A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. 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:

Test Chemotherapy drug & Concentration	Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU)(3.3 mg/ml)	12.1 min.
Cyclophosphamide (Cytoxan) (20.0 mg/ml)	>240 min.
Doxorubicin Hydrichloride (2.0mg/)	>240 min.
Etoposide (Toposar) (20.0mg/ml)	>240 min.
Fluorouracil (50.0mg/ml)	>240 min.
Methotrexate (25.0 mg/ml)	>240 min.
Paclitaxel (Taxol) (6.0 mg/ml)	>240 min.
Thiotepa(10.0 mg/ml)	10.1 min.
Vincristine Sulfate(1.0 mg/ml)	>240 min.
Cisplatin(1.0 mg/ml)	>240 min.
Dacarbazine(10 mg/ml)	>240 min.
Mitomycin C(0.5 mg/ml)	>240 min.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.

Warning: Do not use with Carmustine or Thiotepa

Fentanyl Citrate & Concentration	Minimum Breakthrough Detection Times
Fentanyl Citrate Injection(100 mcg/2ml)	>240 min.

Device Description

The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:

Ambidextrous with beaded cuff and straight fingers
Finger-textured,
Blue colored
Containing Hyaluronic Acid coating.
Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
Tested against chemotherapy drugs and fentanyl citrate.

The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (nitrile patient examination gloves with hyaluronic acid) and details the performance testing against established standards.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

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

The document includes a "Technological Characteristics Comparison Table" (pages 7-9) that serves this purpose. It compares the applicant's device to a predicate device (K200671). The "Acceptance Criteria" column effectively outlines the criteria, and the "Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves..." column shows the reported device performance.

Characteristics	Acceptance Criteria (from predicate/standards)	Reported Device Performance (Anhui Intco Medical Products Co., Ltd.)	Comparison Conclusions
Product Code	LZA, LZC, OPJ, QDO	LZA, LZC, OPJ, QDO	(Implicitly "Same")
Intended use	A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05.	A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. 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.	Same
Material used	Nitrile	Nitrile	Identical
Color	Blue	Blue	Same
Single use	Single Use	Yes	Same
Non Sterile	Non Sterile	Non Sterile	Same
Other	(Implicit: Additives related to coating)	Hyaluronic Acid coated on the donning surface	Different(1)
Dimensions	Overall Length (mm): For XS, S, Min 220mm; For M,L,XL,XXL Min 230mm. Width (± 10mm): XS=70mm, S=80mm, M=95mm, L=110mm, XL=120mm, XXL=130mm. Thickness at Palm (mm) Min: 0.05mm. Thickness at Finger Tip (mm) Min: 0.05mm.	Complies with ASTM D6319-19: X Small 70±10, Small 80 ±10, Medium 95±10, Large 110 ±10, X large 120 ±10, XX Large 130 ±10. Thickness: Palm - 0.05mm min., Finger - 0.05 mm min.	Similar
Physical properties	Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500min. After Aging: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min.	Meets ASTM D6319-19: Tensile Strength: Before Aging 14 MPa, min. After Aging 14 MPa, min. Elongation: Before Aging 500% min. After Aging 400% min.	Meets the criteria
Freedom from pinholes	AQL 2.5, Inspection Level G-1	In accordance with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5	Meets the criteria
Residual Powder	Less than 2mg per glove ASTM D 6124-06	Average powder residue < 2mg per glove	Meets the criteria
Primary Skin Irritation Test	ISO10993-10:2010	Under the conditions of this study, the test article was a non-irritant.	Same
Dermal Sensitization Assay	ISO10993-10:2010	Under the conditions of this study, the test article was a non-sensitizer.	Same
Acute systemic toxicity	ISO 10993-11:2017	Under the conditions of this study, No evidence of acute systemic toxicity	Same
Resistance against Chemotherapy Drugs	Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASTM D6978-05(2013)	1) Carmustine (BCNU) (3.3 mg/ml), Breakthrough time: 12.1 min.2) Cyclophosphamide (Cytoxan), (20.0 mg/ml), Breakthrough time: >240 min.3) Doxorubicin Hydrochloride (2.0mg/), Breakthrough time: >240 min.4) Etoposide (Toposar) (20.0mg/ml), Breakthrough time: >240 min.5) Fluorouracil (50.0mg/ml), Breakthrough time:>240 min.6) Methotrexate (25.0 mg/ml), Breakthrough time: >240 min.7) Paclitaxel (Taxol) (6.0 mg/ml), Breakthrough time: >240 min.8) Thiotepa, Breakthrough time: 10.1 min.9) Vincristine Sulfate (1.0 mg/ml), Breakthrough time:>240 min.10) Cisplatin (1.0 mg/ml), Breakthrough time:>240 min.11) Dacarbazine (10 mg/ml), Breakthrough time:>240 min.12) Mitomycin C (0.5 mg/ml), Breakthrough time:>240 min.13) Fentanyl Citrate Injection (100 mcg/2ml), Breakthrough time:>240 min.	Similar

