Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical barrier (examination glove) and the description focuses on material properties and performance standards, with no mention of AI/ML.

Therapeutic

No
The device, examination gloves, is intended to prevent contamination and does not claim to treat or cure any condition or disease.

Diagnostic

No

This device is a medical glove designed to prevent contamination, not to diagnose a condition or disease. Its primary function is a barrier, not a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device is a physical glove, not software. The description details physical properties, materials, and testing related to a tangible 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 is to prevent contamination between the examiner and patient by being worn on the hand or finger. This is a physical barrier function.
Mechanism of Action: The mechanism of action is described as preventing contamination through barrier properties and physical characteristics.
Testing: The testing performed (ASTM standards for gloves, chemical permeation, biocompatibility) focuses on the physical and barrier properties of the glove, not on analyzing samples from the human body.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.

The device is clearly described as a medical examination glove, which is a Class I or Class II medical device depending on its intended use and claims, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment 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

Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger

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)

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test result demonstrated that the proposed device met the performance criteria with the following standards:

ASTM D6319-10: Physical Dimension (Passed), Physical Properties (Passed)
ASTM D6124-06(2017): Powder Residual (Passed)
ASTM D5151-19: Freedom from Holes (Watertight @1000ml) (Passed)
ISO 10993-10:2010: Irritation and delayed-type hypersensitivity (No skin sensitization and irritation, Passed)
ISO 10993-5:2009: Cytotoxicity (Cytotoxicity reaction, Failed)
ISO 10993-11:2017: Acute Systemic toxicity (Passed)
ASTM D6978: Chemical Permeation for various chemotherapy drugs and Fentanyl Citrate. Most showed breakthrough times > 240 minutes, except for Carmustine (BCNU) at 24.3 minutes and ThioTepa at 48.6 minutes. Observations mostly showed "Slight swelling and no degradation," with "Moderate swelling and no degradation" for Carmustine and ThioTepa.

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.

K192954

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.

March 30, 2023

Professional Latex Sdn Bhd Kok Yoon Lim Managing Director Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1 Kawasan Perusahaan Kamunting Raya, Kamunting, Perak Darul Ridzuan 34600 Malaysia

Re: K220088

Trade/Device Name: Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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: January 5, 2023 Received: March 2, 2023

Dear Kok Lim:

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) K220088

Device Name

Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested Chemotherapy Drugs and	Minimum
Concentration: Cisplatin, 1.0 mg/ml	> 240
Cyciophosphamide (Cytoxan), 20.0 mg/ml	> 240
Dacarbazine, 10.0 mg/ml	> 240
Doxorubicin HCI, 2.0 mg/ml	> 240
Etoposide, 20.0 mg/ml	> 240
Fluorouracil, 50.0 mg/ml	> 240
Ifosfamide, 50.0 mg/ml	> 240
Methotrexate, 25.0 mg/ml	> 240
Mitomycin C, 0.5 mg/ml	> 240
Mitoxantrone, 2.0 mg/ml	> 240
Paclitaxel, 6.0 mg/ml	> 240
Vincristine Sulfate, 1.0 mg/ml	> 240
Carmustine (BCNU), 3.3 mg/ml	24.3
ThioTepa, 10.0 mg/ml	48.6

Fentanyl Citrate Injection 100.0 mcg/2ml

Breakthrough Detection Time (minutes)

3

WARNING.

Please note that the following drugs have extremely low permeation time:

Carmustine (BCNU), 3.3 mg/ml : 24.3 minutes and Thiotepa, 10.0 mg/ml : 48.6 minutes Do not use with Carmustine and 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740 E

4

510(K) SUMMARY K220088

1.0	Submitter
	Professional Latex Sdn Bhd
	Lot Plant 2: Lot 20734 & 20735, Lengkungan
	Perusahaan Kamunting 3/1, Kawasan Perusahaan
	Kamunting Raya, 34600 Kamunting, Perak Darul
	Ridzuan, Malaysia.

Tel:	+605 891 6650
Name Of Contact Person:	Foong Kah Kah
Email Address:	foongkk@professionallatex.com
Date of Summary Prepared:	25 March, 2023

2.0 Name of Device

Trade Name:

Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

510(K) Number:	K220088
Classification Name:	Polymer Patient Examination Glove
Patient Examination Gloves, Specialty
Fentanyl And Other Opioid Protection Glove
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital
Device Class:	I
Product Code:	LZA, LZC, OPJ, QDO

3.0 Identification of The Legally Marketed Device

Predicate Device Name: Blue Colored, Powder Free Nitrile Patient Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Company:	Comfort Rubber Gloves Industries Sdn. Bhd
Predicate 510(K) Number:	K192954

5

4.0 Description of Device

Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.

