Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

K220250 · Grand Work Plastic Products Co., Ltd. · LZA · May 11, 2022 · General Hospital

Device Facts

• Record ID: K220250
• Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.

Device Story

Disposable sterile nitrile examination glove; blue color; powder-free. Worn by clinicians on hands/fingers to prevent cross-contamination between patient and examiner. Tested for permeability against various chemotherapy drugs per ASTM D6978-05(2019). Used in clinical settings. Provides barrier protection; helps mitigate exposure to hazardous chemotherapy agents during handling.

Clinical Evidence

Bench testing only. Testing included physical dimensions (ASTM D6319-19), physical properties (tensile strength, elongation), freedom from holes (ASTM D5151-19), residual powder (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility testing confirmed no skin irritation, no sensitization, and no acute systemic toxicity per ISO 10993-10 and ISO 10993-11.

Technological Characteristics

Material: Nitrile synthetic latex. Form: Sterile, powder-free, ambidextrous, blue. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D6978-05(2019) (chemotherapy permeation), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-10, ISO 10993-11. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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

• Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 11, 2022

Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K220250

Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 12, 2022 Received: February 17, 2022

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.

Clarence W. Murray, III, PhD 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) K220250

#### Device Name

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.

| Chemotherapy Drug | Minimum BDT (Minutes) |
|-----------------------------------------------------------------|-----------------------|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 196.7 |
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Please note that the following drugs have low permeation times: | |
| Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes | |

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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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

### 510(K) SUMMARY

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR \$807.92.

The assigned 510(K) number is: K220250

Date Prepared: January 20, 2022

1. Owner's Identification:

Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: [phone]

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone]

#### 2. Name of the Device:

Trade Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA and LZC Device Class: Class I

### 3. Predicate Device Information:

Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)

#### 4. Device Description:

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).

#### 5. Indications for Use:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs and provides protection against following chemotherapy drugs and the minimum breakthrough time are listed as follows.

| Chemotherapy Drug | Minimum BDT (Minutes) |
|-------------------------------------|-----------------------|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

| Thiotepa (10mg/ml) | 196.7 |
|---------------------------------|-------|
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes

### 6. Specification for Nitrile Gloves:

| Items | Acceptance Criteria | Results |
|----------------------------------------------|----------------------|---------------------------------------|
| Length | Minimum 230mm | All size ≥290 |
| Palm Width | XS: 70±10mm | 76-78mm |
| | S: 80±10mm | 86-88 mm |
| | M:95±10mm | 96 -98mm |
| | L:110±10mm | 106-108 mm |
| | XL: 120±10mm | 116-118 mm |
| | XXL: 130±10mm | 126-128 mm |
| Thickness | Palm: 0.05mm (min) | 0.09-0.11mm |
| | Finger: 0.05mm (min) | 0.13-0.14mm |
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5<br>requirements |
| Powder-Content | ≤2 mg per glove | ≤ 2 mg, meet requirements |

Gloves meet all the specification listed in ASTM D 6319-19.

### 7. Technological Characteristic Comparison:

| Characteristics | Subject Device | Predicate Device K190725 | Comparison |
|-------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------|
| Trade Name | Sterile Powder Free Nitrile<br>Examination Gloves (Blue), Tested<br>for Use with Chemotherapy Drugs | Nitrile Examination Gloves<br>Sterile Tested for Use with<br>Chemotherapy Drugs claim, White | Similar |
| Product Code | LZA and LZC | LZA and LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

| Class | I | I | Same |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for Use | Subject device is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | Predicate device is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | Same |
| Description | Sterile Examination glove made of<br>Nitrile and color Blue and tested<br>with chemotherapy Drugs | Sterile Examination glove made of<br>Nitrile and color White and tested with<br>chemotherapy Drugs | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | White | Different |
| Sterility ISO 11737-2<br>EN ISO 11137-2 | Sterility | Sterility | Same |
| Single used | Single used | Single used | Same |
| Non Sterile or Sterile | Sterile | Sterile | Same |
| 10993-10:2010 Skin<br>Irritation Study | Under the conditions of the<br>study, not an irritant | Under the conditions of the study,<br>not an irritant | Same |
| 10993-10:2010<br>Maximization Sensitization<br>Study | Under the conditions of the<br>study, not a sensitizer | Under the conditions of the study,<br>not a sensitizer | Same |
| ISO 10993 Part 11<br>Acute Systemic Toxicity<br>Test | Under the conditions of this study,<br>there was no evidence of systemic<br>toxicity. | Under the condition of this study,<br>Nitrile Examination glove, sterile<br>shows no adverse biological reaction | Same |

