Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

• K Number: K230662
• Device Name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
• Manufacturer: Zhonghong Pulin Medical Products Co.,Ltd.
• Date Cleared: 2023-10-26 ( 230 days)
• Product Code: LZA LZC OPJ QDO
• Regulation Number: 880.6250

Intended Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.

Predicate Devices

K193555

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable medical glove, and the description focuses on material properties, testing standards, and intended use for contamination prevention. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
The device's intended use is to prevent contamination, not to treat or cure a disease or medical condition.

Diagnostic

No

Explanation: The device is a medical examination glove designed to prevent contamination between patient and examiner, and is not intended to diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical, disposable glove made of nitrile, which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or procedures.
• Device Description: The description reinforces this by detailing the physical characteristics of the gloves and their testing for resistance to certain drugs, which is relevant to their barrier function in a medical setting.
• Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
• No Mention of Diagnostic Testing: There is no mention of the device being used for any form of diagnostic testing or analysis of patient samples.

The testing for chemotherapy drugs and Fentanyl Citrate is related to the performance and safety of the glove as a barrier, not its use in diagnosing a condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.
Warning: Do not use with Carmustine and Thiotepa.

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ, QDO

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Biocompatibility Testing
The biocompatibility evaluation for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs was conducted in accordance with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

• Test for Skin Sensitization Potential

  • Standard: ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10
  • Acceptance Criteria: Under the conditions of the testing, not a sensitizer
  • Results: The primary irritation indexes of the polar and non-polar test group were both calculated to be 0.
  • Summary: Pass

• Test for Irritation Potential

  • Standard: ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10
  • Acceptance Criteria: Under the conditions of the testing, not an irritant.
  • Results: The skin sensitization rates of polar and non-polar extract group were both determined with 0%.
  • Summary: Pass

• Evaluate In Vitro Cytotoxicity Potential

  • Standard: ISO 10993-5:2009
  • Acceptance Criteria: Under the conditions of the testing, non-cytotoxic.
  • Results: The cell viability of the 100% test article extract was 86.2%
  • Summary: Pass

Performance Testing (Bench)
Physical performance qualities of the Subject device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs to support the addition of the labeling claim: Tested for use with chemotherapy drugs, fentanyl citrate, and select other drugs.

• Measure residual powder on medical gloves

  • Standard: ASTM D6124-06 (Reapproved 2017)
  • Acceptance Criteria: powder residue limit of 2.0 mg/glove
  • Results: 1.9 mg/glove
  • Summary: Pass

• Detection of holes in medical gloves

  • Standard: ASTM D5151-19
  • Acceptance Criteria: Freedom free holes AQL: 2.5 (ISO 2859-1)
  • Results: 0 gloves of failure
  • Summary: Pass

• Evaluate physical dimensions

  • Standard: ASTM D6319-19, (7.4 & ASTM D3767-03(2020))
  • Acceptance Criteria:
    • XS: width 70±10mm Length ≥270 mm
    • S: width 80±10mm Length ≥270 mm
    • M: width 95±10mm Length ≥270 mm
    • L: width 110±10mm Length ≥270 mm
    • XL: width 120±10mm Length ≥270 mm
    • XXL: width 130±10mm Length ≥270 mm
    • Finger Thickness ≥0.05 mm
    • Palm Thickness ≥0.05 mm
  • Results:
    • Length: 287-293 mm (XS), 288-297 mm (S), 287-300mm (M), 290-297 mm (L), 283-301 mm (XL), 292-300 mm (XXL)
    • Width: 78-80mm (XS), 84-86mm (S), 96-97mm (M), 105-107mm (L), 113-115mm (XL), 122-124mm (XXL)
    • Finger Thickness: 0.082-0.185mm
    • Palm Thickness: 0.065-0.123mm
  • Summary: Pass for all sizes and thickness measures.

• Evaluate physical properties: Before aging

  • Standard: ASTM D6319-19, 7.5 & ASTM D412-16 (2021)
  • Tensile strength
    • Acceptance Criteria: ≥14MPa
    • Results: (19.9-28.9)MPa
    • Summary: Pass
  • Ultimate Elongation
    • Acceptance Criteria: ≥500%
    • Results: (540-580)%
    • Summary: Pass

• After Accelerated Aging

  • Standard: ASTM D6319-19, 7.5& ASTM D412-16 (2021) & ASTM D573-04 (2019)
  • Tensile strength
    • Acceptance Criteria: ≥14MPa
    • Results: (20.2-29.1)MPa
    • Summary: Pass
  • Ultimate Elongation
    • Acceptance Criteria: ≥400%
    • Results: (508-528)%
    • Summary: Pass

• Evaluate permeation characteristics

  • Standard: ASTM D6978

  • Key Results:

    • Bendamustine HCl 5 mg/ml (5,000 ppm): > 240 min.
    • Bleomycin Sulfate 15 mg/ml (15,000 ppm): > 240 min.
    • Busulfan 6 mg/ml (6,000 ppm): > 240 min.
    • Carboplatin 10.0 mg/ml (10,000 ppm): > 240 min.
    • Carfilzomib 2 mg/ml (2,000 ppm): > 240 min.
    • Carmustine 3.3 mg/ml (3,300 ppm): 21.1 (24.2, 21.1, 25.3) min. (Reported as 21.1 min.)
    • Cetuximab 2 mg/ml (2,000 ppm): > 240 min.
    • Chloroquine 50 mg/ml (50,000 ppm): > 240 min.
    • Cisplatin 1 mg/ml (1,000 ppm): > 240 min.
    • Cladribine 1 mg/ml (1000 ppm): > 240 min.
    • Cyclophosphamide 20 mg/ml (20.000 ppm): > 240 min.
    • Cyclosporin A 100 mg/ml (100,000 ppm): > 240 min.
    • Cytarabine(Cytosine) 100.0 mg/ml (100,000 ppm): > 240 min.
    • Cytovene(Ganciclovir) 10 mg/ml(10,000 ppm): > 240 min.
    • Dacarbazine 10 mg/ml(10,000 ppm): > 240 min.
    • Daunorubicin HCl 5 mg/ml (5,000 ppm): > 240 min.
    • Decitabine 5 mg/ml(5,000 ppm): > 240 min.
    • Docetaxel 10 mg/ml (10.000 ppm): > 240 min.
    • Doxorubicin HCl 2 mg/ml (2,000 ppm): > 240 min.
    • Epirubicin HCl (Ellence) 2 mg/ml (2,000 ppm): > 240 min.
    • Etoposide 20 mg/ml (20,000 ppm): > 240 min.
    • Fludarabine 25.0 mg/ml (25,000 ppm): > 240 min.
    • All others listed under the "Chemotherapy Drugs and Fentanyl Citrate Injection Tested with Minimum Breakthrough Detection Time as Tested per ASTM D6978" table in the "Summary of Non-Clinical Testing" section showed "> 240 min."
    • Thiotepa 10 mg/ml (10,000 ppm): 74.9 (74.9, 96.7, 79.0) min. (Reported as 74.9 min.)
    • Fentanyl Citrate Injection 100mcg/2mL: > 240 min.

