Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K230779 · Shanxi Hongjin Plastic Technology Co., Ltd. · LZA · Jun 9, 2023 · General Hospital

Device Facts

• Record ID: K230779
• Device Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; available in sizes XS to XXL. Designed to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019). Used in clinical settings by healthcare professionals. Provides a physical barrier; protects the wearer from exposure to hazardous drugs. Warning: Do not use with Carmustine or Thiotepa due to low breakthrough detection times.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (physical dimensions, tensile strength, elongation), ASTM D5151-19 (watertightness), ASTM D6124-06 (powder residue), and ASTM D6978-05(2019) (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-5, -10, -11, and -23.

Technological Characteristics

Material: Nitrile. Form: Powder-free, ambidextrous, black. Sizes: XS-XXL. Standards: ASTM D6319-19 (dimensions/properties), ASTM D5151-19 (watertightness), ASTM D6124-06 (powder residue), ASTM D6978-05(2019) (chemotherapy permeation). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10/23 (sensitization/irritation), ISO 10993-11 (systemic toxicity). Tensile strength: 14 MPa (min). Elongation: 500% (before aging), 400% (after aging).

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and Fentanyl Citrate.

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

• Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 9, 2023

Shanxi Hongjin Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K230779

Trade/Device Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: March 20, 2023 Received: March 21, 2023

Dear Kathy Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

# Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230779

Device Name

Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentany) Citrate

Indications for Use (Describe)

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|------------------------------------------|------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province

## 510(K) SUMMARY

The assigned 510(K) numbers: K230779 Date Prepared: June 08, 2023

### 1. Owner's Identification:

Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province Email: fdareg(@hongray.com.cn

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: [phone] Email: [e-mail]

#### 2. Name of the Device:

Trade / Product Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I

#### 3. Predicate Device Information:

Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

#### 4. Device Description:

Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

#### 5. Indications for Use:

The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:

> K230779 । । ર

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province

| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in<br>Minutes |
|------------------------------------------|---------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |

* Please note that the following drugs have extremely low permeation times: Carmustine: 11.3 minutes, Thiotepa: 24.7minutes, Or

*Warning: Do not use with Carmustine and Thiotepa.

## 6. Comparison of Subject Device and Predicate Device:

| | Subject Device<br>K230779 | Predicate Device<br>K192954 | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Powder Free Nitrile<br>Examination Gloves (Black),<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Blue Colored, Power Free Nitrile<br>Examination Gloves Tested for<br>Use with Chemotherapy Drugs and<br>Fentanyl Citrate | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free Nitrile Examination<br>Gloves (Black), Tested for Use<br>with Chemotherapy Drugs and<br>Fentanyl Citrate is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. Gloves have been<br>tested for use with chemotherapy<br>drugs and Fentanyl Citrate using<br>ASTM D6978 | Blue Colored, Powder Free Nitrile<br>Examination Gloves, Non-sterile,<br>and Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate is a patient medical exam<br>glove which is a disposable device<br>intended for medical purpose that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between examiner and patient.<br>Glove was tested for use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate as per ASTM D6978 | Similar |

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Linfen City, Linfen City, Shanxi Province

| Material | Nitrile | Nitrile | Same |
|-----------------------------------------------------|----------------------------|----------------------------|----------------------------------|
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Black | Blue | Different |
| Single use | Single use | Single use | Same |
| Chemotherapy Drugs<br>and Fentanyl Citrate<br>Claim | See below comparison table | See below comparison table | See below<br>comparison<br>table |

## Technological Characteristic Comparison Table:

| Technological<br>Characteristics | Subject Device<br>K230779 | Predicate Device<br>K192954 | Comparison |
|---------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------|------------|
| Length | Minimum 230mm | Minimum 240mm | Similar |
| Palm Width (size) (mm) | | | |
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | Different |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,<br>Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, After<br>Accelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151<br>AQL 2.5 | 21 CFR 800.20<br>ASTM D5151<br>AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Same |
| 10993-23:2021 Skin Irritation<br>Study | Under the conditions of<br>the study, not an irritant | Under the conditions of the<br>study, the subject device is<br>non-irritating | Same |
| 10993-10:2021 Maximization<br>Sensitization Study | Under the conditions of the<br>study, not a sensitizer | Under the conditions of the<br>study, the subject device is<br>non sensitization | Same |

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province

| 10993-5:2009 Cytotoxicity<br>Test | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity to<br>L929 cells. | Exhibits severe cytotoxicity<br>reactivity at 100%, and 66%<br>extract concentrations and no<br>cytotoxicity reactivity at 44%,<br>30%, 20% and 15% extract<br>concentrations under the<br>condition of this test. | Similar |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO 10993-11:2017 Acute<br>Systemic toxicity study | Under the conditions of this<br>study, there was no evidence of<br>systemic toxicity. | Under the conditions of the<br>study, the subject showed no<br>adverse biological reaction. | Same |

Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:

| Tested Chemotherapy Drug and<br>Concentration | Minimum BDT (Minutes) | Comparison | |
|-----------------------------------------------|---------------------------|-----------------------------|-----------|
| | Subject Device<br>K230779 | Predicate Device<br>K192954 | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 | 18.2 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 | 57.3 | Similar |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |

#### 7. Summary of Non-Clinical Performance Data

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

| Methodology | Test Performed | Acceptance Criteria | Results |
|--------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------|---------|
| ASTM D6319- 19 | Physical Dimensions<br>Length | Minimum 230mm for all<br>sizes | Pass |
| ASTM D6319- 19 | Physical Dimensions<br>Palm Width | XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L:110±10mm<br>XL: 120±10mm XXL:<br>130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions<br>Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19<br>ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14<br>MPa) and Elongation<br>(Before Aging 500% and<br>after aging 400%) Min | Pass |

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province

| ASTM D6319-19<br>ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
|---------------------------------------|--------------------------------------|--------------------------------------------------|---------------------------------------------|
| ASTM D6319-19<br>ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by<br>Chemotherapy Drugs | Refer the above table | Pass |
| ISO 10993-10 &23:2021 | Irritation and Skin<br>Sensitization | Skin sensitization and Skin<br>irritation | Is non-sensitization<br>and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential<br>toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity<br>study | Subject showed no adverse<br>biological reaction | no evidence of<br>systemic toxicity. |

- 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 D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. .
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation. ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●

#### 8. Clinical Performance Data

N/A

#### 9. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.