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the test sets in the non-clinical tests (e.g., how many gloves were tested for pinholes, how many animals were used for biocompatibility testing). However, it refers to industry standards like ASTM and ISO, which typically define appropriate sample sizes for such tests.

Provenance: The tests were performed in accordance with international standards (ASTM, ISO). The manufacturing company is Anhui Intco Medical Products Co., Ltd. located in Anhui, China. The testing itself is presented as non-clinical testing to demonstrate performance against these standards. The testing format suggests a retrospective evaluation against pre-defined performance criteria.

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 information is not applicable as the document describes performance testing of physical characteristics of gloves against codified standards (ASTM, ISO), not an AI device or a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the pass/fail criteria defined by the standards.

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

This is not applicable as the document describes performance testing of physical characteristics against codified standards. There is no subjective adjudication process for the test results.

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 is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a medical glove, not an algorithm.

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

The "ground truth" for the performance tests conducted (e.g., tensile strength, pinholes, chemical permeation, biocompatibility) is established by industry standards and test methods (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05, ISO 10993 series). These standards define the acceptable range or threshold for a given characteristic to be considered compliant.

8. The sample size for the training set:

This is not applicable. The device is a medical glove, not an AI model that requires a training set.

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

This is not applicable.

Summary

{0}------------------------------------------------

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

March 1, 2024

Anhui Intco Medical Products Co., Ltd % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave Ontario, California 91764

Re: K231365

Trade/Device Name: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: January 3, 2024 Received: January 18, 2024

Dear Deze Wang:

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 (the 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 available 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}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director

{2}------------------------------------------------

DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K231365

Device Name

Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate, aka Synguard C+ Nitrile Exam Gloves

Indications for Use (Describe)

Tested chemotherapy drugs are as follows:

Test Chemotherapy drug & Concentration	Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU)(3.3 mg/ml)	12.1 min.
Cyclophosphamide (Cytoxan) (20.0 mg/ml)	>240 min.
Doxorubicin Hydrichloride (2.0mg/)	>240 min.
Etoposide (Toposar) (20.0mg/ml)	>240 min.
Fluorouracil (50.0mg/ml)	>240 min.
Methotrexate (25.0 mg/ml)	>240 min.
Paclitaxel (Taxol) (6.0 mg/ml)	>240 min.
Thiotepa(10.0 mg/ml)	10.1 min.
Vincristine Sulfate(1.0 mg/ml)	>240 min.
Cisplatin(1.0 mg/ml)	>240 min.
Dacarbazine(10 mg/ml)	>240 min.
Mitomycin C(0.5 mg/ml)	>240 min.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.

Warning: Do not use with Carmustine or Thiotepa

Fentanyl Citrate & Concentration	Minimum Breakthrough Detection Times
Fentanyl Citrate Injection(100 mcg/2ml)	>240 min.

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.

{4}------------------------------------------------

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.gov

"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."

{5}------------------------------------------------

Anhui Intco Medical Products Co., Ltd.

No.6 Haitang South Road, Suixi, Anhui, China

510(K) SUMMARY K231365

(As requirement by 21 CFR 807.92)

1. Submitter's Identification:

Anhui Intco Medical Products Co, Itd. No.6 Haitang South Road, Suixi Wuhu Modern Industrial Park Suixi County, Huaibei City, Anhui Province,China

Contact Person :

Max Li Tel: 86-18918364816

Date summary prepared: March 1, 2024

2. Product Trade Name:

Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate.

Aka Synguard C+ Nitrile Exam Gloves

Device Classification Name: 3.