  • Summary: All results passed the acceptance criteria, except for Carmustine and Thiotepa, which had breakthrough times below 240 minutes but were noted with a warning not to use the gloves with these drugs.

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

Not Found

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

K193555

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

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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, 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.

October 26, 2023

Zhonghong Pulin Medical Products Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K230662

Trade/Device Name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: September 26, 2023 Received: September 26, 2023

Dear Boyle 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/cdrb/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 ([e-mail]) or phone [phone] 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 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) K230662

Device Name

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

Indications for Use (Describe)

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.

Chemotherapy Drug	Concentration	Breakthrough Detection Time (minutes)
Bendamustine HCl	5 mg/ml (5,000 ppm)	> 240
Bleomycin Sulfate	15 mg/ml (15,000 ppm)	> 240
Busulfan	6 mg/ml(6,000 ppm)	> 240
Carboplatin	10.0 mg/ml (10,000 ppm)	> 240
Carfilzomib	2 mg/ml (2,000 ppm)	> 240
Carmustine	3.3 mg/ml (3,300 ppm)	21.1 (24.2, 21.1, 25.3)
Cetuximab	2 mg/ml (2,000 ppm)	> 240
Cisplatin	1 mg/ml (1000 ppm)	> 240
Cladribine	1 mg/ml (1000 ppm)	> 240
Cyclophosphamide	20 mg/ml (20.000 ppm)	> 240
Cytarabine(Cytosine)	10 mg/ml(10,000 ppm)	> 240
Cytovene(Ganciclovir)	10 mg/ml(10,000 ppm)	> 240
Dacarbazine	10 mg/ml(10,000 ppm)	> 240
Daunorubicin HCl	5 mg/ml (5,000 ppm)	> 240
Decitabine	5 mg/ml(5,000 ppm)	> 240
Docetaxel	10 mg/ml (10.000 ppm)	> 240
Doxorubicin HCl	2 mg/ml (2,000 ppm)	> 240
Epirubicin HCI (Ellence)	20 mg/ml (20,000 ppm)	> 240
Etoposide	20 mg/ml (20,000 ppm)	> 240
Fludarabine	25.0 mg/ml (25,000 ppm)	> 240
Fluorouracil	50 mg/ml,(50,000 ppm)	> 240
Fulvestrant	50 mg/ml(50,000 ppm)	> 240
Gemcitabine	38 mg/ml (38,000 ppm)	> 240
Idarubicin HCL	1.0 mg/ml (1,000 ppm)	> 240
lfosfamide	50 mg/ml (50,000 ppm)	> 240
Irinotecan HCI	20 mg/ml (20,000 ppm)	> 240
Mechlorethamine HCl	1 mg/mI(1,000 ppm)	> 240
Melphalan	5 mg/ml(5000 ppm)	> 240
Methotrexate	25 mg/ml (25,000 ppm)	> 240
Mitomycin C	0.5 mg/ml (500 ppm)	> 240
Mitoxantrone HCL	2 mg/ml (2,000 ppm)	> 240
Oxaliplatin	5 mg/ml (5,000 ppm)	> 240
Paclitaxel	6 mg/ml (6,000 ppm)	> 240
Paraplatin	10 mg/ml (10,000 ppm)	> 240
Pemetrexed	25 mg/ml (25,000 ppm)	> 240
Raltitrexed	0.5 mg/ml (500 ppm)	> 240
Rituximab	10 mg/ml (10,000 ppm)	> 240
Temsirolimus	25 mg/ml (25,000 ppm)	> 240
Thiotepa	10 mg/ml(10,000 ppm)	74.9 (74.9, 96.7, 79.0)
Topotecan	1 mg/ml (1,000 ppm)	> 240
Trisenox (Arsenic Trioxide)	1 mg/ml (1,000 ppm)	> 240
Vinblastine,	1 mg/ml (1,000 ppm)	> 240
Vincristine sulfate (Oncovin)	1 g/ml (1,000 ppm)	> 240
Vinorelbine	10 mg/ml(10,000 ppm)	> 240
Fentanyl Citrate and other Drugs	Concentration	Breakthrough Detection Time (minutes)
Chloroquine	50 mg/ml (50,000 ppm)	> 240
Cyclosporin A	100.0 mg/ml (100,000 ppm)	> 240
MESNA	100 mg/ml(100,000 ppm)	> 240
Retrovir	10 mg/ml(10,000 ppm)	> 240
Triclosan	3 mg/ml(3,000 ppm)	> 240
Zoledronic Acid	1 mg/25ml (40 ppm)	> 240
Fentanyl Citrate Injection	100mcg/2mL	> 240

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Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml). Warning: Do not use with Carmustine and Thiotepa.

Type of Use (Select one or both, as applicable)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K230662

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Name: Zhonghong Pulin Medical Products Co.,Ltd. Address: West Industrial Park, BDA, Luannan County, Tangshan City, 063500 Hebei, P.R. China. Phone Number: [phone] Contact: Li Yunjiao Date of Preparation: 2023.10.23

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

2.0 Device Information

Trade name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove

3.0 Classification

Production code: LZA, LZC, OPJ, QDO Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Name: Ever Global (Vietnam) Enterprise Corp. Device Trade Name:

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Image /page/6/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the company name "ZHONGHONG" is written in a larger, bolder font, with "PULIN" written below it in a smaller font.

