The Black Colored, Power 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. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
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) 3.3mg.ml 54.1 (minutes)
*Thiotepa 10.0 mg/ml 6.0 (minutes)
*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.
Tested Fentanyl Citrate is as follows: Fentanyl Citrate Injection 100.0 mcg/2ml Average Breakthrough Detection Time (minutes) >= 240

Device Description

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

AI/ML Overview

This document describes the premarket notification (510(k)) for Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. This is a medical device, and the acceptance criteria and study proving it meets these criteria are based on non-clinical performance standards rather than an AI/human reader study.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally defined by adherence to specific ASTM and ISO standards for examination gloves. The reported device performance is presented in several tables.

Characteristics / Test	Standard / Reference Test Method & Sampling	Acceptance Criteria	Reported Device Performance
Glove Specifications	ASTM D6319-10(2015)
Palm width (XS)		75 ± 5 mm	Not explicitly stated for the final product, but implied to meet this standard
Palm width (S)		85 ± 5 mm
Palm width (M)		95 ± 5 mm
Palm width (L)		105 ± 5 mm
Palm width (XL)		115 ± 5 mm
Length		Min 240 mm	Min 240 mm (Table 6)
Thickness (Palm/Finger)		Min 0.05 mm	Min 0.05 mm (Table 6)
Physical Properties		Meets (ASTM D6319-10(2015))	Meets (Table 2)
Powder Content	ASTM D6124-06(2011)	Meets (ASTM D6124-06(2011))	Meets / 0.50 mg/glove (Table 2, Table 6)
Chemotherapy Drugs Permeation	ASTM D6978-2005 (Reapproved 2019)	Minimum Breakthrough Detection Time (minutes)	Minimum Breakthrough Detection Time (minutes) - Device Performance
Cisplatin 1.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Cyclophosphamide (Cytoxan) 20 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Dacarbazine (DTIC) 10.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Doxorubicin Hydrochloride 2.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Etoposide (Toposar) 20.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Fluorouracil 50.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Paclitaxel (Taxol) 6.0 mg/ml		≥ 240	≥ 240 (Table 3, Table 7)
Carmustine (BCNU) 3.3 mg/ml		No explicit threshold given in acceptance criteria, but predicate had 10.1 min	54.1 (Table 3, Table 7), with caution statement
Thiotepa 10.0 mg/ml		No explicit threshold given in acceptance criteria, but predicate had 30.2 min	16.0 (Table 3, Table 7), with warning statement
Fentanyl Citrate Permeation	ASTM D6978-2005 (Reapproved 2019)
Fentanyl Citrate Injection 100.0 mcg/2ml		≥ 240	≥ 240 (Table 3, Table 8)
Biocompatibility	ISO 10993-10: 2010 (Irritation & Sensitization)	Non-irritating and non-sensitization	Non-irritating and non-sensitization (Table 2)
	ISO 10993-5: 2009 (Cytotoxicity)	Non-cytotoxic	Non-cytotoxic (Table 2)
Watertight	21 CFR 800.20, ASTM D5151	Passes	Passes (Table 2)
Dimension (QA Test)	ASTM D6319-10(2015), ANSI/ASQC 21.4-2003	Meet Acceptance Number (AQL 4.0, S-2)	Implied by "Meet Acceptance Number" column in Table 3
Tensile strength & Ultimate elongation (QA Test)	ASTM D6319-10(2015), ANSI/ASQC 21.4-2003	Meet Acceptance Number (AQL 4.0, S-2)	Pass (Minimum 16.44 MPa for Tensile Strength, Minimum 427% for Ultimate Elongation) (Table 5)
Water Leak (QA Test)	FDA 1000ml water leak test method (21CFR 800.20), ANSI/ASQC 21.4-2003	Meet Acceptance Number (AQL 1.5, G-1)	Pass (No. Of Defective = 0 for Freedom From Holes, tested separately) (Table 5)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Sizes:
- Physical Property Tests (Tensile Strength, Elongation): 13 samples (Table 4, Table 5)
- Freedom From Holes: 80 samples/batch (Table 5)
- Powder Residual Test: 1 sample (Table 6)
- Chemotherapy and Fentanyl Permeation Tests: 3 specimens per drug (e.g., Specimen 1/2/3 in Table 7 and 8)
- Quality Assurance Testing: Batch inspection levels (S-2 for Dimension/Tensile, G-1 for Water Leak). The AQL (Acceptable Quality Level) values (4.0 or 1.5) and inspection levels indicate a sampling plan from production lots, not a fixed pre-defined test set.
Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the submitter (Comfort Rubber Gloves Industries Sdn. Bhd.) is located in Malaysia, it is highly probable that the testing was conducted in Malaysia or a recognized testing facility accessible to them. The tests are non-clinical (laboratory/material tests), so the "prospective/retrospective" distinction isn't typically applied as it would be for a clinical study with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a physical medical glove and the acceptance criteria are based on objective, quantifiable physical and chemical properties measured according to established international standards (ASTM, ISO, FDA methods). Therefore, the "ground truth" is established by these laboratory tests and their measurement results, not by expert consensus or interpretation as would be the case for diagnostic imaging AI. No interpretation by medical experts (like radiologists) is relevant for establishing the "ground truth" for glove performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI/diagnostic device that relies on human interpretation or adjudication for its "ground truth." The tests are laboratory-based with objective metrics.