Patient Examination gloves (21 CFR 880.6250)

4. Device Class:

Class I.

న్. Product Code:

LZA, LZC,OPJ,QDO.

Predicate Devices: 6.

K200671 - Ansell Healthcare Products LLC Powder-Free Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl

7. Reason for 510(k) Submission:

New device.

8. Device Description:

The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single

{6}------------------------------------------------

use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:

· Ambidextrous with beaded cuff and straight fingers
Finger-textured,
Blue colored

· Containing Hyaluronic Acid coating.
· Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
· Tested against chemotherapy drugs and fentanyl citrate.

The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

9. Indications for Use:

Tested chemotherapy drugs are as follows:

Test Chemotherapy drug & Concentration

Average Breakthrough Detection Time (Minutes)

Carmustine (BCNU)(3.3 mg/ml)	12.1 min.
Cyclophosphamide (Cytoxan) (20.0 mg/ml)	>240 min.
Doxorubicin Hydrichloride (2.0mg/)	>240 min.
Etoposide (Toposar) (20.0mg/ml)	>240 min.
Fluorouracil (50.0mg/ml)	>240 min.
Methotrexate (25.0 mg/ml)	>240 min.
Paclitaxel (Taxol) (6.0 mg/ml)	>240 min.
Thiotepa(10.0 mg/ml)	10.1 min.
Vincristine Sulfate(1.0 mg/ml)	>240 min.
Cisplatin(1.0 mg/ml)	>240 min.
Dacarbazine(10 mg/ml)	>240 min.
Mitomycin C(0.5 mg/ml)	>240 min.

Warning: Do not use with Carmustine or Thiotepa

Fentanyl Citrate & Concentration Minimum Breakthrough Detection Times Fentanyl Citrate Injection(100 mcg/2ml)

>240 min.

10. Technological Characteristics Comparison Table:

Characteristics	Acceptance Criteria	Anhui Intco MedicalProducts Co., Ltd.Nitrile Patient ExaminationGloves with HyaluronicAcid Blue Colored andTested for Use withChemotherapy Drugs andFentanyl citrate	Ansell Healthcare ProductsLLC Powder-Free Microflex®Nitrile Patient ExaminationGloves with Aloe andChamomile Pink ColoredTested for Use withChemotherapy Drugs andFentanyl	ComparisonConclusions
-----------------	---------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------

{7}------------------------------------------------

K-Number		K231365	K200671
Product Code	LZA,LZC,OPJ,QDO	LZA,LZC,OPJ,QDO	LZA, LZC,QDO
Intended use	/	A powder-free patientexamination glove is adisposable device intendedfor medical purposes thatis worn on the examiner'shand to preventcontamination betweenpatient and examiner. Theglove was tested for usewith Chemotherapy Drugsand Fentanyl Citrate as perASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs.	A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. Theglove was tested for use withChemotherapy Drugs as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves to Permeationby Chemotherapy Drugs.	Same
Material used	Nitrile	Nitrile	Nitrile	Identical
Color	Blue	Blue	Blue	Same
Single use	Single Use	Yes	Yes	Same
Non Sterile	Non Sterile	Non Sterile	Non Sterile	Same
Other	/	Hyaluronic Acidcoated on	Aloe and Chamomilecoated on	Different(1)
		the donning surface	the donning surface
Dimensions	Overall Length (mm)For XS, S,Min 220mmFor M,L,XL,XXLMin 230mmWidth (± 10mm)Size XS = 70mmSize S = 80mmSize M = 95mmSize L = 110mmSize XL = 120mmSize XXL = 130mmThickness at Palm (mm)Min; 0.05mmThickness at Finger Tip(mm) Min 0.05 mm	Complies with ASTMD6319-19X Small 70±10Small 80 ±10Medium 95±10Large 110 ±10X large 120 ±10XX Large 130 ±10ThicknessPalm - 0.05mm min.Finger - 0.05 mm min.	Complies with ASTMD6319-10X Small 75±5Small 85 ±5Medium 95±5Large 105 ±5X large 115 ±5XX Large N/AThicknessPalm - 0.06mm min.Finger - 0.09 mm min	Similar
Physicalproperties	Before AgeingTensile Strength (MPa) =14minUltimate Elongation (%) =500minAfter AgingTensile Strength (MPa) =14minUltimate Elongation (%) =400min	Meets ASTM D6319-19Tensile Strength:Before Aging 14 MPa,min.After Aging 14 MPa,min.Elongation:Before Aging 500% min.After Aging 400%min.	Meets ASTM D6319-10Tensile Strength:Before Aging 16 MPa,min.After Aging 14 MPa,min.Elongation:Before Aging 500% min.After Aging 400% min.	Meets thecriteria
Freedom frompinholes	AQL 2.5Inspection Level G-1	In accordance with ASTMD6319-19 andASTM D5151-19, G-1,AQL 2.5	In accordance with ASTMD6319-10 andASTM D5151-06 , AQL 2.5	Meets thecriteria
ResidualPowder	Less than 2mg per gloveASTM D 6124-06	Average powder residue< 2mg per glove	Average powder residue≤ 2mg per glove	Meets thecriteria
-Primary SkinIrritationTest	ISO10993-10:2010	Under the conditionsof this study, the testarticle was a non-irritant.	Under the conditions of thisstudy, not an irritant.	Same
DermalSensitizationAssay	ISO10993-10:2010	Under the conditionsof this study, the testarticle was a non-sensitizer.	Under the conditions of thisstudy, not a sensitizer.	Same
Acutesystemictoxicity	ISO 10993-11:2017	Under the conditionsof this study,Noevidence of acutesystemictoxicity	Under the conditions of thisstudy,No evidence of acutesystemic toxicity	Same
ResistanceagainstChemotherapyDrugs	Standards Practice forAssessment of resistanceof Medical Glove toPermeation byChemotherapy drugs	1)Carmustine (BCNU)(3.3 mg/ml), Breakthroughtime: 12.1 min.2) Cyclophosphamide	1)Carmustine (BCNU)(3.3 mg/ml), Breakthroughtime: 17.4 min.	Similar