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K193555

5.0 Indication for Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug	Concentration	Breakthrough Detection Time (minutes)
Bendamustine HCI	5 mg/ml (5,000 ppm)	> 240
Bleomycin Sulfate	15 mg/ml (15,000 ppm)	> 240
Busulfan	6 mg/ml(6,000 ppm)	> 240
Carboplatin	10.0 mg/ml (10,000 ppm)	> 240
Carfilzomib	2 mg/ml (2,000 ppm)	> 240
Carmustine	3.3 mg/ml (3,300 ppm)	21.1 (24.2, 21.1, 25.3)
Cetuximab	2 mg/ml (2,000 ppm)	> 240
Cisplatin	1 mg/ml (1000 ppm)	> 240
Cladribine	1 mg/ml (1000 ppm)	> 240
Cyclophosphamide	20 mg/ml (20.000 ppm)	> 240
Cytarabine(Cytosine)	10 mg/ml(10,000 ppm)	> 240
Cytovene(Ganciclovir)	100.0 mg/ml (100,000 ppm)	> 240
Dacarbazine	10 mg/ml(10,000 ppm)	> 240
Daunorubicin HCI	5 mg/ml (5,000 ppm)	> 240
Decitabine	5 mg/ml(5,000 ppm)	> 240
Docetaxel	10 mg/ml (10.000 ppm)	> 240
Doxorubicin HCI	2 mg/ml (2,000 ppm)	> 240
Epirubicin HCI (Ellence)	20 mg/ml (20,000 ppm)	> 240
Etoposide	20 mg/ml (20,000 ppm)	> 240
Fludarabine	25.0 mg/ml (25,000 ppm)	> 240
Fluorouracil	50 mg/ml (50,000 ppm)	> 240
Fulvestrant	50 mg/ml(50,000 ppm)	> 240
Gemcitabine	38 mg/ml (38,000 ppm)	> 240
Idarubicin HCI	1.0 mg/ml (1,000 ppm)	> 240
Ifosfamide	50 mg/ml (50,000 ppm)	> 240
Irinotecan HCI	20 mg/ml (20,000 ppm)	> 240
Mechlorethamine HCI	1 mg/ml(1,000 ppm)	> 240
Melphalan	5 mg/ml(5000 ppm)	> 240
Methotrexate	25 mg/ml (25,000 ppm)	> 240
Mitomycin C	0.5 mg/ml (500 ppm)	> 240
Mitoxantrone HCI	2 mg/ml (2,000 ppm)	> 240
Oxaliplatin	5 mg/ml (5,000 ppm)	> 240
Paclitaxel	6 mg/ml (6,000 ppm)	> 240
Paraplatin	10 mg/ml (10,000 ppm)	> 240
Pemetrexed	25 mg/ml (25,000 ppm)	> 240
Raltitrexed	0.5 mg/ml (500 ppm)	> 240
Rituximab	10 mg/ml (10,000 ppm)	> 240
Temsirolimus	25 mg/ml (25,000 ppm)	> 240
Thiotepa	10 mg/ml(10,000 ppm)	74.9 (74.9, 96.7, 79.0)
Topotecan	1 mg/ml (1,000 ppm)	> 240

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Image /page/7/Picture/1 description: The image shows the logo for ZHONGHONG PULIN. The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the words "ZHONGHONG" are stacked on top of the word "PULIN".

	Concentration		Breakthrough Detection Time (minutes)
Trisenox (Arsenic Trioxide)	1 mg/ml (1,000 ppm)		> 240
Vinblastine,	1 mg/ml (1,000 ppm)		> 240
Vincristine sulfate (Oncovin)	1 g/ml (1,000 ppm)		> 240
Vinorelbine	10 mg/ml(10,000 ppm)		> 240
Fentanyl Citrate and other Drugs
Chloroquine	50 mg/ml (50,000 ppm)		> 240
Cyclosporin A	100.0 mg/ml (100,000 ppm)		> 240
MESNA	100 mg/ml(100,000 ppm)		> 240
Retrovir	10 mg/ml(10,000 ppm)		> 240
Triclosan	3 mg/ml(3,000 ppm)		> 240
Zoledronic Acid	1 mg/25ml (40 ppm)		> 240
Fentanyl Citrate Injection	100mcg/2mL		> 240

Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml).

Warning: Do not use with Carmustine and Thiotepa.

6.0 Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.