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

Not applicable. This is a physical medical device (examination gloves), not a diagnostic AI system or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.

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

Not applicable. This is a physical medical device, not an algorithm. The performance evaluation is solely based on its physical and chemical properties as measured in a lab, which is "standalone" in the sense that no human-in-the-loop interaction is required for the device's function or evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through:

Adherence to Established Standards: ASTM (American Society for Testing and Materials) standards for physical properties of medical gloves (e.g., D6319 for dimensions, tensile strength, elongation; D6124 for powder residue; D5151 for holes), and D6978 for chemotherapy drug permeation.
International Organization for Standardization (ISO) Standards: ISO 10993 for biocompatibility (irritation, sensitization, cytotoxicity).
FDA Test Methods: Specifically, the FDA 1000ml water leak test method (21 CFR 800.20).
Objective Laboratory Measurements: The numerical results from these tests (e.g., tensile strength in MPa, elongation in %, breakthrough detection time in minutes, powder content in mg/glove).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "device" itself is manufactured and tested according to engineering and material science principles.

9. How the ground truth for the training set was established

Not applicable, as no training set exists for this type of device.

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 29, 2022

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

Re: K200181

Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, 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

Dear Ng 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 April 15, 2020. Specifically, FDA is updating this SE Letter for a typographical error contained in the Indications for Use, 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 the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized graphic of a human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 15, 2020

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

Re: K200181

Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, 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 Dated: January 22, 2020 Received: January 24, 2020

Dear Ng 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/ofdocs/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-reportingcombination-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,

Image /page/2/Picture/5 description: The image shows the name "Elizabeth F. Claverie -S" in a simple, sans-serif font. The text is arranged vertically, with "Elizabeth F." on the first line and "Claverie -S" on the second line. The background is plain white.

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)

K200181

Device Name

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

Indications for Use (Describe)

	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) 3.3mg.ml	54.1 (minutes)
*Thiotepa 10.0 mg/ml	6.0 (minutes)

*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.

Tested Fentanyl Citrate is as follows:	Fentanyl Citrate Injection 100.0 mcg/2ml
Average Breakthrough Detection Time (minutes)	≥ 240

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

K200181

Prepared according to 21 CFR § 807.92 Preparation Date: April 10, 2020

1. Submitter

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

2. Identification of the Device

Device name: Black Colored, Power 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

Regulation: 21 CFR 880.6250

Product code: LZA

Classification Name: Patient Examination Gloves Specialty

Regulation: 21 CFR 880.6250

Product code: LZC

3. Identification of the Legally Marketed Device as Predicate

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.