5.0 Intended Use/Indications for Use of Glove

Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Minimum Breakthrough Detection Time (Minutes)

Cisplatin, 1.0 mg/ml	> 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml	> 240
Dacarbazine, 10.0 mg/ml	> 240
Doxorubicin HCI, 2.0 mg/ml	> 240
Etoposide, 20.0 mg/ml	> 240
Fluorouracil, 50.0 mg/ml	> 240
Ifosfamide, 50.0 mg/ml	> 240
Methotrexate, 25.0 mg/ml	> 240
Mitomycin C, 0.5 mg/ml	> 240
Mitoxantrone, 2.0 mg/ml	> 240
Paclitaxel, 6.0 mg/ml	> 240
Vincristine Sulfate, 1.0 mg/ml	> 240
Carmustine (BCNU), 3.3 mg/ml	24.3
ThioTepa, 10.0 mg/ml	48.6
Fentanyl Citrate Injection 100.0mcg/2ml	> 240

6

WARNING.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU), 3.3mg/ml : 24.3 minutes and ThioTepa, 10.0mg/ml : 48.6 minutes.

Do not use with Carmustine and ThioTepa.

Summary of the Technologies Characteristic of the Device compared to the 6.0 Predicate Device

Powdered Free Nitrile Examination Gloves, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following characteristics compared to to ASTM D6139-10 Standard technological Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in table.

7

Characteristics	510(K)		Device Performance		Comparison Result
	Standards	Number	Predicate device
K192954	Subject device
K220088
Regulation
Number			21 CFR 880.6250	21 CFR 880.6250	Same.
Product Code			LZA, LZC, QDO	LZA, LZC,
QDO,OPJ	Similar
Material	ASTM-D6319-10		Synthetic Nitrile
rubber	Synthetic Nitrile
rubber	Same.
Size	ASTM-D6319-10		Extra Small
Small
Medium
Large
Extra Large	Extra Small
Small
Medium
Large
Extra Large	Same.
Physical
Dimension	ASTM-D6319-10		Length:
Min 240mm
Thickness Palm &
finger:
Min: 0.05
Width by sizes:
XS - 70mm
S - 80mm
M - 95mm
L -110mm
XL - 120mm
Tolerance:
± 10mm	Length
Min: 240mm
Thickness Palm
& finger:
Min: 0.05
Width by sizes:
XS - 70mm
S - 80mm
M - 95mm L
L - 110mm
XL - 120mm
Tolerance:
± 10mm	Similar
Meeting the
requirements of
Dimension
under ASTM-
D6319-10.
Physical
Properties	ASTM-D6319-10		Tensile Strength
Before Aged:
Min: 14MPa
After Aged:
Min: 14MPa
Ultimate
Elongation:
Before aged:
Min 500%
After aged:
Min 400%	Tensile Strength
Before Aged:
Min: 14MPa
After Aged:
Min: 14MPa
Ultimate
Elongation:
Before aged:
Min 500%
After aged:
Min 400%	Similar
Meeting the
requirements of
physical
properties
under ASTM-
D6319-10.
Powder
Content	ASTM-D6124-
06(2017)	Powder Amount:
$\leq 2mg$	Powder Amount:
$\leq 2mg$	Similar
Meeting the
requirements of
Powder Content
under ASTM-
D6124-
06(2017).
Freedom from
Holes
(Watertight
@1000ml)	21 CFR 800.20
ASTM D5151	Meets ASTM
D6139-10 and
ASTM D5151-06
requirements of
AQL 2.5	AQL .2,5	Similar
Meeting the
freedom from
holes
requirement
under ASTM-
D5151
Color	No standards
requirements	Blue	Blue	Similar
Both are similar
in color
Single Use	Designated as
single use gloves	Single use	Sigle use	Same. Both are
single use
gloves.
Sterility	Designated as non-
sterile gloves	No sterility report
as sold as non-
sterile	No sterility
report as sold as
non-sterile	Same. Both are
non-sterilized
Gloves