7.0 Comparison of Technical Characteristics

Item	Subject device	Predicate device	Comparison
510(k)
number	Nitrile Exam Glove, Extended cuff,
Tested For Use With
Chemotherapy Drugs, Fentanyl
Citrate, And Select Other Drugs	Disposable Powder Free Nitrile
Examination Glove, Blue Color,
Tested For Use With Chemotherapy
Drugs And Fentanyl Citrate	/
Product
Code	LZA, LZC, OPJ, QDO	LZA, LZC, QDO	Similar
Regulation
No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications
For Use	A patient examination gloves is a
disposable device intended for medical
purpose that is worn on the examiner's
hand or fingers to prevent	A patient examination gloves is a
disposable device intended for
medical purpose that is worn on the
examiner's hand or fingers to	Similar
contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Concentration Breakthrough Detection Time (minutes)	prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.
Test Chemotherapy Drug Concentration (mg/ml) Minimum Breakthrough Detection Time (Min.)
Bendamustine HCl 5 mg/ml (5,000 ppm) > 240	1 Arsenic Trioxide (1.0 mg/ml) > 240
Bleomycin Sulfate 15 mg/ml (15,000 ppm) > 240	2 Azacitidine (Vidaza) (25.0 mg/ml) > 240
Busulfan 6 mg/ml (6,000 ppm) > 240	3 Bendamustine HCl (5.0 mg/ml) > 240
Carboplatin 10.0 mg/ml (10,000 ppm) > 240	4 Bleomycin Sulfate (15.0 mg/ml) > 240
Carfilzomib 2 mg/ml (2,000 ppm) > 240	5 Bortezomib (Velcade) (1.0 mg/ml) > 240
Carmustine 3.3 mg/ml (3,300 ppm) 21.1 (24.2, 21.1, 25.3)	6 Busulfan (6.0 mg/ml) > 240
Cetuximab 2 mg/ml (2,000 ppm) > 240	7 Carboplatin (10.0 mg/ml) > 240
Cisplatin 1 mg/ml (1000 ppm) > 240	8 Carfilzomib (2.0 mg/ml) > 240
Cladribine 1 mg/ml (1000 ppm) > 240	9 Carmustine (BCNU), (3.3 mg/ml) 6.2
Cyclophosphamide 20 mg/ml (20.000 ppm) > 240	10 Cetuximab (Erbitux) (2.0 mg/ml) > 240
Cytarabine(Cytosine) 10 mg/ml(10,000 ppm) > 240	11 Chloroquine (50.0 mg/ml) > 240
Cytovene (Ganciclovir) 10 mg/ml(10,000 ppm) > 240	12 Cisplatin (1.0 mg/ml) > 240
Dacarbazine 10 mg/ml (10,000 ppm) > 240	13 Cladribine (1.0 mg/ml) > 240
Daunorubicin HCl 5 mg/ml (5,000 ppm) > 240	14 Cyclophosphamide (20.0 mg/ml) > 240
Decitabine 5 mg/ml (5,000 ppm) > 240	15 Cyclosporine A (100.0 mg/ml) > 240
Docetaxel 10 mg/ml (10.000 ppm) > 240	16 Cytarabine (100.0 mg/ml) > 240
Doxorubicin HCl 2 mg/ml (2,000 ppm) > 240	17 Cytovene (Ganciclovir) (10.0 mg/ml) > 240
Epirubicin HCl (Ellence) 20 mg/ml (20,000 ppm) > 240	18 Dacarbazine (10.0 mg/ml) > 240
Etoposide 20 mg/ml (20,000 ppm) > 240	19 Daunorubicin (5.0 mg/ml) > 240
Fludarabine 25.0 mg/ml (25,000 ppm) > 240	20 Decitabine (5.0 mg/ml) > 240
Fluorouracil 50 mg/ml, (50,000 ppm) > 240	21 Docetaxel (10.0 mg/ml) > 240
Fulvestrant 50 mg/ml(50,000 ppm) > 240	22 Doxorubicin Hydrochloride (2.0 mg/ml) > 240
	23 Epirubicin (Ellence) (2.0 mg/ml) > 240
	24 Etoposide (20.0 mg/ml) > 240
	25 Fludarabine (25.0 mg/ml) > 240
	Gemcitabine 38 mg/ml (38,000 ppm)

240 | 26 Fluorouracil (50.0 mg/ml) > 240 | 27 Fulvestrant (50.0 mg/ml) > 240 |
| Idarubicin HCL 1.0 mg/ml (1,000 ppm)
240 | 28 Gemcitabine (38.0 mg/ml) > 240 | | |
| Ifosfamide 50 mg/ml (50,000 ppm) | 29 Idarubicin (1.0 mg/ml) > 240 | | |

General Comparison Table

8

Image /page/8/Picture/1 description: The image contains a logo with the letters "Z|Z" in white on a red square. To the right of the square, the words "ZHONGHONG" and "PULIN" are written in black, with "ZHONGHONG" on top of "PULIN". The logo appears to represent a company or organization named Zhonghong Pulin.

9

Image /page/9/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" inside, separated by a vertical line. To the right of the square are the words "ZHONGHONG" on the top line and "PULIN" on the bottom line, both in a sans-serif font.

Irinotecan HCl 20 mg/ml (20,000 ppm) > 240	30 Ifosfamide (50.0 mg/ml) > 240
Mechlorethamine HCl 1 mg/ml(1,000 ppm) > 240	31 Irinotecan (20.0 mg/ml) > 240
Melphalan 5 mg/ml (5000 ppm) > 240	32 Mechlorethamine HCl (1.0 mg/ml) > 240
Methotrexate 25 mg/ml (25,000 ppm) > 240	33 Melphalan (5.0 mg/ml) > 240
Mitomycin C 0.5 mg/ml (500 ppm) > 240	34 Methotrexate (25 mg/ml) > 240
Mitoxantrone HCL 2 mg/ml (2,000 ppm) > 240	35 Mesna (100 mg/ml) > 240
Oxaliplatin 5 mg/ml (5,000 ppm) > 240	36 Mitomycin C (0.5 mg/ml) > 240
Paclitaxel 6 mg/ml (6,000 ppm) > 240	37 Mitoxantrone (2.0 mg/ml) > 240
Paraplatin 10 mg/ml (10,000 ppm) > 240	38 Oxaliplatin (5.0 mg/ml) > 240
Pemetrexed 25 mg/ml (25,000 ppm) > 240	39 Paclitaxel (6.0mg/ml) > 240
Raltitrexed 0.5 mg/ml (500 ppm) > 240	40 Paraplatin (10.0 mg/ml) > 240
Rituximab 10 mg/ml (10,000 ppm) > 240	41 Pemetrexed (25.0 mg/ml) > 240
Temsirolimus 25 mg/ml (25,000 ppm) > 240	42 Pertuzumab (30.0 mg/ml) > 240
Thiotepa 10 mg/ml(10,000 ppm) 74.9 (74.9, 96.7, 79.0)	43 Raltitrexed (0.5 mg/ml) > 240
Topotecan 1 mg/ml (1,000 ppm) > 240	44 Retrovir (10.0 mg/ml) > 240
Trisenox (Arsenic Trioxide) 1 mg/ml (1,000 ppm) > 240	45 Rituximab (10.0 mg/ml) > 240
Vinblastine, 1 mg/ml (1,000 ppm) > 240	46 Temsirolimus (25.0 mg/ml) > 240
Vincristine sulfate (Oncovin) 1 g/ml (1,000 ppm) > 240	47 Thiotepa (10.0 mg/ml) 13.6
Vinorelbine 10 mg/ml (10,000 ppm) > 240	48 Topotecan HCI (1.0 mg/ml) > 240
Fentanyl Citrate and other Drugs
Concentration Breakthrough
Detection Time (minutes)	49 Trastuzumab (21.0 mg/ml) > 240
Chloroquine 50 mg/m (50,000 ppm) > 240	50 Triclosan (2.0 mg/ml) > 240
Cyclosporin A 100.0 mg/ml (100,000 ppm) > 240	51 Trisenox (1.0 mg/ml) > 240
MESNA 100 mg/ml(100,000 ppm) > 240	52 Vinblastine (1.0 mg/ml) > 240
Retrovir 10 mg/ml(10,000 ppm) > 240	53 Vincristine Sulfate (1.0 mg/ml) > 240
Triclosan 3 mg/ml(3,000 ppm) > 240	54 Vinorelbine (10.0 mg/ml) > 240
Zoledronic Acid 1 mg/25ml (40 ppm) > 240	55 Zoledronic Acid (0.8 mg/ml) > 240
Fentanyl Citrate Injection 100mcg/2mL > 240	Warning: do not use with
Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
Note: The maximum testing time is 240	Carmustine (BCNU), 3.3 mg/ml 6.2 minutes
Thiotepa, 10.0 mg/ml 13.6 minutes
	Fentanyl Permeation Resistance
Claim - Under the testing conditions
of ASTM D6978-05, Fentanyl Citrate
Injection (100mcg/2mL) was found
to have no breakthrough detected
up to 240 minutes.

