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.

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.

AI/ML Overview

This document pertains to the 510(k) premarket notification for "Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K192954). The information provided is primarily focused on the non-clinical performance data of these gloves, specifically their resistance to permeation by chemotherapy drugs and fentanyl citrate, as well as their general physical properties and biocompatibility.

The request asks for information relevant to the acceptance criteria and study proving a device meets acceptance criteria, typically in the context of an AI/ML medical device. The provided document is for a physical medical device (examination gloves) and not an AI/ML-driven device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and how the performance of these gloves was evaluated based on the provided text.

Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)

The device performance was evaluated against established industry standards for examination gloves. The primary performance criteria highlighted are related to the permeation of chemotherapy drugs and fentanyl citrate, as well as general physical characteristics and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Test	Standard / Methodology	Acceptance Criteria	Reported Device Performance	Comparison / Notes
Physical Properties	ASTM D412-2016	Tensile Strength (Min 14 MPa), Elongation (Min 400%)	Pass	Similar to predicate, meets standard.
Water Leak Test	ASTM D5151-2006	AQL 1.5 (ISO 2859-1)	Pass	Same as predicate, meets standard.
Powder Residue	ASTM D6124-2006	Max 2 mg/glove	Pass	Similar to predicate, meets standard.
Chemotherapy Drug Permeation (Individual Drugs)	ASTM D6978-2005	≥ 240 minutes (for most drugs)	Cisplatin: ≥ 240 min Cyclophosphamide (Cytoxan): ≥ 240 min Dacarbazine (DTIC): ≥ 240 min Doxorubicin Hydrochloride: ≥ 240 min Etoposide (Toposar): ≥ 240 min Fluorouracil: ≥ 240 min Paclitaxel (Taxol): ≥ 240 min Carmustine (BCNU): 18.2 min Thiotepa (THT): 57.3 min	For most drugs, the acceptance criteria was met or exceeded. Carmustine and Thiotepa had significantly lower breakthrough times, leading to specific warnings. The reported times for these two drugs were slightly higher than the predicate's reported times (15 min and 2 min, respectively), indicating a marginal improvement for the subject device.
Fentanyl Citrate Permeation	ASTM D6978-2005	≥ 240 minutes	≥ 240 minutes	Meets acceptance criteria.
Biocompatibility - Primary Skin Irritation	ISO 10993-10:2010	Non-irritating	Passes: Non-irritating	Same as predicate, meets standard.
Biocompatibility - Dermal Sensitization	ISO 10993-10:2010	Non-sensitization	Passes: Non-sensitization	Same as predicate, meets standard.
Biocompatibility - Cytotoxicity	ISO 10993-5:2009	Cytotoxicity reactivity defined (not a simple pass/fail, depends on concentration)	Exhibits severe cytotoxicity reactivity at 100% and 66% extract concentrations and no cytotoxicity reactivity at 44%, 30%, 20%, and 15% extract concentrations.	Different from predicate (-), which implies the predicate either wasn't tested or had different results for cytotoxicity. The specific "acceptance criteria" isn't strictly a "pass" result in all concentrations but rather a characterization of the reactivity.
Biocompatibility - Acute Systemic Toxicity	ISO 10993-11:2017	No adverse biological reaction	Passes: No adverse biological reaction.	Different from predicate (-), implying the predicate either wasn't tested or had different results for acute systemic toxicity.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., number of gloves tested for permeation, water leak, or biocompatibility). The results are presented as "Pass" or average breakthrough times, which implies testing was conducted on a sufficient number of samples according to the respective ASTM/ISO standards.
Data Provenance: The device manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., is located in Matang, Perak, Malaysia. The tests were conducted according to international standards (ASTM, ISO), but the specific laboratory location is not detailed. The data is non-clinical performance data, generated from laboratory testing, not human patient data (retrospective/prospective healthcare records).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as the document describes a physical medical device (gloves) and their material/chemical resistance testing, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or data. Performance is determined by established engineering and chemical testing standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as above. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert consensus for AI/ML performance evaluation, not for laboratory testing of a physical product's material properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/ML-driven device or an AI-assisted human reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as this is not an algorithm or AI-driven device. The "standalone" performance refers to the intrinsic properties of the glove material against chemical permeation and physical stress.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by well-defined, internationally recognized laboratory testing standards and methods (e.g., ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151 for water leak, ISO 10993 for biocompatibility). These standards specify the experimental procedures and often the criteria for "pass" or "fail" for the material properties of the gloves. The "truth" is based on the physical and chemical behavior observed under these controlled experimental conditions.

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/ML device. There is no "training set" in the context of device performance, but rather test samples used for validation against defined standards.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as above.

Summary

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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

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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

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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

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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)

	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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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:

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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.

