Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable examination glove and the description focuses on material properties, testing standards, and intended use for preventing contamination and resistance to chemicals. There is no mention of any computational or analytical capabilities that would involve AI/ML.

Therapeutic

No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to provide therapeutic benefit.

Diagnostic

No

The device is a glove, intended to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, clearly described as a tangible product and not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Intended Use: The intended use of these gloves is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
Lack of Specimen Examination: The description does not mention any interaction with or analysis of human specimens for diagnostic purposes.
Device Classification: The device is classified as a Class I patient examination glove (21 CFR 880.6250), which is not an IVD classification.

The testing for chemotherapy drugs and fentanyl resistance relates to the protective barrier function of the glove, not to any diagnostic capability.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

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 following chemotherapy drugs have low permeation times:

Thiotepa (10.0 mg/ml) : 128.1 minutes
Carmustine (3.3 mg/ml) : 33.8 minutes

Warning: Not for Use with: Carmustine, Thiotepa

The tested Opioid is:
Fentanyl Citrate Injection (100 mcg/2 mL). Permeation: no breakthrough up to 240 minutes

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

LZA, LZC, OPJ, QDO

Device Description

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner / Medical purpose

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)

Bench Test Data:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application:
- Purpose: To determine the length of the gloves.
  - Acceptance Criteria: Medium : 230 mm min, Large : 230 mm min, X-Large : 230 mm min, XX-Large : 230 mm min.
  - Result: Medium : 235 mm, Large : 237 mm, X-Large : 250 mm, XX-Large : 238 mm.
- Purpose: To determine the width of the gloves.
  - Acceptance Criteria: Medium : 95+/-10 mm, Large : 110+/-10 mm, X-Large : 120+/-10 mm, XX-Large : 130+/-10 mm.
  - Result: Medium : 95, Large : 113, X-Large : 121, XX-Large : 129.
- Purpose: To determine the thickness of the gloves.
  - Acceptance Criteria: Palm: 0.05 mm min for all sizes, Finger: 0.05 mm min for all sizes.
  - Result: Size Palm Finger Medium 0.077 mm 0.111 mm Large 0.106 mm 0.109 mm X-Large 0.089 mm 0.115 mm XX-Large 0.113 mm 0.107 mm.
- Purpose: To determine the physical properties - Tensile strength.
  - Acceptance Criteria: Before Ageing Tensile Strength 14MPa min for all sizes, After Ageing Tensile Strength 14MPa min for all sizes.
  - Result: Size Before Ageing After Ageing Medium 34.0 MPa 37.3 MPa.
- Purpose: To determine the physical properties - Ultimate Elongation.
  - Acceptance Criteria: Before Ageing Ultimate Elongation 500% min for all sizes, After Ageing Ultimate Elongation 400% min for all sizes.
  - Result: Size Before Ageing After Ageing Medium 542% 503%.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves:
- Purpose: To determine the holes in the gloves.
- Acceptance Criteria: AQL 2.5.
- Result: Gloves Pass AQL 2.5.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves:
- Purpose: To determine the residual powder in the gloves.
- Acceptance Criteria: 240 Minutes breakthrough detection time. Fentanyl Citrate Injection (100mcg/2mL) also showed >240 Minutes breakthrough detection time.

Biocompatibility Data:

ISO 10993-23 First edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation:
- Purpose: To evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits.
- Result: Under the conditions of the study, the test article met the requirements of the test.
ISO 10993-10 Fourth edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization:
- Purpose: To evaluate the test item, for the skin sensitization in Guinea pigs by maximization test.
- Result: Under the conditions of the study, the test article was not considered a sensitizer.
ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity:
- Purpose: To determine the potential of a test article to cause cytotoxicity.
- Result: The undiluted test article extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. Cytotoxicity concern was addressed by acute systemic toxicity testing.
ISO 10993-11 Third edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity:
- Purpose: To evaluate the acute systemic toxicity of a test article extract following injection in mice.
- Result: Under the conditions of study, there was no mortality or evidence of systemic toxicity.