10

Image /page/10/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of two parts: a red square with the letters "Z" and "Z" separated by a vertical line, and the company name written in black text to the right of the square. The company name is written in two lines, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.

| | breakthrough time of 21.1 minutes with
Carmustine (3.3 mg/ml), 74.9 minutes
with Thio Tepa (10 mg/ml).
Warning: Do not use with Carmustine
and Thiotepa. | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|
| Powdered or
Power free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Main Material | Powder-Free Nitrile | Nitrile | Similar |
| Colors | Blue | Blue | Same |

Device Dimensions Comparison Table

| Subject
device

K230662	Designation	Size (mm)
		XS	S	M	L	XL	XXL
	Length, mm	287-293	288-297	287-300	290-297	283-301	292-300
	Criteria	≥270	≥270	≥270	≥270	≥270	≥270
Comply
with ASTM
D6319	Results	Pass	Pass	Pass	Pass	Pass	Pass
	Width, mm	78-80	84-86	96-97	105-107	113-115	122-124
	Criteria	70±10	80±10	95±10	110±10	120±10	130±10
	Results	Pass	Pass	Pass	Pass	Pass	Pass
	Thickness, mm:
	Finger	(0.082-0.185)
	Criteria	> 0.05
	Results	pass
	Palm	(0.065-0.123)
	Criteria	> 0.05
	Results	pass
	Designation	Size (mm)
Predicate
Device
(K193555)		XS	S	M	L	XL
	Length, mm	≥300	≥300	≥300	≥300	≥300
	Criteria	≥220	≥220	≥230	≥230	≥230
	Results	Pass	Pass	Pass	Pass	Pass
	Width, mm	70±10	80±10	95±10	110±10	120±10
	Criteria	70±10	80±10	95±10	110±10	120±10
	Results	Pass	Pass	Pass	Pass	Pass
Comply
with ASTM
D6319	Thickness, mm:
	Finger	0.05mm min.
	Criteria	> 0.05
	Results	pass
	Palm	0.05mm min.
	Criteria	> 0.05
	Results	pass
Remarks	Similar. The subject gloves have a minimum length of 270mm.

Performance Comparison Table

| Item | Subject device
K230662 | Predicate device
(K193555) | Remark |

------	---------------------------	-------------------------------	--------

11

Image /page/11/Picture/1 description: The image contains a logo for "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the words "ZHONGHONG" are stacked above the word "PULIN".

| Physical
Properties | | | Comply with ASTM
D6319 | Comply with ASTM
D6319 | Same | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------|---------|------------|-----------------------------------------------|------|
| | Before
Aging | Tensile
Strength | (19.9-28.9)MPa | 14MPa, min | Same | | | |
| | | Criteria | 14MPa, min | 14MPa, min | | | | |
| | | Results | Pass | Pass | | | | |
| | | Ultimate
Elongation | (540-580)% | 500% min | Same | | | |
| | | Criteria | 500% min | 500% min | | | | |
| | | Results | Pass | Pass | | | | |
| | After
Aging | Tensile Strength | (20.2-29.1)MPa | 14MPa, min | Same | | | |
| | | Criteria | 14MPa, min | 14MPa, min | | | | |
| | | Results | Pass | Pass | | | | |
| | | Ultimate Elongation | (508-528)% | 400%min | Same | | | |
| | | Criteria | 400%min | 400%min | | | | |
| | | Results | Pass | Pass | | | | |
| Freedom from Holes | | | accordance with
ASTMD5151 | accordance with
ASTMD5151 | Same | | | |
| | | Criteria | AQL: 2.5 (ISO 2859) | G-1, AQL 2.5 | | | | |
| | | Results | 0 gloves of failure
Pass | Pass | | | | |
| Powder Content | | | Meet the requirements of
ASTM D6319 | Meet the requirements of
ASTM D6319 | Same | | | |
| | | Criteria | 240 min. | | Bendamustine HCl
(5.0 mg/ml)

240 min. | Same | | | |
| | | Bleomycin Sulfate
15 mg/ml (15,000 ppm)
240 min. | | Bleomycin Sulfate
15 mg/ml
240 min. | Same | | | |
| | | Busulfan
6 mg/ml(6,000 ppm)
240 min. | | Busulfan
6 mg/ml
240 min | Same | | | |
| | | Carboplatin
10.0 mg/ml (10,000 ppm)
240 min. | | Carboplatin
10 mg/ml
240 min. | Same | | | |
| | | Carfilzomib
2 mg/ml (2,000 ppm)
240 min. | | Carfilzomib
(2.0 mg/ml)
240 min. | Same | | | |
| | | Carmustine
3.3 mg/ml (3,300 ppm)
21.1 (24.2, 21.1, 25.3)min. | | Carmustine (BCNU)
3.3 mg/ml
37.5 min. | Similar | | | |
| | | Cetuximab
2 mg/ml (2,000 ppm)
240 min. | | Cetuximab (Erbitux)
(2.0 mg/ml)
240 min. | Same | | | |
| | | Chloroquine
50 mg/ml (50,000 ppm)
240 min. | | Chloroquine
(50.0 mg/ml)
240 min. | Same | | | |
| | | Cisplatin
1 mg/ml(1,000 ppm)
240 min. | | Cisplatin
1.0 mg/ml
240 min. | Same | | | |
| | | Cladribine
1 mg/ml (1000 ppm)
240 min. | | Cladribine
(1.0 mg/ml)
240 min. | Same | | | |
| | > 240 min. | | | Cyclophosphamide
20 mg/ml (20.000 ppm)
240 min. | | > 240 min. | Cyclophosphamide
(20.0 mg/ml)
240 min | Same |
| Cyclosporin A | Cyclosporin A | Same | | | | | | |

