)
Standard Practice for
Assessment of Resistance
of Medical Gloves to
Permeation by
Chemotherapy Drugs. | To determine the
breakthrough
detection time of
chemotherapy
drugs* | Bleomycin Sulfate
15 mg/ml (15,000 ppm)

240 Minutes | Bleomycin Sulfate
15 mg/ml (15,000 ppm)
240 Minutes |
| | 6 mg/ml (6,000 ppm)
240 Minutes | Busulfan
6 mg/ml (6,000 ppm)
240 Minutes |
| | 10 mg/ml (10,000 ppm)
240 Minutes | Carboplatin
10 mg/ml (10,000 ppm)
240 Minutes |
| | 3.3 mg/ml (3,300 ppm)
33.8 Minutes | Carmustine
3.3 mg/ml (3,300 ppm)
26.3 Minutes |
| | 1 mg/ml (1,000 ppm)
240 Minutes | Cisplatin
1 mg/ml (1,000 ppm)
240 Minutes |
| | 20 mg/ml (20,000 ppm)
240 Minutes | Cyclophosphamide
20 mg/ml (20,000 ppm)
240 Minutes |
| | 100 mg/ml (100,000 ppm)
240 Minutes | Cytarabine
100 mg/ml (100,000 ppm)
240 Minutes |
| | 10 mg/ml (10,000 ppm)
240 Minutes | Dacarbazine
10 mg/ml (10,000 ppm)
240 Minutes |
| TEST METHOD | | 5 mg/ml (5,000 ppm)
240 Minutes | Daunorubicin HCl
5 mg/ml (5,000 ppm)
240 Minutes |
| | 10 mg/ml (10,000 ppm)
240 Minutes | Docetaxel
10 mg/ml (10,000 ppm)
240 Minutes |
| | 2 mg/ml (2,000 ppm)
240 Minutes | Doxorubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes |
| | 2 mg/ml (2,000 ppm)
240 Minutes | Epirubicin HCl
2 mg/ml (2,000 ppm)
240 Minutes |
| | 20 mg/ml (20,000 ppm)
240 Minutes | Etoposide
20 mg/ml (20,000 ppm)
240 Minutes |
| | 25 mg/ml (25,000 ppm)
240 Minutes | Fludarabine
25 mg/ml (25,000 ppm)
240 Minutes |
| | 50 mg/ml (50,000 ppm)
240 Minutes | Fluorouracil
50 mg/ml (50,000 ppm)
240 Minutes |
| | 38 mg/ml (38,000 ppm)
240 Minutes | Gemcitabine
38 mg/ml (38,000 ppm)
240 Minutes |
| | 1 mg/ml (1,000 ppm)
240 Minutes | Idarubicin HCl
1 mg/ml (1,000 ppm)
240 Minutes |
| | 50 mg/ml (50,000 ppm)
240 Minutes | Ifosfamide
50 mg/ml (50,000 ppm)
240 Minutes |
| | 20 mg/ml (20,000 ppm)
240 Minutes | Irinotecan
20 mg/ml (20,000 ppm)
240 Minutes |
| | 1 mg/ml (1,000 ppm)
240 Minutes | Mechlorethamine HCl
1 mg/ml (1,000 ppm)
240 Minutes |
| | 5 mg/ml (5,000 ppm)
240 Minutes | Melphalan
5 mg/ml (5,000 ppm)
240 Minutes |
| | 25 mg/ml (25,000 ppm)
240 Minutes | Methotrexate
25 mg/ml (25,000 ppm)
240 Minutes |
| | 0.5 mg/ml (500 ppm)
240 Minutes | Mitomycin C
0.5 mg/ml (500 ppm)
240 Minutes |
| | 2 mg/ml (2,000 ppm)
240 Minutes | Mitoxantrone HCl
2 mg/ml (2,000 ppm)
240 Minutes |
| TEST METHOD | ASTM D6978-05
(Reapproved 2019)
Standard Practice for
Assessment of Resistance
of Medical Gloves to
Permeation by
Chemotherapy Drugs. | To determine the
breakthrough
detection time of
Opioid drugs | 6 mg/ml (6,000 ppm)
240 Minutes | 6 mg/ml (6,000 ppm)
240 Minutes |
| | (10,000 ppm)
240 Minutes | Rituximab 10
mg/ml (10,000 ppm)
240 Minutes |
| | 10 mg/ml (10,000 ppm)
128.1 Minutes | Thiotepa
10 mg/ml (10,000 ppm)
49.1 Minutes |
| | 1 mg/ml (1,000ppm) >240
Minutes | Trisenox
1 mg/ml (1,000ppm) >240
Minutes |
| | 1 mg/ml (1,000 ppm)
240 Minutes | Vincristine Sulfate
1 mg/ml (1,000 ppm)
240 Minutes |
| | (100mcg/2mL)
240 Minutes | Fentanyl Citrate Injection
(100mcg/2mL)
240 Minutes | | Busulfan
| Carboplatin
| Carmustine
| Cisplatin
| Cyclophosphamide
| Cytarabine
| Dacarbazine
| PURPOSE | ACCEPTANCE CRITERIA | RESULTS |
| Daunorubicin HCl
| Docetaxel
| Doxorubicin HCl
| Epirubicin HCl
| Etoposide
| Fludarabine
| Fluorouracil
| Gemcitabine
| Idarubicin HCl
| Ifosfamide
| Irinotecan
| Mechlorethamine HCl
| Melphalan
| Methotrexate
| Mitomycin C
| Mitoxantrone HCl
| PURPOSE | ACCEPTANCE CRITERIA | RESULTS |
| Rituximab 10 mg/ml
| Thiotepa
| Trisenox
| Vincristine Sulfate
| Fentanyl Citrate Injection

13

K232654

14

K232654

AS REQUIRED BY: 21CFR§807.92

BIOCOMPATIBILITY DATA

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULTS |
|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| ISO 10993-23 First
edition 2021-01
Biological Evaluation of
Medical Devices - Part
23, Tests for Irritation. | To evaluate the
local dermal
irritation of a test
article extract
following
intracutaneous
injection in
rabbits. | Under the condition of study
not an irritant | Under the conditions of the
study, the test article met the
requirements of the test |
| 10993-10 Fourth edition
2021-11 Biological
Evaluation of Medical
Devices - Part 10, Tests
for Skin Sensitization. | To evaluate the
test item, for the
skin sensitization
in Guinea pigs by
maximization test. | Under the conditions of the
study, not a sensitizer | Under the conditions of the
study, the test article was not
considered a sensitizer |
| ISO 10993-11 Third
edition 2017-09
Biological Evaluation of
Medical Devices - Part
11, Tests for Systemic
Toxicity. | To evaluate the
acute systemic
toxicity of a test
article extract
following injection
in mice. | 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. |

15

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.