Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the summary focuses on material properties and performance against standards, with no mention of AI or ML.

Therapeutic

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

Diagnostic

No

This device, Nitrile Examination Gloves, is intended to prevent contamination between examiner and patient, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, not a software application. The description focuses on material properties and performance standards for a physical product.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is a "patient medical exam glove" worn on the hand or finger to prevent contamination between examiner and patient. This is a barrier device for physical protection.
IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis on biological specimens.
Device Description: The description focuses on the physical properties and standards met for a medical glove.
Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.

The testing for chemotherapy drugs and fentanyl citrate permeation relates to the glove's barrier properties and safety for the user and patient in specific medical scenarios, not to the diagnosis of a condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam 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 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, QDO

Device Description

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

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 professional), 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.

Study Type: Non-clinical Performance Testing
Sample Size: Not specified
Key Results: The device passed tests for:

Physical Properties (ASTM D412-2016): Tensile Strength (Min 14 Mpa) and Elongation (Min 400%)
Water leak test (ASTM D5151-2006): AQL 1.5 (ISO 2859-1)
Powder Residue (ASTM D6124-2006): Max 2mg/glove
Permeation by Chemotherapy Drugs (ASTM D6978-2005): >= 240 minutes
Irritation and delayed-type hypersensitivity (ISO 10993-10): Non-sensitization and Non-irritation
Cytotoxicity (ISO 10993-5): Exhibits severe cytotoxicity reactivity at 100%, and 66% extract concentrations and no cytotoxicity reactivity at 44%, 30%, 20% and 15% extract concentrations
Acute systemic toxicity study (ISO 10993-1:2018): No adverse biological reaction.

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

Tensile Strength: Min 14 Mpa
Elongation: Min 400%
Water leak test AQL: 1.5 (ISO 2859-1)
Powder Residue: Max 2mg/glove
Permeation by Chemotherapy Drugs: ≥ 240 minutes (for most tested drugs, with specific exceptions for Carmustine and Thiotepa)
Carmustine (BCNU) average breakthrough detection time: 18.2 minutes
Thiotepa (THT) average breakthrough detection time: 57.3 minutes

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

K183287

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

Not Found

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

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

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

August 24, 2022

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe QA Manager Lot 821, Jalan Matang Matang, 34750 Malaysia

Re: K192954

Trade/Device Name: Blue Colored, Power Free Nitrile Examination Gloves 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, QDO

Dear Ng Kok Howe:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 19, 2020. Specifically, FDA is updating this SE Letter for a typographical error contained in the Indications for Use and 510(k) Summary, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, Office of Surgical and Infection Control Devices, at: (301) 796-2261 or bifeng.qian@fda.hhs.gov.

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

1

Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 19, 2020

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe QA Manager Lot 821, Jalan Matang Matang, 34750 My

Re: K192954

Trade/Device Name: Blue Colored, Power Free Nitrile Examination Gloves 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, QDO, Dated: November 29, 2019 Received: May 11, 2020

Dear Ng Kok Howe:

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.

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

2

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-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Elizabeth F. Claverie -S

CAPT Elizabeth Claverie, M.S. 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

3

Indications for Use

510(k) Number (if known) K192954

Device Name

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

Indications for Use (Describe)

The Blue Colored, Powder Free Nittrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a patient medical exam 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 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:	Average Breakthrough Detection Time (minutes)
	Cisplatin 1.0 mg/ml	≥ 240
	Cyclophosphamide (Cytoxan) 20 mg/ml	≥ 240
	Dacarbazine (DTIC) 10.0 mg/ml	≥ 240
	Doxorubicin Hydrochloride 2.0 mg/ml	≥ 240
	Etoposide (Toposar) 20.0 mg/ml	≥ 240
	Fluorouracil 50.0 mg/ml	≥ 240
	Paclitaxel (Taxol) 6.0 mg/ml	≥ 240
	Carmustine (BCNU) -3.3 mg/ml	18.2
	Thiotepa (THT) -10.0 mg/ml	57.3
	Tested Fentanyl Citrate is as follows:
Fentanyl Citrate Injection 100.0 mcg/2ml	Average Breakthrough Detection Time (minutes) ≥ 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.