12

Image /page/12/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line. To the right of the square, the company name is written in black, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.

| 100 mg/ml (100,000 ppm)

240 min. | (100.0 mg/ml)
240 min. | | | | |
|-----------------------------------------------------------------|------------------------------------------------------|--------------|------------------------|------|--|
| Cytarabine(Cytosine)
100.0 mg/ml (100,000 ppm)
240 min. | Cytarabine
(100.0 mg/ml)
240 min | Same | | | |
| Cytovene(Ganciclovir)
10 mg/ml(10,000 ppm)
240 min. | Cytovene (Ganciclovir)
(10.0 mg/ml)
240 min. | Same | | | |
| Dacarbazine
10 mg/ml(10,000 ppm)
240 min. | Dacarbazine (DTIC)
10.0 mg/ml
240 min. | Same | | | |
| Daunorubicin HCl
5 mg/ml (5,000 ppm)
240 min. | Daunorubicin
5 mg/mL
240 min. | Same | | | |
| Decitabine
5 mg/ml(5,000 ppm)
240 min. | Decitabine
(5.0 mg/ml)
240 min. | Same | | | |
| Docetaxel
10 mg/ml (10.000 ppm)
240 min. | Docetaxel
10.0 mg/ml
240 min | Same | | | |
| Doxorubicin HCl
2 mg/ml (2,000 ppm)
240 min. | Doxorubicin HCl
2.0 mg/ml:
240 min | Same | | | |
| Epirubicin HCl (Ellence)
2 mg/ml (2,000 ppm)
240 min. | Epirubicin (Ellence)
2.0 mg/ml
240 min. | Same | | | |
| Etoposide
20 mg/ml (20,000 ppm)
240 min. | Etoposide,
(20.0 mg/ml)
240 min. | Same | | | |
| Fludarabine
25.0 mg/ml (25,000 ppm)
240 min. | Fludarabine
25.0 mg/ml
240 min. | Same | | | |
| Fluorouracil
50 mg/ml,(50,000 ppm)
240 min. | Fluorouracil
50.0 mg/ml:
240 min | Same | | | |
| Fulvestrant
50 mg/ml(50,000 ppm)
240 min. | Fulvestrant
(50.0 mg/ml)
240 min | Same | | | |
| Gemcitabine
38 mg/ml (38,000 ppm)
240 min. | Gemcitabine
38 mg/ml
240 min. | Same | | | |
| Idarubicin HCl
1.0 mg/ml (1,000 ppm)
240 min. | Idarubicin
1 mg/ml
240 min. | Same | | | |
| Ifosfamide
50 mg/ml (50,000 ppm)
240 min. | Ifosfamide
50.0 mg/ml
240 min. | Same | | | |
| Irinotecan HCl
20 mg/ml (20,000 ppm)
240 min. | Irinotecan
20.0 mg/ml
240 min. | Same | | | |
| Mechlorethamine HCl
1 mg/ml(1,000 ppm)
240 min. | Mechlorethamine HCI
1.0 g/ml
240 min. | Same | | | |
| Melphalan
5 mg/ml(5000 ppm)
240 min. | Melphalan
5 mg/ml
240 min. | Same | | | |
| Methotrexate | 25 mg/ml (25,000 ppm)
240 min. | Methotrexate | 25 mg/ml
240 min. | Same | |
| MESNA
100 mg/ml(100,000 ppm) | Mesna
(100 mg/ml) | Same | | | |

13

Image /page/13/Picture/1 description: The image shows the logo for ZHONGHONG PULIN. The logo consists of a red square with the letters "Z|Z" in white, followed by the text "ZHONGHONG" in black, and then "PULIN" in black below it. The logo is simple and modern, with a clear and easy-to-read font.

> 240 min.	> 240 min.
Mitomycin C	Mitromycin C.	Same
0.5 mg/ml (500 ppm)	0.5 mg/ml
> 240 min.	> 240
Mitoxantrone HCL	Mitoxantrone	Same
2 mg/ml (2,000 ppm)	2.0 mg/ml
> 240 min.	> 240 min.
Oxaliplatin	Oxaliplatin	Same
5 mg/ml (5,000 ppm)	5 mg/ml
> 240 min.	> 240 min.
Paclitaxel	Paclitaxel (Taxol)	Same
6 mg/ml (6,000 ppm)	6.0 mg/ml
> 240 min.	> 240 min.
Paraplatin	Paraplatin	Same
10 mg/ml (10,000 ppm)	10 mg/ml
> 240 min.	> 240 min.
Pemetrexed	Pemetrexed	Same
25 mg/ml (25,000 ppm)	(25.0 mg/ml)
> 240 min.	> 240 min.
Raltitrexed	Raltitrexed	Same
0.5 mg/ml (500 ppm)	(0.5 mg/ml)
> 240 min.	> 240 min.
Retrovir	Retrovir	Same
10 mg/ml(10,000 ppm)	10 mg/ml
> 240 min.	> 240 min.
Rituximab	Rituximab	Same
10 mg/ml (10,000 ppm)	10.0 mg/ml
> 240 min.	> 240 min.
Temsirolimus	Temsirolimus	Same
25 mg/ml (25,000 ppm)	(25.0 mg/ml)
> 240 min.	> 240 min.
Thiotepa	Thiotepa	Similar
10 mg/ml(10,000 ppm)	10.0 mg/ml
74.9 (74.9, 96.7, 79.0)min.	13.6min.
Topotecan	Topotecan HCl	Same
1 mg/ml (1,000 ppm)	(1.0 mg/ml)
> 240 min.	> 240 min.
Triclosan	Triclosan	Similar
3 mg/ml(3,000 ppm)	(2.0 mg/ml)
> 240 min.	> 240 min.
Trisenox (Arsenic Trioxide)	Trisenox	Same
1 mg/ml (1,000 ppm)	1.0 mg/ml
> 240 min.	> 240 min.
Vinblastine,	Vinblastine,	Same
1 mg/ml (1,000 ppm)	1 mg/ml (1,000 ppm)
> 240 min.	> 240 min.
Vincristine sulfate (Oncovin)
1 g/ml (1,000 ppm)	Vincristine Sulfate	Same
> 240 min.	1.0 mg/ml
	> 240 min.
Vinorelbine	Vinorelbine	Same
10 mg/ml(10,000 ppm)	10 mg/ml
> 240 min.	> 240 min.
Zoledronic Acid	Zoledronic Acid	Similar
1 mg/25ml (40 ppm)	(0.8 mg/ml)
> 240 min.	> 240 min.
Fentanyl Citrate Injection	Fentanyl Citrate Injection,	Same
100mcg/2mL	(100 mcg/2ml)
> 240 min.	> 240 min