Table 1: Technological Characteristic Comparison Table

8

Table 2: Powder Free Examination Gloves, Non-sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Characteristics	Standard	510(K) Number	Device Performance		Comparison result
Chemotherapy
Drugs Permeation
Test	ASTM
D6978-
05		Predicate device	Subject device
K220088
Chemotherapy Drug	Concentration
mg/ml		Minimum Breakthrough
Detection Time (Minutes)
Cisplatin	1.0		≥ 240	> 240	Similar
Cyclophosphamide
(Cytoxan)	20.0		≥ 240	> 240	The chemotherapy
drugs tested have
Dacarbazine	10.0		≥ 240	> 240	similar
Doxorubicin HCI	2.0		≥ 240	> 240	breakthrough

9

Fluorouracil	50.0	> 240	> 240
Ifofamide	50.0	-	> 240
Methotrexate	25.0	-	> 240
Mitomycin C	0.5	-	> 240
Mitoxantrone	2.0	-	> 240
Paclitaxel	6.0	≥ 240	> 240
Vincristine Sulfate	1.0	-	> 240
*Carmustine
(BCNU)	3.3	18.2	24.3
*ThioTepa	10.0	57.3	48.6
Fentanyl Citrate
Injection	*100 mcg/2ml	≥ 240	> 240
Characteristic	510(K)
Number	Device Performance		Comparison result
		Predicate device
K192954	Subject device
K220088
Warning Statement		Warning:
Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU):
18.2 minutes and
ThioTepa: 57.3
minutes	WARNING.
Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU, 3.3
mg/ml: 24.3 minutes and
ThioTepa,10.0mg/ml :
48.6 minutes

Do not use with
Carmustine and
ThioTepa | Similar
The
chemotherapy
drugs tested
have similar
breakthrough
detection times
and the drug
with low
permeation time. |

Table 3: Biocompatible Characteristic & Indication for Use Comparison Table

| Characteri
stics | 510(K)
Number | Device Performance | | Comparison result |
|----------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Standards | Predicate device | Subject device | |
| Biocomp
atibility | Primary Skin
Irritation
ISO 10993-
10:2010 | Passed.
Under the
conditions of the
study, the subject
device is non-
Irritating | Passed.
Under the
conditions of the
study, the subject
device is non-
irritating | Same.
Both are tested to
be non-irritant. |
| | Dermal
Sensitization
ISO 10993- | Passed.
Under the condition
of the study, the | Passed.
Under the condition
of the study, the | Same.
Both are tested to
be non-sensitizer |

10

| 10: 2010 | subject device is
non-sensitizer | subject device is
non-sensitizer | subject device is
non-sensitizer |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Cytotoxicity
ISO 10993-5:
2009 | Exhibits severe
cytotoxicity
reactivity at 100%,
and 66% extract
concentrations and
no cytotoxicity
reactivity at 44%,
30%, 20% and 15%
extract
concentrations
under the condition
of this test. | It is concluded that,
undiluted, 1:2 and
1:4 dilution is
cytotoxicity and the
dilution 1:8 and 1:16
and 1:32 us non-
cytotoxic. | Same |
| Acute
Systemic
toxicity
ISO 10993-
11: 2017 | Under the condition
of the study, no
evidence of
systemic toxicity | Under the conditions
of the study, the
subject showed no
adverse biological
reaction | Same.
Both are tested to
be non-systemic
toxicity |

Characteristics	Device Performance
Indication
for Use	Predicate device	Subject device	Comparison
result
	510(K) Number: K192954	510(K) Number: K220088
	The Blue Colored, Powder Free
Nitrile Examination Gloves, Non-
sterile, and Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate is a specialty medical glove
which is a disposable device
intended for medical purpose that is
worn on the examiner's hand or
finger to prevent contamination
between examiner and patient. The
gloves was tested for use with
Chemotherapy Drugs and Fentanyl
Citrate as per ASTM D6978-05
Standard Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs.

Tested chemotherapy drugs are as
follows: | Powder free Nitrile
Examination Gloves, Non-
Sterile and tested for use
with Chemotherapy Drugs
and Fentanyl Citrate is a
patient medical exam
gloves which is a disposal
device intended for medical
purposes that is worn on
the examiners' hand or
finger to prevent
contamination between
examiner and patient.