Conclusion: The conclusions drawn from the non-clinical test demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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

Not Found

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.

K223559

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 6, 2023

Nephron Nitrile, LLC. Lou Kennedy Chief Executive Officer 4777 12th Street Extension West Columbia, South Carolina 29172

Re: K231349

Trade/Device Name: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: May 9, 2023 Received: May 9, 2023

Dear Lou Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K231349

Device Name

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

Indications for Use (Describe)

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

Bleomycin Sulfate (15.0 mg/ml)	Doxorubicin HCl (2.0 mg/ml)	Mechlorethamine HCl (1.0 mg/ml)
Busulfan (6.0 mg/ml)	Epirubicin HCl (2.0 mg/ml)	Melphalan (5.0 mg/ml)
Carboplatin (10.0 mg/ml)	Etoposide (20.0 mg/ml)	Methotrexate (25.0 mg/ml)
Cisplatin (1.0 mg/ml)	Fludarabine (25.0 mg/ml)	Mitomycin C (0.5 mg/ml)
Cyclophosphamide (20.0 mg/ml)	Fluorouracil (50.0 mg/ml)	Mitoxantrone HCl (2.0 mg/ml)
Cytarabine (100.0 mg/ml)	Gemcitabine (38.0 mg/ml)	Paclitaxel (6.0 mg/ml)
Dacarbazine (10.0 mg/ml)	Idarubicin HCl (1.0 mg/ml)	Rituximab (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)	Ifosfamide (50.0 mg/ml)	Trisenox (1.0 mg/ml)
Docetaxel (10.0 mg/ml)	Irinotecan (20.0 mg/ml)	Vincristine Sulfate (1.0 mg/ml)

The following chemotherapy drugs have low permeation times: Thiotepa (10.0 mg/ml) : 128.1 minutes Carmustine (3.3 mg/ml) : 33.8 minutes

Warning: Not for Use with: Carmustine, Thiotepa

The tested Opioid is:

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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3

A. APPLICANT INFORMATION

510(K) Owner's Name	Nephron Nitrile, LLC.
Address	4777 12th Street Extension, West Columbia, SC

|
| Phone | 844-937-3888 |
| Fax | 1-803-926-9853 |
| E-mail | lkennedy@nephronpharm.com |
| Contact Person | Lou Kennedy |
| Designation | Chief Executive Officer |
| Contact Number | 1-803-569-3110 |
| Contact Email | lkennedy@nephronpharm.com |
| Date Prepared | 31 May 2023 |

B. DEVICE IDENTIFICATION

| Name of the device | Nephron Nitrile Powder-Free Nitrile Examination
Gloves (Tested For Use With Chemotherapy
Drugs and Fentanyl) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | Nephron Nitrile |
| Common or usual name | Nitrile Examination Gloves (Tested for use with
Chemotherapy drugs and Fentanyl) |
| 510(k) Number | K231349 |
| Classification name | Patient Examination Glove, Specialty |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, OPJ, QDO |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

C. PREDICATE DEVICE

| Predicate Device | Nephron Nitrile Powder-Free Nitrile Examination
Gloves (Tested For Use With Chemotherapy
Drugs) |
|------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Number | K223559 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC, OPJ |
| Owner | Nephron Nitrile, LLC. |

4

D. DESCRIPTION OF THE DEVICE:

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

E. INDICATION FOR USE OF THE DEVICE:

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to		The tested
240 minutes:		Opioid is:
Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)	Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)	Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)	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) : 33.8 minutes
Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa		minutes