14

Image /page/14/Picture/1 description: The image contains a logo with the text "ZHONGHONG PULIN". To the left of the text is a red square with two white Z's separated by a vertical line. The text is in a simple, sans-serif font and is aligned to the right of the square. The overall design is clean and professional.

Items		Predicate device	Subject device	Remark
		(K193555)	K230662
Material		Nitrile	Nitrile compounds	Similar
Bio-
compatibility	Irritation	Comply with ISO10993-10
Under the conditions of the
study, not an irritant	Comply with ISO10993-10
Under the conditions of the
study, not an irritant	Similar
	Sensitization	Comply with ISO10993-10
Under conditions of the study,
not a sensitizer.	Comply with ISO10993-10
Under conditions of the study,
not a sensitizer.
	Cytotoxicity	Comply with ISO10993-5	Comply with ISO10993-5	Similar
		Extraction conditions:
37°C and 72 hours	Test conditions:
No descriptions in summary
		Under the conditions of the
study, the device is not shown
cytotoxicity	Under conditions of the study,
not cytotoxic

bi

8.0 Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs was conducted in accordance with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

Performance Testing (Bench)

Physical performance qualities of the Subject device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs to support the addition of the labeling claim: Tested for use with chemotherapy drugs, fentanyl citrate, and select other drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

• ASTM D6124-06 (Reapproved 2017), Standard Test Method for -

15

Image /page/15/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" and a vertical line inside, followed by the text "ZHONGHONG" on one line and "PULIN" on the line below. The text is in a simple, sans-serif font and is black.

Residual Powder on Medical Gloves

• ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
• Assessment Of Resistance To Permeation By Chemotherapy Drugs - And Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| No. | Purpose of the
Test | Standard | Acceptance Criteria | Results | Summary |
|-----|--------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------|
| | Methodology | | | | |
| 1 | Test for skin
sensitization
potential | ISO
10993-10:20
10 Biological | Under the conditions of the testing,
not a sensitizer | The primary irritation indexes of the polar and
non-polar test group were both calculated to be 0. | Pass |
| 2 | Test for Irritation
potential | Evaluation Of
Medical Devices

• Part 10 | Under the conditions of the testing,
  not an irritant. | The skin sensitization rates of polar and non-
  polar extract group were both determined with 0%. | Pass |
  | 3 | Evaluate In Vitro
  Cytotoxicity
  potential | ISO
  10993-5:2009 | Under the conditions of the testing,
  non-cytotoxic. | The cell viability of the
  100% test article extract
  was 86.2% | Pass |
  | 4 | Measure residual
  powder on
  medical gloves | ASTM D6124-
  06
  (Reapproved

2017.          | powder residue limit of 2.0
      

mg/glove | 1.9 mg/glove | Pass |
| 5 | Detection of
holes in medical
gloves | ASTM D5151-
19 | Freedom free holes AQL: 2.5 (ISO
2859-1) | 0 gloves of failure | Pass |
| 6 | Evaluate physical
dimensions | ASTM D6319-
19, (7.4 &
ASTM D3767-
03(2 020)) | XS: width 70±10mm Length ≥270
mm | Length: 287-293 mm
Width: 78-80mm | Pass |
| | | | S: width 80±10mm Length ≥270
mm | Length: 288-297 mm
Width: 84-86mm | Pass |
| | | | M: width 95±10mm Length ≥270
mm | Length: 287-300mm
Width: 96-97mm | Pass |
| | | | L: width 110±10mm Length ≥270
mm | Length: 290-297 mm
Width: 105-107mm | Pass |
| | | | XL: width 120±10mm Length ≥270
mm | Length: 283-301 mm
Width: 113-115mm | Pass |
| | | | XXL: width 130±10mm Length
≥270 mm | Length: 292-300 mm
Width: 122-124mm | Pass |
| | Thickness | | Finger ≥0.05 mm Palm ≥0.05 mm | Finger :0.082-0.185mm
Palm: 0.065-0.123mm | Pass |
| | Evaluate physical properties: Before aging | | | | |
| | Tensile strength | ASTM D6319- | ≥14MPa | (19.9-28.9)MPa | Pass |
| | Ultimate | 19, | ≥500% | (540-580)% | Pass |
| | Elongation | 7.5& ASTM
D412-16 (2021) | | | |
| | After Accelerated Aging | | | | |
| | Tensile strength | ASTM D6319- | ≥14MPa | (20.2-29.1)MPa | Pass |
| | Ultimate | 19, 7.5& ASTM | ≥400% | (508-528)% | Pass |
| | Elongation | D412-16 (2021)
&ASTM D573-
04 (2019) | | | |
| 7 | Evaluate
permeation
characteristics | ASTM D6978 | Bendamustine HCI
5 mg/ml (5,000 ppm)

