Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the summary describes standard testing for physical properties and resistance to chemicals, with no mention of AI or ML.

Therapeutic

No.
The device is a glove intended to prevent contamination between the patient and examiner, not to provide therapy or treatment.

Diagnostic

No
The device is a medical glove intended to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile gloves) and the description focuses on material properties, physical testing, and resistance to chemicals, not software functionality.

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 "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: The device is described as "patient examination gloves."
Regulatory Classification: The device is classified as Class I with product codes LZA, LZC, OPJ (21CFR880.6250). These codes correspond to "Patient Examination Gloves," which are not IVDs.
Performance Studies: The performance studies focus on physical properties, freedom from holes, residual powder, resistance to chemotherapy drugs, and biocompatibility. These are all related to the barrier function and safety of the glove, not to diagnostic testing.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform such a function.

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

Warning: Not for Use with: Carmustine, Thiotepa

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

LZA, LZC, OPJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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)

Non-clinical testing was performed to demonstrate substantial equivalence. These tests include:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: Evaluated length, width, thickness, tensile strength, and ultimate elongation.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves: Evaluated freedom from holes (AQL 2.5).
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: Evaluated residual powder content.
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Determined breakthrough detection time for various chemotherapy drugs.
ISO 10993-23 First edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation: Evaluated primary skin irritation.
ISO 10993-10 Fourth edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization: Evaluated skin sensitization.
ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity: Determined the potential for cytotoxicity.
ISO 10993-11 Third edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity: Evaluated acute systemic toxicity.

Key results:

Length: Medium: 235 mm, Large: 237 mm, X-Large: 250 mm, XX-Large: 238 mm (all met min 230 mm).
Width: Medium: 95 mm, Large: 113 mm, X-Large: 121 mm, XX-Large: 129 mm (all met specified ranges).
Thickness: Palm: 0.077-0.113 mm, Finger: 0.107-0.115 mm (all met min 0.05 mm).
Tensile Strength (Medium size results shown): Before aging 34.0 MPa (met min 14MPa), After aging 37.3 MPa (met min 14MPa).
Ultimate Elongation (Medium size results shown): Before aging 542% (met min 500%), After aging 503% (met min 400%).
Freedom from holes: Gloves Passes AQL 2.5.
Residual powder: Medium: 0.3516 mg/glove (met ≤ 2 mg/glove).
Chemotherapy drug permeation: For most listed drugs, no breakthrough was detected up to 240 minutes, meeting acceptance criteria. Carmustine (3.3 mg/ml): 33.8 minutes, Thiotepa (10.0 mg/ml): 128.1 minutes.
Biocompatibility:
- Irritation: Met the requirements of the test.
- Sensitization: Was not considered a sensitizer.
- Cytotoxicity: Undiluted extract and 50% extract dilution did not meet requirements, but 25%, 12.5%, 6.25%, and 3.13% dilutions met the requirements. Cytotoxic concern addressed via acute systemic toxicity testing.
- Systemic Toxicity: No mortality or evidence of systemic toxicity.

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.

K213440

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.

K211003

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). 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.

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.

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

2

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

|
| Phone | 1-803-569-3110 |
| 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 Submitted | 21 October 2022 |

B. DEVICE IDENTIFICATION

| Name of the device | Nephron Nitrile Powder-Free Nitrile Examination
Gloves (Tested For Use With Chemotherapy
Drugs) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | Nephron Nitrile |
| Common or usual name | Nitrile Examination Gloves (Tested for use with
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,
Purple-Blue), Tested for Use with Chemotherapy
Drugs |
|------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213440 |
| Regulatory Class | Class-1 |
| Product code | LZA, LZC |

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

4

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

5

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
Nitrile
Examination
Gloves (Blue,
Purple-Blue),
Tested for Use with
Chemotherapy
Drugs	SHOWA® Blue
Nitrile Powder Free
Medical Examination
Glove	Nephron Nitrile
Powder-Free Nitrile
Examination Gloves
(Tested For Use With
Chemotherapy Drugs)	Similar
to
predicate
device
Product Code	---	LZA, LZC	LZA, LZC	LZA, LZC, OPJ	Similar
Indication for use	---	Powder Free
Nitrile
Examination
Gloves (Blue,
Purple-Blue),
Tested for Use with
Chemotherapy
Drugs is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hand to
prevent
contamination
between patient
and examiner.	A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the
examiner's hands or
fingers to prevent
contamination
between patient and
examiner.
These gloves were
tested for use with
chemotherapy drugs in
accordance with
ASTM D6978-05
Standard Practice for
Assessment of
Medical Glove to
Permeation by
chemotherapy drugs.	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.	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

6

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
S: 80±10
M: 95±10
L: 110±10
XL: 120±10
XXL: 130±10	Width (± 10 mm)
Size XS = 70 mm
Size S = 80 mm
Size M = 95 mm
Size L = 110 mm
Size XL = 120 mm	M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
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
Average value = 34.0 MPa (Medium)	Same
		After aging 14MPa, min	After aging (MPa) = 14 min	After aging 14MPa, min
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
Average value = 542% (Medium)	Same
		After aging 400%, min	After aging (%) = 400 min	After aging 400%, min
Average value = 503% (Medium)	Same
Thickness	ASTM D6319-19	Palm: Minimum 0.05 mm
Finger: Minimum 0.05 mm	Palm (mm) = 0.05 min
Finger Tip (mm) = 0.05 min	Palm: Minimum 0.05 mm
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

7

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		PREDICATE	REFERENCE	SUBJECT
510(K) Number		K213440	K211003
Powder Free Residue	ASTM
D6319-19	≤ 2 mg per glove	≤ 2.0 mg/pc	≤2 mg per glove
Average value = 0.3516
mg/glove (Medium)	Same
Freedom from holes	ASTM D5151-
2019	In accordance with
ASTM D 5151-19,
following ASTM
D6319-19,
G-I, AQL 2.5	AQL 2.5
Inspection Level
G-1	In accordance with
ASTM D 5151-19,
following ASTM
D6319-19,
G-I, AQL 2.5	Same
Chemotherapy Drugs
Tested with Minimum
Breakthrough
Detection Time	ASTM D6978-
05 (2019)	Bleomycin Sulfate
15 mg/ml (15,000 ppm)

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

8

9

10

Predicate device / reference device perform additional Chemotherapy drug test.

Reference device has been included in the 510k to prove the safety of subject device with respect to the use of chemotherapy drug Cytarabine and Docetaxel which was not tested in case of predicate device.

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).

11

G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

BENCH TEST DATA

TEST METHOD	PURPOSE	ACCEPTANCE CRITERIA
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
X-Large : 130+/-10 mm	Medium : 95 mm
Large : 113 mm
X-Large : 121 mm
XX-Large : 129 mm
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
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 Passes 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

12

TEST METHOD	PURPOSE	ACCEPTANCE CRITERIA
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
		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
		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

13

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. The
cytotoxic concern was
addressed via 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 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.

14

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.

I. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K213440.