The glove was tested for
use with Chemotherapy
Drugs and Fentanyl
Citrate as per ASTM-
D6978-05 Standard
Practice for Assessment of
Medical Gloves to permeation
by chemotherapy Drugs | Similar
Both
indication
for use is
similar. |

11

Average Breakthrough Detection Time (minutes)	Tested Chemotherapy Drugs and Concentration
Cisplatin 1.0 mg/ml - ≥ 240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) - ≥ 240
Dacarbazine (DTIC) (10.0mg/ml) - ≥ 240
Doxorubicin Hydrochloride (2.0mg/ml) - ≥ 240
Etoposide (20.0 mg/ml) - ≥ 240
Fluorouracil (50.0 mg/ml) - > 240
Paclitaxel (Taxol) (6.0 mg/ml) – > 240
Carmustine (BCNU) 3.3mg/ml 18.2
Thiotepa (THT) 10.0mg/ml 57.3	Minimum Breakthrough Detection Times (Minutes)
Cisplatin 1.0mg/ml - > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml - > 240
Dacarbazine 10.0mg/ml - > 240
Doxorubicin HCI 2.0mg/ml - > 240
Etoposide 20.0mg/m - > 240
Fluorouracil 50.0mg/ml -> 240
Ifosfamide 50.0mg/ml - > 240
Methotrexate 25.0mg/ml - > 240
Mitomycin C 0.5mg/ml - > 240.0
Mitoxantrone 20.0mg/ml - > 240
Paclitaxel - 6.0mg/ml > 240
Vincristine Sulfate -> 240
Carmustine (BCNU) 3.3mg/ml - 24.3
Thiotepa 10.0mg/ml - 48.6
Fentanyl Citrate Injection (100mcg/2ml) - > 240
Tested Fentanyl Citrate is as follows:
Average Breakthrough Detection Time (minutes)
Fentanyl Citrate Injection 100.0 mg/2ml ≥ 240
Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU) 18.2 minutes and Thiotepa: 57.3 minutes
Warning: Do not use with Carmustine	WARNING. Please note that the following drugs have extremely low permeation time:
Carmustine (BCNU) 3.3 mg/ml 24.3 minutes and Thiotepa 10.0mg/ml 48.6 minutes
Do not use with Carmustine and Thiotepa

12

7.0 Summary of Non-Clinical Performance Data

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications.

The test result demonstrated that the proposed device met the performance criteria with the following standards:

| Standar
d | Purpose | Acceptance Criteria | Result /
Conclusion |
|--------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| ASTM
D6319
-10 | Physical
Dimension | Length:
Min 240mm Thickness Palm & finger:
Min 0.05mm
Width by sizes: XS - 70mm

After Aged:
Min: 14MPa Ultimate
Elongation: Before aged:
Min 500%

After aged: Min 400% | Passed |
| ASTM
D6124
-06
(2017) | Powder
Residual | Powder Amount:
240 | Slight
swelling
and no
degradation |
| | | Cyciophospha
mide | 20.0 | > 240 | Slight
swelling
and no
degradation |
| | | Dacarbazine | 10.0 | > 240 | Slight
swelling
and no
degradation |
| | | Doxorubicin
HCI | 2.0 | > 240 | Slight
swelling
and no
degradation |
| | | Etoposide | 20.0 | > 240 | Slight
swelling
and no
degradation |
| | | Fluorouracil | 50.0 | > 240 | Slight
swelling
and no
degradation |
| | | Ifosfamide | 50.0 | > 240 | Slight
swelling
and no
degradation |
| | | Methotrexate | 25.0 | > 240 | Slight
swelling
and no
degradation |
| | | Mitomycin C | 0.5 | > 240 | Slight
swelling
and no
degradation |
| | | Mitoxantrone | 2.0 | > 240 | Slight
swelling
and no
degradation |
| | | Paclitaxel | 6.0 | > 240 | Slight
swelling
and no
degradation |
| | | Vincristine
Sulfate | 1.0 | > 240 | Slight
swelling
and no
degradation |

14

| Carmustine
(BCNU) | 3.3 | 24.3
(25.3,27.4,24 | Moderate
swelling |
|----------------------|-----------|-----------------------|----------------------|
| | | .3) | and no |
| | | | degradation |
| ThioTepa | 10.0 | 48.6 (49.2, | Moderate |
| | | 58.1, 48.6) | swelling |
| | | | and no |
| | | | degradation |
| Fentanyl Citrate | 100mcg/ml | > 240 | Slight |
| | | | swelling |
| | | | and no |
| | | | degradation |
| | | | |
| | | | |

Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

� ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06(2017) Standard Test Method for Residual Powder on Medical Gloves
& ASTM D6319-10 Standard Test Method for Residual Powder on Medical Gloves
& ASTM D6978-2005(2019) Standard Practice for Assessment of Resistances of Medical Gloves to Permeation by Chemotherapy Drugs
& ISO 10993-5 Biological evaluation of medical devices Part 5 Tests for In Vivo Cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 1- Tests for irritation and delayed-type hypersensitivity.

8.0 Clinical Performance Data

Not needed.

9.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.