240 min. | | > 240 min. |
| | | | | | |
| me | Bleomycin Sulfate
15 mg/ml (15,000 ppm)
240 min. | > 240 min. | | | |
| | Busulfan
6 mg/ml(6,000 ppm)
240 min. | > 240 min. | | | |
| | Carboplatin
10.0 mg/ml (10,000 ppm)
240 min. | > 240 min. | | | |
| | Carfilzomib
2 mg/ml (2,000 ppm)
240 min. | > 240 min. | | | |
| | Carmustine
3.3 mg/ml (3,300 ppm)
21.1 (24.2, 21.1, 25.3)min. | 21.1 min | | | |
| | Cetuximab
2 mg/ml (2,000 ppm)
240 min. | > 240 min. | | | |
| | Chloroquine
50 mg/m (50,000 ppm)
240 min. | > 240 min. | | | |
| | Cisplatin
1 mg/ml(1,000 ppm)
240 min. | > 240 min. | | | |
| | Cladribine
1 mg/ml (1000 ppm)
240 min. | > 240 min. | | | |
| | Cyclophosphamide
20 mg/ml (20.000 ppm)
240 min. | > 240 min. | | | |
| | Cyclosporin A
100 mg/ml (100,000 ppm)
240 min. | > 240 min. | | | |
| | Cytarabine(Cytosine)
100.0 mg/ml (100,000 ppm)
240 min. | > 240 min. | | | |
| | Cytovene(Ganciclovir)
10 mg/ml(10,000 ppm)
240 min. | > 240 min. | | | |
| | Dacarbazine
10 mg/ml(10,000 ppm)
240 min. | > 240 min. | | | |
| | | Daunorubicin HCI
5 mg/ml (5,000 ppm)
240 min. | Decitabine
5 mg/ml(5,000 ppm)
240 min. | > 240 min. | > 240 min. |
| | Docetaxel
10 mg/ml (10.000 ppm)
240 min. | > 240 min. | | | |
| | Doxorubicin HCI
2 mg/ml (2,000 ppm)
240 min. | > 240 min. | | | |
| | Epirubicin HCI (Ellence)
2 mg/ml (2,000 ppm)
240 min. | > 240 min. | | | |
| | Etoposide
20 mg/ml (20,000 ppm)
240 min. | > 240 min. | | | |
| | Fludarabine
25.0 mg/ml (25,000 ppm)
240 min. | > 240 min. | | | |
| | Fluorouracil | > 240 min. | | | |
| | 50 mg/ml,(50,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Fulvestrant | > 240 min. | | | |
| | 50 mg/ml(50,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Gemcitabine | > 240 min. | | | |
| | 38 mg/ml (38,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Idarubicin HCL | > 240 min. | | | |
| | 1.0 mg/ml (1,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Ifosfamide | > 240 min. | | | |
| | 50 mg/ml (50,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Irinotecan HCI | > 240 min. | | | |
| | 20 mg/ml (20,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Mechlorethamine HCI | > 240 min. | | | |
| | 1 mg/ml(1,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Melphalan | > 240 min. | | | |
| | 5 mg/ml(5000 ppm) | | | | |
| | > 240 min. | | | | |
| | Methotrexate | > 240 min. | | | |
| | 25 mg/ml (25,000 ppm) | | | | |
| | > 240 min. | | | | |
| | MESNA | > 240 min. | | | |
| | 100 mg/ml(100,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Mitomycin C | > 240 min. | | | |
| | 0.5 mg/ml (500 ppm) | | | | |
| | > 240 min. | | | | |
| | Mitoxantrone HCL | > 240 min. | | | |
| | 2 mg/ml (2,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Oxaliplatin | > 240 min. | | | |
| | 5 mg/ml (5,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Paclitaxel | > 240 min. | | | |
| | 6 mg/ml (6,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Paraplatin | > 240 min. | | | |
| | 10 mg/ml (10,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Pemetrexed | > 240 min. | | | |
| | 25 mg/ml (25,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Raltitrexed | > 240 min. | | | |
| | 0.5 mg/ml (500 ppm) | | | | |
| | > 240 min. | | | | |
| | Retrovir | > 240 min. | | | |
| | 10 mg/ml(10,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Rituximab | > 240 min. | | | |
| | 10 mg/ml (10,000 ppm) | | | | |
| | > 240 min. | | | | |
| | Temsirolimus | > 240 min. | | | |
| | 25 mg/ml (25,000 ppm) | | | | |
| | > 240 min. | | | | |
| | | Thiotepa | 10 mg/ml(10,000 ppm) | 74.9 min. | |
| | 74.9 (74.9, 96.7, 79.0)min. | | | | |
| | Topotecan | > 240 min. | | | |
| | 1 mg/ml (1,000 ppm) | | | | |

Table 1 Summary of Non-Clinical Testing

16

Image /page/16/Picture/1 description: The image contains a logo for "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "/" repeated inside. To the right of the square, the words "ZHONGHONG" are stacked on top of the word "PULIN". The text is in a simple, sans-serif font.

17

Image /page/17/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of two parts: a red square with the letters "Z" and "Z" separated by a vertical line, and the company name written in black text to the right of the square. The company name is written in two lines, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.

18

Image /page/18/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" and a vertical line separating them. To the right of the square are the words "ZHONGHONG" in a larger font and "PULIN" in a smaller font below it. The text is in a sans-serif font and is black.

	> 240 min.	> 240 min.
Triclosan
3 mg/ml(3,000 ppm)

240 min. | | > 240 min. |
| Trisenox (Arsenic Trioxide)
1 mg/ml (1,000 ppm)
240 min. | | > 240 min. |
| Vinblastine,
1 mg/ml (1,000 ppm)
240 min. | | > 240 min. |
| Vincristine sulfate (Oncovin)
1 g/ml (1,000 ppm)
240 min. | | > 240 min. |
| Vinorelbine
10 mg/ml(10,000 ppm)
240 min. | | > 240 min. |
| Zoledronic Acid
1 mg/25ml (40 ppm)
240 min. | | > 240 min. |
| Fentanyl Citrate Injection
100mcg/2mL
240 min. | | > 240 min. |

9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicate device K193555.