Predicate 510(K) No.: K183287

4. Description of the Device:

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ReferenceStandard	Glove size	Standard Requirements
		Palm width (mm)	Length (mm)
ASTM 6319	XS	$75 \pm 5$ mm	Min 240
	S	$85 \pm 5$ mm
	M	$95 \pm 5$ mm
	L	$105 \pm 5$ mm
	XL	$115 \pm 5$ mm

Table 1. Glove Specifications for different models

5. Indications for Use

The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are 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. 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.

6. Comparison of the Technological Characteristics between the Subject and Predicate Devices

The Black Colored, Power 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 the predicate.

Characteristics	Standards	Device performance		Remarks
		Predicate device	Subject device
Manufacturer(s)		Kossan International Sdn.Bhd.	Comfort Rubber GlovesIndustries Sdn. Bhd	-
510(k) number		K183287	K200181	-
Indication for Use		A patient examinationglove is a disposable deviceintended for medicalpurpose that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.	The Black Colored, PowerFree Nitrile ExaminationGloves, Non-sterile, andTested for Use withChemotherapy Drugs andFentanyl Citrate is aspecialty medical glovewhich is a disposable deviceintended for medical purposethat is worn on theexaminer's hand or finger toprevent contaminationbetween examiner andpatient. In addition, thesegloves are worn to protectthe wearer against exposureto chemotherapy drugs andFentanyl Citrate. Tested foruse with chemotherapy drugsand Fentanyl Citrate. Testedchemotherapy drugs are asfollows:	Same
		These gloves were testedfor use with chemotherapydrugs and Fentanyl Citrateper ASTM D6978-05(Reapproved 2013)Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs.Minimum BreakthroughDetection Time in minutes





