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

K230662 · Zhonghong Pulin Medical Products Co., Ltd. · LZA · Oct 26, 2023 · General Hospital

Device Facts

• Record ID: K230662
• Device Name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
• Applicant: Zhonghong Pulin Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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 Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; extended cuff (min 270mm). Used by healthcare professionals in clinical settings to prevent cross-contamination. Tested for permeation resistance against chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Input: physical contact with patient/drugs. Output: barrier protection. Clinical decision-making: provides protection during handling of hazardous drugs; prevents patient-examiner contamination. Benefit: reduces exposure risk to hazardous substances and pathogens.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility (ISO 10993-5, 10993-10) and physical performance (ASTM D6319, D5151, D6124) demonstrated compliance. Permeation testing (ASTM D6978-05) confirmed resistance to chemotherapy drugs and Fentanyl Citrate, with specific breakthrough times reported.

Technological Characteristics

Material: Nitrile compounds. Form factor: Ambidextrous, blue, powder-free, extended cuff (min 270mm). Standards: ASTM D6319 (physical properties), ASTM D5151 (holes), ASTM D6124 (residual powder), ASTM D6978-05 (chemotherapy permeation). Sterility: Non-sterile. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or fingers to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs, Fentanyl Citrate, and select other drugs. Contraindicated for use with Carmustine and Thiotepa.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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.

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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

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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) 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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Image /page/5/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 "/" repeated inside, 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.

# 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)<br>number | Nitrile Exam Glove, Extended cuff,<br>Tested For Use With<br>Chemotherapy Drugs, Fentanyl<br>Citrate, And Select Other Drugs | Disposable Powder Free Nitrile<br>Examination Glove, Blue Color,<br>Tested For Use With Chemotherapy<br>Drugs And Fentanyl Citrate | / |
| Product<br>Code | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar |
| Regulation<br>No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indications<br>For Use | A patient examination gloves is a<br>disposable device intended for medical<br>purpose that is worn on the examiner's<br>hand or fingers to prevent | A patient examination gloves is a<br>disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand or fingers to | Similar |
| contamination between patient and examiner.<br>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.<br>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.<br>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)<br>> 240 | 26 Fluorouracil (50.0 mg/ml) > 240 | 27 Fulvestrant (50.0 mg/ml) > 240 |
| Idarubicin HCL 1.0 mg/ml (1,000 ppm)<br>> 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

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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.

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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<br>Concentration Breakthrough<br>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<br>Carmustine and Thiotepa.<br>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<br>Thiotepa, 10.0 mg/ml 13.6 minutes |
| | Fentanyl Permeation Resistance<br>Claim - Under the testing conditions<br>of ASTM D6978-05, Fentanyl Citrate<br>Injection (100mcg/2mL) was found<br>to have no breakthrough detected<br>up to 240 minutes. |

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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<br>Carmustine (3.3 mg/ml), 74.9 minutes<br>with Thio Tepa (10 mg/ml).<br>Warning: Do not use with Carmustine<br>and Thiotepa. | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|
| Powdered or<br>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<br>device<br>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<br>with ASTM<br>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<br>Device<br>(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<br>with ASTM<br>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<br>K230662 | Predicate device<br>(K193555) | Remark |
|------|---------------------------|-------------------------------|--------|
|------|---------------------------|-------------------------------|--------|

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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<br>Properties | | | Comply with ASTM<br>D6319 | Comply with ASTM<br>D6319 | Same | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------|---------|------------|-----------------------------------------------|------|
| | Before<br>Aging | Tensile<br>Strength | (19.9-28.9)MPa | 14MPa, min | Same | | | |
| | | Criteria | 14MPa, min | 14MPa, min | | | | |
| | | Results | Pass | Pass | | | | |
| | | Ultimate<br>Elongation | (540-580)% | 500% min | Same | | | |
| | | Criteria | 500% min | 500% min | | | | |
| | | Results | Pass | Pass | | | | |
| | After<br>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<br>ASTMD5151 | accordance with<br>ASTMD5151 | Same | | | |
| | | Criteria | AQL: 2.5 (ISO 2859) | G-1, AQL 2.5 | | | | |
| | | Results | 0 gloves of failure<br>Pass | Pass | | | | |
| Powder Content | | | Meet the requirements of<br>ASTM D6319 | Meet the requirements of<br>ASTM D6319 | Same | | | |
|…