{8}------------------------------------------------

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

ASTM D6978-05(2013)
	1) (Cytoxan), (20.0 mg/ml),Breakthrough time:>240 min.3) DoxorubicinHydrochloride (2.0mg/),Breakthrough time: >240 min.4) Etoposide (Toposar)(20.0mg/ml), Breakthroughtime: >240 min.5) Fluorouracil(50.0mg/ml), Breakthroughtime:>240 min.6) Methotrexate(25.0 mg/ml), Breakthroughtime: >240 min.7) Paclitaxel (Taxol)(6.0 mg/ml), Breakthroughtime: >240 min.8) ThiotepaBreakthrough time:10.1 min.9) Vincristine Sulfate(1.0 mg/ml), Breakthroughtime:>240 min.10) Cisplatin(1.0 mg/ml), Breakthroughtime:>240 min.11) Dacarbazine(10 mg/ml), Breakthroughtime:>240 min.12) Mitomycin C(0.5 mg/ml), Breakthroughtime:>240 min.13) Fentanyl CitrateInjection(100 mcg/2ml),Breakthrough time:>240min.	2) Cyclophosphamide(Cytoxan), (20.0 mg/ml),Breakthrough time:>240 min.3) Doxorubicin Hydrochloride(2.0mg/), Breakthroughtime: >240 min.4) Etoposide (Toposar)(20.0mg/ml), Breakthroughtime: >240 min.5)6) Fluorouracil (50.0mg/ml),Breakthrough time:>240 min.6) Methotrexate(25.0 mg/ml), Breakthroughtime: >240 min.7) Paclitaxel (Taxol)(6.0 mg/ml), Breakthroughtime: >240 min.8) ThiotepaBreakthrough time:67.1 min.9)Vincristine Sulfate(1.0 mg/ml), Breakthroughtime:>240 min.

{10}------------------------------------------------

Analysis (1): The proposed device added the Hyaluronic Acid. while the predicate device added the Aloe and Chamomile, they are not the animal derived. Biocompatibility testing is the safety and performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference does not raise any new safety or performance questions.

11. Non-clinical Testing

The following non-clinical tests were performed:

ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application. ●
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical ● Gloves.
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices Part 23, Tests for ● Irritation.
ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices Part 5, Tests for ● In Vitro Cytotoxicity.
ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices Part 11, Tests for ● Systemic Toxicity.

12. Clinical Testing

N/A.

13. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored 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 K200671. Ansell Healthcare Products LLC Powder-Free Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl.

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.