		Carmustine (BCNU)(3.3mg/ml) - 10.1 Cisplatin,(1.0 mg/ml) - >=240
		Cyclophosphamide	Average Breakthrough
		(Cytoxan), 20.0 mg/ml - >=	Detection Time (minutes)
		240 Cytarabine (100 mg/ml)	Cisplatin, 1.0 mg/ml -
		>=240	>=240
		Dacarbazine (DTIC), 10.0	Cyclophosphamide
		mg/ml >=240	(Cytoxan), 20.0 mg/ml
		Doxorubicin Hydrochloride,	->=240
		(2.0 mg/ml) >=240	Dacarbazine (DTIC),
		Etoposide, (20.0 mg/ml)	10.0 mg/ml - >=240
		>=240	Doxorubicin Hydrochloride,
		Fluorouracil, (50.0 mg/ml)	2.0 mg/ml ->=240
		>=240	Etoposide (Toposar), 20.0
		lfosfamide (50.0 mg/ml)	mg/ml ->=240
		>=240	Fluorouracil, 50.0mg/ml -
		Methotrexate (25.0 mg/ml)	>=240
		>=240	Paclitaxel (Taxol), 6.0mg/ml
		Mitomycin C (0.5 mg/ml)	>=240
		>=240	*Carmustine (BCNU)
		Mitoxantrone (2.0 mg/ml)	3.3mg/ml - 54.1 (mins)
		>=240	*Thiotepa 10.0 mg/ml
		Paclitaxel (Taxol), 6.0 mg/ml	- 16.0 (mins)
		>=240	*Please note that these drugs
		Thiotepa (10.0 mg/ml) - 30.2	have extremely low
		Vincristine Sulfate (1.0mg/ml)	permeation time.
		>=240.	CAUTION: Testing showed
		Please note that Carmustine	an average breakthrough
		(BCNU) has extremely low	time of 54.1 minutes with
		permeation time of 10.1	Carmustine; WARNING: Do
		minutes. Fentanyl Citrate and	not use with Thiotepa.
		Concertation Fentanyl Citrate	Tested Fentanyl Citrate is as
		Injection (100.0 mcg/2ml)	follows: Fentanyl Citrate
		Minimum Breakthrough	Injection 100.0 mcg/2ml
		Detection Time in	Average Breakthrough
		minutes>=240	Detection Time
			(minutes) >=240
	ASTM D6319-	Length-Min 240mm	Length-Min 240mm Thickness
Dimension	10(2015)	Thickness palm and finger-	palm and finger- Min 0.05mm	Similar
		Min 0.05mm
Physical Properties	ASTM D6319-	Meets	Meets	Similar
	10(2015)
Thickness - Finger-	ASTM D6319-	Meets	Meets	Similar
Palm	10(2015)
Powder Content	ASTM D6124-	Meets	Meets	Similar
	06(2011)
Chemotherapy	Concentration		Minimum Breakthrough Detection Time (min)
Drugs
Cisolatin	1.0 mg/ml	>240	>240	Same
Cyclophosphamide	20 mg/ml	>240	>240	Same
(Cvtoxan)
Dacarbazine (DTIC)	10.0 mg/ml	>240	>240	Same
Doxorubicin	2 0 mg/ml	>240	>240	Same
Hvdrochloride
Etoooside (Toposar)	20.0 ma/ml	>240	>240	Same
Fluorouracil	50.0 ma/ml	>240	>240	Same
Paclitaxel (Taxol)	6.0 mg/ml	>240	>240	Same
lfosfamide	50.0 ma/ml	>240	-	Different
Mitoxantrone	2.0 mg/ml	>240	-	Different
Vincristine Sulfate	1.0 mg/ml	>240	-	Different
Carmustine (BCNU)	3.3 mg/ml	15.0	54.1	Similar
Thiotepa	10.0 mg/ml	2.0	16.0	Similar
Fentanyl Citrate	100mcq/2ml	-	>240	Different
Biocompatibility	ISO10993-10: 2010Biologicalevaluation ofmedical devices --Part 10: Tests forirritation and skinSensitization	Under the conditions of thestudy, the subject device isnon-irritating	Under the conditions of thestudy, the subject device isnon- irritating	Same
	ISO10993-5: 2009	Under the conditions of thestudy, the subject device isnon- sensitization	Under the conditions of thestudy, the subject device isnon- sensitization	Same
	BiologicalEvaluation ofMedical Devices-Part 5: Test for InVitro Cytotoxicity	Under the conditions of thestudy, the subject device isnon- cytotoxic	Under the conditions of thestudy, the subject device is non-cytotoxic	Same
Watertight (1000ml)	21 CFR 800.20ASTM D5151	Passes	Passes	Same
Material	ASTM 06319 -10(2015)	Nitrile	Nitrite	Same
Color	-	Blue White Black	Black	Same
Size	Medical GloveGuidance Manual- Labeling	Extra smallSmallMediumLargeExtra Large	Extra SmallSmallMediumLargeExtra Large	Same
Single Use	Medical GloveGuidance Manual- Labeling	Single Use	Single Use	Same

Table 2. Comparison of the Technological Characteristics

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The subject device and the predicate device share the same indication for use, same material, same specifications for thickness and length, similar permeation rate for chemotherapy drugs, similar labeling properties, powder free, biocompatibility and water tight test.