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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4

510(k) SUMMARY - K192954

1.0 Submitter :

Name	: Comfort Rubber Gloves Industries Sdn. Bhd.
Address	: Lot 821, Jalan Matang,
34750 Matang, Perak, Malaysia.
Malaysia.
Phone No.	: 605-847 2777
Fax No.	: 605-847 9108
Contact Person	: Ng Kok Howe (Mr.)

Date of Preparation : June 10, 2020

2.0 Name of the Device

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

Common Name :	Patient Examination Gloves
Classification Name :	Patient Examination Gloves (21 CFR 880.6250 )
Patient Examination Gloves Specialty (21 CFR 880.6250
510(K) Number :	K192954
Device Class :	I
Product code :	LZA, LZC, QDO

3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

Device Name : Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Company : Kossan International Sdn. Bhd.

510(K) No. : K183287

4.0 Description of the Device:

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319 -10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

5

5.0 Indication for Use of the Device

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 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:

	Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml	≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml	≥ 240
Dacarbazine (DTIC) 10.0 mg/ml	≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml	≥ 240
Etoposide (Toposar) 20.0 mg/ml	≥ 240
Fluorouracil 50.0 mg/ml	≥ 240
Paclitaxel (Taxol) 6.0 mg/ml	≥ 240
Carmustine (BCNU) -3.3 mg/ml	18.2
Thiotepa (THT) -10.0 mg/ml	57.3

Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time (minutes) Fentanyl Citrate Injection 100.0 mcg/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.

6.0 Summary of the Technological Characteristics of the Device:

The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.

Chemotherapy claim is similar to Predicate, which has a gloves thickness comply with the ASTM Standards.

6

Table 1

Technological Characteristic Comparison Table

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Manufacturer(s)		Kossan International
Sdn. Bhd.	Comfort Rubber Gloves
Industries Sdn. Bhd	Different
510(k) number		K183287	K192954
Dimension	ASTM D6319 -
10(2015)	Length-Min 240mm
Thickness palm and
finger- Min 0.05mm	Length-Min 240mm
Thickness palm and
finger- Min 0.05mm	Similar
Physical Properties	ASTM D6319 -
10(2015)	Meets	Meets	Similar
Thickness – Finger

Palm | ASTM D6319 -
10(2015) | Meets | Meets | Similar |
| Powder Content | ASTM D6124 -
06(2011)
(≤ 2 mg/glove) | Meets | Meets | Similar |

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate
Chemotherapy
Drug
Permeation Test	ASTM D6978-05
Test
Drug	Chemotherapy	Concentration	Minimum Breakthrough Detection Time (min)
Cisplatin		1.0 mg/ml	>240	>240
Cyclophosphamide
(Cytoxan)		20 mg/ml	>240	>240
Dacarbazine (DTIC)		10.0 mg/ml	>240	>240
Doxorubicin
Hydrochloride		2.0 mg/ml	>240	>240
Etoposide (Toposar)		20.0 mg/ml	>240	>240
Fluorouracil		50.0 mg/ml	>240	>240
Paclitaxel (Taxol)		6.0 mg/ml	>240	>240
Ifosfamide		50.0 mg/ml	>240	-
Mitoxantrone		2.0 mg/ml	>240	-
Vincristine Sulfate		1.0 mg/ml	>240	-
*Carmustine (BCNU)		3.3 mg/ml	15.0	18.2
*Thiotepa		10.0 mg/ml	2.0	57.3
Fentanyl Citrate Injection		100mcg/2ml	-	>240
Warning Statement		* WARNING :
Please note that the
following drugs have
extremely low permeation
times Carmustine
(BCNU): 15 minutes and
Thiotepa : 2 minutes.	* WARNING :
Please note that the
following drugs have
extremely low permeation
times Carmustine (BCNU):
18.2 minutes and
Thiotepa : 57.3 minutes.	Similar - The
chemotherapy
drugs tested
have similar
breakthrough
detection
times; the
drugs with low
permeation
times are the
same.