5

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

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
	PREDICATE	SUBJECT
510(K) Number	---	K223559	K231349
Name of device	---	Nephron Nitrile Powder-
Free Nitrile Examination
Gloves (Tested For Use
With Chemotherapy Drugs)	Nephron Nitrile Powder-Free
Nitrile Examination Gloves
(Tested For Use With
Chemotherapy Drugs and
Fentanyl)	Different:
Except for the
addition of
Fentanyl for
subject device,
it is identical
Product Code	---	LZA, LZC, OPJ	LZA, LZC, OPJ, QDO	Different:
Added one
product code
Indication for 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.	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.	Different:
Except for the
addition of
Fentanyl for
subject device,
it is identical
Note: Adding the
Fentanyl to the
indication
does not affect the
intended use.
Regulation Number	---	21 CFR 880.6250	21 CFR 880.6250	Identical
Material	---	Nitrile	Nitrile	Identical
Color	---	Blue	Blue	Identical
Size	---	M, L, XL, XXL	M, L, XL, XXL	Identical
Single Use	---	Single-use	Single-use	Identical
CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
		PREDICATE	SUBJECT
510(K) Number	---	K223559	K231349
Sterile/non sterile	---	Non Sterile	Non Sterile	Identical
Rx Only or OTC	---	OTC	OTC	Identical
Dimensions - Length	ASTM
D6319-19	Minimum 230 mm
(sizes M - XXL)	Minimum 230 mm
(sizes M - XXL)	Identical
Dimensions - Width	ASTM
D6319-19	M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
XXL: 130±10 mm	M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
XXL: 130±10 mm	Identical
Physical Properties-
Tensile Strength	ASTM
D63192019	Before aging
14MPa, min	Before aging
14MPa, min	Identical
		After aging
14MPa, min	After aging
14MPa, min	Identical
Physical Properties-
Ultimate Elongation	ASTM
D63192019	Before aging
500%, min	Before aging
500%, min	Identical
		After aging
400%, min	After aging
400%, min	Identical
Thickness	ASTM
D6319-19	Palm: Minimum 0.05 mm
Finger: Minimum 0.05
mm	Palm: Minimum
0.05 mm
Finger: Minimum
0.05 mm	Identical
Powder Free Residue	ASTM D6319-
19	≤ 2 mg per glove	≤ 2 mg per glove	Identical
Freedom from holes	ASTM D5151-
2019	In accordance 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
Chemotherapy Drugs
Tested with Minimum
Breakthrough Detection
Time	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 | |
| | | Busulfan
6 mg/ml (6,000 ppm)
240 Minutes | Busulfan
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)
33.8 Minutes | Identical | |
| | | Cisplatin
1 mg/ml (1,000 ppm)
240 Minutes | Cisplatin
1 mg/ml (1,000 ppm)
240 Minutes | Identical | |
| CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | PREDICATE | SUBJECT | Comparison |
| 510(K) Number | --- | K223559 | K231349 | | |
| | | 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 | |
| | | 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 | |
| AS REQUIRED BY: 21CFR§807.92 | | | | | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | |
| | | PREDICATE | SUBJECT | Comparison | |
| 510(K) Number | --- | K223559 | K231349 | | |
| | | 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)
128.1 Minutes | Identical | |
| | | Trisenox
1 mg/ml (1,000 ppm)
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) | Not tested | Fentanyl Citrate Injection
(100mcg/2mL) >240 Minutes | *Different | |
| 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: | 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 | |
| CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | | | |
| | | PREDICATE | SUBJECT | Comparison | |
| 510(K) Number | | K223559 | K231349 | | |
| | In vitro
cytotoxicity-
ISO 10993-5:
Third Edition
2009-06-01 | Under the Conditions of the
study, the
undiluted test article
extract and 50% test article
extract dilution did
not meet the requirements of
the test and the 25%,
12.5%, 6.25%, and
3.13% test article extract
dilutions met
the requirements of the test. | Under the conditions of the
study, the
undiluted test article
extract and 50% test article
extract dilution did
not meet the requirements of
the test and the 25%,
12.5%, 6.25%, and
3.13% test article extract
dilutions met
the requirements of the test. | Identical | |
| | Acute
Systemic
Toxicity- ISO
10993-11:
Third Edition
2017.09 | Under the conditions of the
study, there was no mortality
or evidence of systemic
toxicity | Under the conditions of the
study, there was no mortality or
evidence of systemic toxicity | Identical | |

6

7

510(K) SUMMARY K231349

AS REQUIRED BY: 21CFR§807.92

8

510(K) SUMMARY K231349

Fourth Edition 2021-11

9

Identical except for the addition of Fentany], which is the subject of this submission.