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Table 1

Technological Characteristic Comparison Table

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
Manufacturer(s)		Kossan InternationalSdn. Bhd.	Comfort Rubber GlovesIndustries Sdn. Bhd	Different
510(k) number		K183287	K192954
Dimension	ASTM D6319 -10(2015)	Length-Min 240mmThickness palm andfinger- Min 0.05mm	Length-Min 240mmThickness palm andfinger- 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 withChemotherapy Drugs and Fentanyl Citrate
ChemotherapyDrugPermeation Test	ASTM D6978-05
TestDrug	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
DoxorubicinHydrochloride		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 thefollowing drugs haveextremely low permeationtimes Carmustine(BCNU): 15 minutes andThiotepa : 2 minutes.	* WARNING :Please note that thefollowing drugs haveextremely low permeationtimes Carmustine (BCNU):18.2 minutes andThiotepa : 57.3 minutes.	Similar - Thechemotherapydrugs testedhave similarbreakthroughdetectiontimes; thedrugs with lowpermeationtimes are thesame.

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

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
Biocompatibility	Primary Skin IrritationISO 10993-10:2010Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization	PassesUnder the conditions of the study, the subject device is non-irritating	PassesUnder the conditions of the study, the subject device is non-irritating	Same
	Dermal SensitizationISO 10993-10:2010Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization	PassesUnder the conditions of the study, the subject device is non-sensitization	PassesUnder the conditions of the study, the subject device is non-sensitization	Same
	CytotoxicityISO 10993-5:2009Biological 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 studyISO 10993-11: 2017Biological evaluation of medical devices -Part 11: Tests for systemic toxicity	-	PassesUnder the conditions of the study, the subject showed no adverse biological reaction.	-Different
Watertight (1000ml)	21 CFR 800.20ASTM 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

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

chemotherapy drugsand Fentanyl Citrateper ASTM D6978-05(Reapproved 2013)Standard Practice forAssessment of MedicalGloves to Permeationby ChemotherapyDrugs.Minimum BreakthroughDetection Time inminutesCarmustine (BCNU)(3.3mg/ml) - 10.1Cisplatin, (1.0 mg/ml) -≥ 240Cyclophosphamide(Cytoxan), 20.0 mg/ml- ≥ 240Cytarabine (100mg/ml) - ≥ 240Dacarbazine (DTIC),10.0 mg/ml - ≥ 240DoxorubicinHydrochloride, (2.0mg/ml) - ≥ 240Etoposide, (20.0mg/ml) - ≥ 240Fluorouracil, (50.0mg/ml) - ≥ 240Ifosfamide (50.0mg/ml) ≥ 240Methotrexate (25.0mg/ml) ≥ 240Mitomycin C (0.5mg/ml) ≥ 240Mitoxantrone (2.0mg/ml) ≥ 240Paclitaxel (Taxol), 6.0mg/ml- ≥ 240Thiotepa (10.0 mg/ml)- 30.2Vincristine Sulfate (1.0mg/ml) ≥ 240.Please note thatCarmustine (BCNU)has extremely lowpermeation time of10.1 minutes.Fentanyl Citrate andConcertationFentanyl CitrateInjection (100.0mcg/2ml)	purpose that is wornon the examiner'shand or finger toprevent contaminationbetween examiner andpatient. In addition,these gloves are wornto protect the weareragainst exposure tochemotherapy drugsand Fentanyl Citrate.Tested for use withchemotherapy drugsand Fentanyl Citrate.Tested chemotherapydrugs are as follows:Average BreakthroughDetection Time(minutes)Cisplatin 1.0 mg/ml ≥240Cyclophosphamide(Cytoxan) 20 mg/ml ≥240Dacarbazine (DTIC)10.0 mg/ml ≥ 240DoxorubicinHydrochloride 2.0mg/ml ≥ 240Etoposide (Toposar)20.0 mg/ml ≥ 240Fluorouracil 50.0mg/ml ≥ 240Paclitaxel (Taxol) 6.0mg/ml ≥ 240The glove was testedfor use withChemotherapy Drugsand Fentanyl Citrate asper ASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeationby ChemotherapyDrugs. Please notethat the following drugshave extremely lowpermeation times:Carmustine (BCNU):18.2 minutes andThiotepa: 57.3minutes. Warning: Donot use withCarmustine.			Minimum BreakthroughDetection Time inminutes ≥ 240
Material	ASTM D6319 -10(2015)	Nitrile	Nitrile	Same
Color	-	BlueWhiteBlack	Blue	Same
Size	Medical GloveGuidance Manual- Labeling	Extra SmallSmallMediumLargeExtra Large	Extra SmallSmallMediumLargeExtra Large	Same
Single Use	Medical GloveGuidance Manual- Labeling	Single Use	Single Use	Same

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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) andElongation (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 byChemotherapy Drugs	≥ 240 minutes	Pass
ISO 10993-10	Irritation and delayed-type hypersensitivity	Skin sensitization andSkin irritation	The subject device isnon-sensitization andNon-irritation
ISO 10993-5	Cytotoxicity	Cytotoxicity reactivity	Exhibits severecytotoxicity reactivity at100%, and 66% extractconcentrations and nocytotoxicity reactivity at44%, 30%, 20% and15% extractconcentrations underthe condition of thistest.
ISO 10993-1:2018	Acute systemic toxicitystudy	Subject showed no adverse biological reaction	No adverse biologicalreaction.

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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.

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.