7. Summary of Non-Clinical tests

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

ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic . Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber- Deterioration . in an Air Oven
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in . Medical Gloves
ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on ● Medical Gloves
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical ● Application
ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance . of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes ●
ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity ●

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ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and . delayed-type hypersensitivity

Characteristics	Reference Test Method &Sampling	Inspection Level	AQL	Acceptance Criteria
Dimension (length, width, thickness)	ASTM D6319 - 10(2015)ANSI / ASQC 21.4-2003	S-2	4.0	Meet Acceptance Number
Tensile strength andUltimate elongation	ASTM D 6319 - 10(2015)ANSI / ASQC 21.4-2003	S-2	4.0	Meet Acceptance Number
Water Leak	FDA 1000ml water leak test method(21CFR 800.20)ANSI / ASQC 21.4-2003	G-1	1.5	Meet Acceptance Number
Powder Residue	ASTM D6124 - 06(2011)	N/A	N/A	2 mg/glove

Table 3. Quality Assurance Testing For Finished Gloves

Table 4. Physical Property

Sample	Unaged		Aged (7 Days, 70°C)
	Tensile Strength(MPA)	Elongation AtBreak (%)	Tensile Strength(MPA)	Elongation At Break(%)
1	22.86	596	20.80	447
2	15.32	520	19.73	462
3	16.79	523	24.81	518
4	15.81	575	20.49	459
5	23.60	585	24.92	518
6	22.00	550	20.49	487
7	21.36	531	20.94	475
8	20.78	637	20.47	499
9	22.95	602	19.03	459
10	22.11	541	24.29	493
11	21.23	615	16.44	427
12	20.43	552	19.88	466
13	22.84	633	19.13	487
Mean	21.36	585	20.49	475
Minimum	15.32	520	16.44	427

Table 5. Freedom From Holes

Test	Number Tested/Batch	Results
Tensile Strength	13	Pass (Minimum 16.44 MPa)
Ultimate Elongation	13	Pass (Minimum 427 %)
Freedom From Holes	80	Pass (No. Of Defective = 0)

No	Sample	Size	Length(mm)	Weight ofFilter+DriedResidue (A)	Weight ofFilter (B)	Weight ofH20 +DriedResidue (C)	A-B-CX 1000(mg)	ResidualPowderContent(mg/glove)
1	Lot No.81107F50510	M	240	0.0970	0.0945	0.0000	2.5	0.50

Table 6. Powder Residual Test Result

{9}------------------------------------------------

Test Chemotherapy Drugs	Minimum BreakthroughDetection Time(Specimen 1/2/3) (Minutes)	Steady State Perm. Rate(Specimen 1/2/3)(µg/Cm2/Minute)	OtherObservations
Carmustine (BCNU),3.3 mg/ml (3,300ppm)	54.1(56.4, 54.1, 56.7)	0.6(0.6, 0.6, 0.6)	Moderate swellingand slightdegradation
Cisplatin,1.0 mg/ml (1,000 ppm)	>240	N/A	No significantchanges
Cyclophosphamide(Cytoxan), 20 mg/ml(20,000 ppm)	>240	N/A	No significantchanges
Dacarbazine,10 mg/ml (10,000 ppm)	>240	N/A	No significantchanges
Doxorubicin Hydrochloride,2.0 mg/ml (2,000 ppm)	>240	N/A	No significantchanges
Etoposide (Toposar),20.0 mg/ml (20 000 ppm)	>240	N/A	No significantchanges
Fluorouracil,50 mg/ml (50,000ppm)	>240	N/A	No significantchanges
Paclitaxel (Taxol),6.0 mg/ml (6,000ppm)	>240	N/A	Slight swellingand nodegradation
Thiotepa (THT),10 mg/ml (10,000ppm)	16.0(16.0,26.8,17.7)	0.4(0.5,0.3,0.4)	No significantchanges

Table 7. Chemotherapy Drug Permeation Test Results

Table 8. Fentanyl Drug Permeation Test Result

Test Drug AndConcentration	Minimum BreakthroughDetection Time(Specimen 1/2/3) (Minutes)	Steady State Perm. Rate(Specimen 1/2/3)(µg/Cm2/Minute)	OtherObservations
Fentanyl Citrate Injection,100mcg/2mL	>240	N/A	Slight swelling; nodegradation

8. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device, the Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under 510(K) submission K183287.

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.