### Dimensions and Performance Comparison Table:

| Technological<br>Characteristics | Subject Device | Predicate Device<br>K190725 | Comparison |
|--------------------------------------|----------------|-----------------------------|------------|
| Length | Minimum 230mm | Minimum 230mm | Same |
| 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 | / | 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 |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

| Tensile Strength, After<br>Accelerated Aging | 14MPa, min | 14MPa, min | Same |
|-------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------|
| Ultimate Elongation, After<br>Accelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with ASTM D<br>5151-19, following ASTM<br>D6319- 19, G-I, AQL 2.5 | In accordance with ASTM D<br>5151-19, following ASTM<br>D6319- 19, G-I, AQL 2.5 | Same |
| Residual Powder | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |

Chemotherapy Permeation Comparison:

| Tested Chemotherapy Drug and<br>Concentration | Minimum BDT (Minutes) | | Comparison |
|-----------------------------------------------|-----------------------|-----------------------------|------------|
| | Subject Device | Predicate Device<br>K190725 | |
| Carmustine (BCNU) (3.3mg/ml) | 54.3 | 39 | Similar |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Cytarabine (1.0 mg/ml) | / | >240 | Different |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 196.7 | 97.6 | Similar |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | / | Exceed |
| Vincristine Sulfate (1.0 mg/ml) | >240 | / | Exceed |
| Cytarabine HCL (100mg/ml) | >240 | / | Exceed |
| Mitoxantrone (2.0 mg/ml) | >240 | / | Exceed |
| Mitomycin C (0.5 mg/ml) | >240 | / | Exceed |
| Ifosfamide (50.0 mg/ml) | >240 | / | Exceed |
| Dacarbazine (10.0 mg/ml) | >240 | / | Exceed |

### 8 Summary of Non-Clinical Testing

Non-clinical tests were performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:

| Test Methodology | Purpose | Acceptance<br>Criteria | Result Summary |
|------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------|
| ASTM D6319-19 | The purpose of the testing is to<br>measure the dimensions of the<br>subject device. | XS-70±10<br>S-80±10<br>M-95±10<br>L-110±10<br>XL-120±10<br>XXL-130±10 | Meets |
| ASTM D6319-19 | The purpose of the testing is to<br>measure the physical properties of | Finger - Minimum 0.05 | Meets |

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#

ggao Industrial Zone, Zanhuang, Hebei, 050000, China

| | the subject device. | Palm - Minimum 0.05 | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------|
| | | Tensile Strength, before aging -<br>14MPa, min | |
| | | Ultimate Elongation, Before Aging -<br>500%, min | |
| | | Tensile Strength, After Accelerated<br>Aging - 14MPa, min | |
| | | Ultimate<br>Elongation, After<br>Accelerated<br>Aging - 400%,<br>mi | |
| ASTM D6319- 19<br>ASTM D5151-19 | The purpose of the testing is to<br>measure the freedom from holes of<br>the subject device. | In accordance with ASTM D<br>5151-19, following ASTM<br>D6319- 19, G-I,<br>AQL 2.5 | Meets |
| ASTM D 6124-06(2017)<br>ASTM D6319- 19 | The purpose of the testing is to<br>measure the residual powder on the<br>subject device. | ≤2 mg per glove | Meets |
| ISO 10993-10:2010 | The purpose of the testing is to<br>measure the primary skin irritation<br>test of the subject device. | Under the conditions of the study the<br>device extracts were not an irritant | Meets |
| ISO 10993-10:2010 | The purpose of the testing is to<br>measure the Dermal sensitization<br>assay of the subject device. | Under the conditions of the study<br>the device extracts were not a<br>sensitizer | Meets |
| ISO 10993-11:2017 | The purpose of the testing is to<br>measure the Acute Systemic<br>Toxicity of the subject device. | Under the conditions of this study,<br>there was no evidence of systemic<br>toxicity for the device extracts. | Meets |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

The subject device meets the applicable requirements for patient examination gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 and ISO 10993-11.

### 9. Conclusion:

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