There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319-19 and D6978-05 (2019).

G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

BENCH TEST DATA

TEST METHOD	PURPOSE	ACCEPTANCE CRITERIA	RESULT
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application.	To determine the
length of the gloves	Medium : 230 mm min
Large : 230 mm min
X-Large : 230 mm min
XX-Large : 230 mm min	Medium : 235 mm
Large : 237 mm
X-Large : 250 mm
XX-Large : 238 mm
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application.	To determine the
width of the gloves	Medium : 95+/-10 mm
Large : 110+/-10 mm
X-Large : 120+/-10 mm
XX-Large : 130+/-10 mm	Medium : 95
Large : 113
X-Large : 121
XX-Large : 129
ASTM D6319-19
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	Size Palm Finger Medium 0.077 mm 0.111 mm Large 0.106 mm 0.109 mm X-Large 0.089 mm 0.115 mm XX-Large 0.113 mm 0.107 mm

10

510(K) SUMMARY

K231349

AS REQUIRED BY: 21CFR§807.92

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT | | | | | | |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | | | | |
| 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 | Size Before
Ageing After
Ageing Medium 34.0 MPa 37.3 MPa | | | | | | |
| | 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 | Size Before
Ageing After
Ageing Medium 542% 503% | | | | | | |
| ASTM D5151-19 Standard
Test Method for Detection
of Holes in Medical Gloves | To determine the
holes in the gloves | AQL 2.5 | Gloves Pass 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 | ≤ 2 mg/glove | Medium: 0.3516 mg/glove | | | | | | |