7

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

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Biocompatibility	Primary Skin Irritation
ISO 10993-10:2010
Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization	Passes
Under the conditions of the study, the subject device is non-irritating	Passes
Under the conditions of the study, the subject device is non-irritating	Same
	Dermal Sensitization
ISO 10993-10:2010
Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization	Passes
Under the conditions of the study, the subject device is non-sensitization	Passes
Under the conditions of the study, the subject device is non-sensitization	Same
	Cytotoxicity
ISO 10993-5:2009
Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity	-	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.	-Different
	Acute systemic toxicity study
ISO 10993-11: 2017
Biological evaluation of medical devices -
Part 11: Tests for systemic toxicity	-	Passes
Under the conditions of the study, the subject showed no adverse biological reaction.	-Different
Watertight (1000ml)	21 CFR 800.20
ASTM D5151	Passes	Passes	Same
Indication for Use		A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were	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	Similar

8

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

| chemotherapy drugs
and Fentanyl Citrate
per ASTM D6978-05
(Reapproved 2013)
Standard Practice for
Assessment of Medical
Gloves to Permeation
by Chemotherapy
Drugs.
Minimum Breakthrough
Detection Time in
minutes
Carmustine (BCNU)
(3.3mg/ml) - 10.1
Cisplatin, (1.0 mg/ml) -
≥ 240
Cyclophosphamide
(Cytoxan), 20.0 mg/ml

≥ 240
Cytarabine (100
mg/ml) - ≥ 240
Dacarbazine (DTIC),
10.0 mg/ml - ≥ 240
Doxorubicin
Hydrochloride, (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 (Taxol), 6.0
mg/ml
≥ 240
Thiotepa (10.0 mg/ml)
30.2
Vincristine Sulfate (1.0
mg/ml) ≥ 240.
Please note that
Carmustine (BCNU)
has extremely low
permeation time of
10.1 minutes.
Fentanyl Citrate and
Concertation
Fentanyl Citrate
Injection (100.0
mcg/2ml) | purpose that is worn
on the examiner's
hand or finger to
prevent contamination
between examiner and
patient. In addition,
these gloves are worn
to protect the wearer
against exposure to
chemotherapy drugs
and Fentanyl Citrate.
Tested for use with
chemotherapy drugs
and Fentanyl Citrate.
Tested chemotherapy
drugs are as follows:
Average Breakthrough
Detection Time
(minutes)
Cisplatin 1.0 mg/ml ≥
240
Cyclophosphamide
(Cytoxan) 20 mg/ml ≥
240
Dacarbazine (DTIC)
10.0 mg/ml ≥ 240
Doxorubicin
Hydrochloride 2.0
mg/ml ≥ 240
Etoposide (Toposar)
20.0 mg/ml ≥ 240
Fluorouracil 50.0
mg/ml ≥ 240
Paclitaxel (Taxol) 6.0
mg/ml ≥ 240
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. 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. | | | Minimum Breakthrough
Detection Time in
minutes ≥ 240 | Tested Fentanyl
Citrate is as follows:
Average
Breakthrough
Detection Time
(minutes)
Fentanyl Citrate
Injection 100.0
mcg/2ml ≥ 240 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Material | ASTM D6319 -
10(2015) | Nitrile | Nitrile | Same | | |
| Color | - | Blue
White
Black | Blue | Same | | |
| Size | Medical Glove
Guidance Manual
Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same | | |
| Single Use | Medical Glove
Guidance Manual
Labeling | Single Use | Single Use | Same | | |

9

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

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 results demonstrated that the proposed device met the performance criteria with the following standards:

Methodology	Purpose	Acceptance Criteria	Results
ASTM D412-2016	Physical Properties	Tensile Strength (Min 14 Mpa) and
Elongation (Min 400%)	Pass
ASTM D5151-2006	Water leak test	AQL 1.5 (ISO 2859-1)	Pass
ASTM D6124-2006	Powder Residue	Max 2mg/glove	Pass
ASTM D6978-2005	Permeation by
Chemotherapy Drugs	≥ 240 minutes	Pass
ISO 10993-10	Irritation and delayed-
type hypersensitivity	Skin sensitization and
Skin irritation	The subject device is
non-sensitization and
Non-irritation
ISO 10993-5	Cytotoxicity	Cytotoxicity reactivity	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.
ISO 10993-1:2018	Acute systemic toxicity
study	Subject showed no adverse biological reaction	No adverse biological
reaction.

10

ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic o Elastomers-Tension
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes o in Medical Gloves
O ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on Medical Gloves
o ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of O Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo o cytotoxicity
ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and O delayed-type hypersensitivity

8.0 Clinical Performance Data

Clinical data is not needed.

9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device.