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| 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 15mg/ml
(15,000 ppm) >240 Minutes | Bleomycin Sulfate 15 mg/ml
(15,000 ppm) >240 Minutes |
| | | Busulfan 6 mg/ml
(6,000 ppm) >240 Minutes | Busulfan 6 mg/ml
(6,000 ppm) >240 Minutes |
| | | Carboplatin 10 mg/ml
(10,000 ppm) >240 Minutes | Carboplatin 10 mg/ml
(10,000 ppm) >240 Minutes |
| | | Cisplatin 1 mg/ml
(1,000 ppm) >240 Minutes | Cisplatin 1 mg/ml
(1,000 ppm) >240 Minutes |
| | | Cyclophosphamide 20 mg/ml
(20,000 ppm) >240 Minutes | Cyclophosphamide 20 mg/ml
(20,000 ppm) >240 Minutes |
| | | Cytarabine 100 mg/ml
(100,000 ppm) >240 Minutes | Cytarabine 100 mg/ml
(100,000 ppm) >240 Minutes |
| | | Dacarbazine 10 mg/ml
(10,000 ppm) >240 Minutes | Dacarbazine 10 mg/ml
(10,000 ppm) >240 Minutes |
| | | Daunorubicin HCl 5 mg/ml
(5,000 ppm) >240 Minutes | Daunorubicin HCl 5 mg/ml
(5,000 ppm) >240 Minutes |
| | | Docetaxel 10 mg/ml
(10,000 ppm) >240 Minutes | Docetaxel 10 mg/ml
(10,000 ppm) >240 Minutes |
| | | Doxorubicin HCl 2 mg/ml
(2,000 ppm) >240 Minutes | Doxorubicin HCl 2 mg/ml
(2,000 ppm) >240 Minutes |
| | | Epirubicin HCl 2 mg/ml
(2,000 ppm) >240 Minutes | Epirubicin HCl 2 mg/ml
(2,000 ppm) >240 Minutes |
| AS REQUIRED BY: 21CFR§807.92 | | | |
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
| | | (2,000 ppm) >240 Minutes | (2,000 ppm) >240 Minutes |
| | | Etoposide 20 mg/ml
(20,000 ppm) >240 Minutes | Etoposide 20 mg/ml
(20,000 ppm) >240 Minutes |
| | | Fludarabine 25 mg/ml
(25,000 ppm) >240 Minutes | Fludarabine 25 mg/ml
(25,000 ppm) >240 Minutes |
| | | Fluorouracil 50 mg/ml
(50,000 ppm) >240 Minutes | Fluorouracil 50 mg/ml
(50,000 ppm) >240 Minutes |
| | | Gemcitabine 38 mg/ml
(38,000 ppm) >240 Minutes | Gemcitabine 38 mg/ml
(38,000 ppm) >240 Minutes |
| | | Idarubicin HCl 1 mg/ml
(1,000 ppm) >240 Minutes | Idarubicin HCl 1 mg/ml
(1,000 ppm) >240 Minutes |
| | | Ifosfamide 50 mg/ml
(50,000 ppm) >240 Minutes | Ifosfamide 50 mg/ml
(50,000 ppm) >240 Minutes |
| | | Irinotecan 20 mg/ml
(20,000 ppm) >240 Minutes | Irinotecan 20 mg/ml
(20,000 ppm) >240 Minutes |
| | | Mechlorethamine HCl 1 mg/ml
(1,000 ppm) >240 Minutes | Mechlorethamine HCl 1 mg/ml
(1,000 ppm) >240 Minutes |
| | | Melphalan 5 mg/ml
(5,000 ppm) >240 Minutes | Melphalan 5 mg/ml
(5,000 ppm) >240 Minutes |
| | | Methotrexate 25 mg/ml
(25,000 ppm) >240 Minutes | Methotrexate 25 mg/ml
(25,000 ppm) >240 Minutes |
| | | Mitomycin C 0.5 mg/ml
(500 ppm) >240 Minutes | Mitomycin C 0.5 mg/ml
(500 ppm) >240 Minutes |
| | | Mitoxantrone HCl 2 mg/ml
(2,000 ppm) >240 Minutes | Mitoxantrone HCl 2 mg/ml
(2,000 ppm) >240 Minutes |
| | | Paclitaxel 6 mg/ml
(6,000 ppm) >240 Minutes | Paclitaxel 6 mg/ml
(6,000 ppm) >240 Minutes |
| | | Rituximab 10 mg/ml
(10,000 ppm) >240 Minutes | Rituximab 10 mg/ml
(10,000 ppm) >240 Minutes |
| | | Trisenox 1 mg/ml
(1,000 ppm) >240 Minutes | Trisenox 1 mg/ml
(1,000 ppm) >240 Minutes |
| | | Vincristine Sulfate 1 mg/ml
(1,000 ppm) >240 Minutes | Vincristine Sulfate 1 mg/ml
(1,000 ppm) >240 Minutes |
| ASTM D6978-05
(Reapproved 2019)
Standard Practice for
Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy | To determine the
breakthrough
detection time of
Opioid
drugs | Fentanyl Citrate Injection
(100mcg/2mL) >240 Minutes | Fentanyl Citrate Injection
(100mcg/2mL) >240 Minutes |

11

510(K) SUMMARY

K231349

AS REQUIRED BY: 21CFR§807.92

12

BIOCOMPATIBILITY DATA

TEST METHOD	PURPOSE	ACCEPTANCE CRITERIA	RESULT
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 10993-5 Third edition
2009-06-01 Biological
Evaluation of Medical
Devices - Part 5, Tests for
In Vitro Cytotoxicity.	To determine the
potential of a test
article to cause
cytotoxicity	Under the conditions of the study,
non-cytotoxic	The undiluted test
article extract and 50%
test article extract
dilution did not meet
the requirements of the
test and the 25%.
12.5%, 6.25%, and
3.13% test article
extract dilutions met
the requirements of the
test. Cytotoxicity
concern was addressed
by acute systemic
toxicity testing.
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 a
systemic toxicity concern	Under the conditions
of study, there was no
mortality or evidence
of systemic toxicity.

The performance test data of the non-clinical tests meet following standards:

ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical

Application.

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.

ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

13

510(K) SUMMARY K231349

AS REQUIRED BY: 21CFR§807.92

ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation.

ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.

ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.

ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.

H. CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves.

CONCLUSION I.

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) K231349 submission, Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K223559.