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

K232039 · Grand Work Plastic Products Co., Ltd. · LZA · Aug 9, 2023 · General Hospital

Device Facts

• Record ID: K232039
• Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 9, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The 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 fentanyl citrate in accordance with ASTM D6978.

Device Story

Sterile, powder-free, blue nitrile examination glove; ambidextrous; available in sizes XS to XXL. Device acts as a physical barrier to prevent contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978. Used in clinical settings by healthcare professionals. Provides protection against chemical exposure during handling of hazardous drugs.

Clinical Evidence

No clinical data. Bench testing only, including physical dimensions, tensile strength, elongation, freedom from holes, powder residue, and chemical permeation testing per ASTM D6978. Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Nitrile compound; powder-free; sterile; ambidextrous; blue color. Dimensions and physical properties comply with ASTM D6319-19. Permeation testing per ASTM D6978-05(2019).

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 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

• Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for 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.

September 6, 2023

Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China

Re: K232039

Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), 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, QDO, OPJ

Dear Wu Yuli:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on August 9, 2023. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-2261, or Bifeng. [e-mail].

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

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Image /page/1/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services logo. The second logo is the FDA U.S. Food & Drug Administration logo.

Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China

#### Re: K232039

Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), 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: July 5, 2023 Received: July 10, 2023

#### Dear Wu Yuli:

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.

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

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

Sincerelv.

# Allan-Guan -S

For 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) K232039

#### Device Name

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

Indications for Use (Describe)

The 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 fentanyl citrate in accordance with ASTM D6978.

| 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 |

Minimum BDT (Minutes) Opioid Drug Fentanyl Citrate Injection (100mcg/2mL) >240 Caution: 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

#### 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.

The assigned 510(K) number is: K232039

Date Prepared: August 09, 2023

#### 1. Owner's Identification:

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

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

#### 2. Name of the Device:

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

#### 3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250) Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC Device Class: Class I

#### 4. Device Description:

The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).

Specification for subject device: Acceptance Criteria Results Items Length Minimum 230mm All size ≥290 XS: 70±10mm 76-78mm Palm Width S: 80±10mm 86-88 mm

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| | 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 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.

#### 5. Device Modification

The proposed modification to the predicate device is add the claim which tested for use with fentanyl citrate besides claim use with Chemotherapy drugs. We have tested the proposed device (exactly same as predicate device) for use with fentanyl citrate as per ASTM D6978 and gotten the testing report to support this claim. Please note that there are no any differences with these two gloves from materials, manufacturing process and bench performance.

#### 6. Indications for Use:

The 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 fentanyl citrate in accordance with ASTM D6978.

| 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 |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| Opioid Drug | Minimum BDT (Minutes) |
|-----------------------------------------|-----------------------|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |

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

#### 7. Comparison of Technological Characteristics Between the Subject Device and Predicate Device:

| Items | Predicate Device<br>K220250 | Subject Device<br>K232039 | Result of<br>comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Trade Name | Sterile Powder Free Nitrile<br>Examination Gloves (Blue),<br>Tested for Use with<br>Chemotherapy Drugs | Sterile Powder Free Nitrile<br>Examination Gloves (Blue),<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Different* |
| Product Code | LZA, LZC | LZA, LZC, OPJ, QDO | Different* |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Description | Sterile Examination glove | Sterile Examination glove | Same |
| Indications for Use | Sterile Powder Free Nitrile<br>Examination Gloves (Blue),<br>Tested for Use with<br>Chemotherapy Drugs is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. In addition<br>these gloves were tested for use<br>with Chemotherapy drugs in<br>accordance with ASTM D6978. | The glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. In<br>addition these gloves were<br>tested for use with<br>Chemotherapy drugs and<br>fentanyl citrate in accordance<br>with ASTM D6978. | Different* |
| Powder or Powder<br>Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Sterility | Sterile | Sterile | Same |
| Single use | Single use | Single use | Same |
| Chemotherapy<br>Drug Permeation<br>Claim | See below comparison table | See below comparison table | / |

*This different is support with test report and will be indicated on labeling.

Chemotherapy Permeation Comparison Claim:

| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | | Result of<br>comparison |
|--------------------------------------------|-----------------------------|---------------------------|-------------------------|
| | Predicate Device<br>K220250 | Subject Device<br>K232039 | |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| Carmustine (BCNU) (3.3mg/ml) | 54.3 | 54.3 | Same |
|-------------------------------------|-------|-------|------|
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| 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 | 196.7 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 | Same |
| Cytarabine HCL (100mg/ml) | >240 | >240 | Same |
| Mitoxantrone (2.0 mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Ifosfamide (50.0 mg/ml) | >240 | >240 | Same |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 | Same |

| Opioid Drug and Concentration | Minimum BDT (Minutes) | | Result of<br>comparison |
|-----------------------------------------|-----------------------------|---------------------------|-------------------------|
| | Predicate Device<br>K220250 | Subject Device<br>K232039 | |
| Fentanyl Citrate Injection (100mcg/2mL) | / | >240 | Different* |

*This different is support with test report and will be indicated on labeling.

#### Dimensions and Performance Comparison Table:

| Technological | Subject Device | Predicate Device | Remark |
|--------------------------|---------------------------|---------------------------|--------|
| Characteristics | K232039 | K220250 | |
| 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 | 130±10 | Same |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before | 14MPa, min | 14MPa, min | Same |
| Aging | | | |
| Ultimate Elongation, | 500%, min | 500%, min | Same |
| Before Aging | | | |
| Tensile Strength, After | 14MPa, min | 14MPa, min | Same |
| Accelerated Aging | | | |
| Ultimate Elongation, | 400%, min | 400%, min | Same |
| After Accelerated Aging | | | |
| Freedom from holes | In accordance with ASTM D | In accordance with ASTM D | Same |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| | 5151-19, following ASTM<br>D6319-19, G-I, AQL 2.5 | 5151-19, following ASTM<br>D6319-19, G-I, AQL 2.5 | |
|-----------------|---------------------------------------------------|---------------------------------------------------|------|
| Residual Powder | ≤2 mg per glove | ≤2 mg per glove | Same |

#### 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:

| Referenced standards | Test Performed/Prupose | Acceptance Criteria | Results |
|----------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XS<br>and S, 230mm for size M, L, XL | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm<br>Width | XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L:110±10mm<br>XL: 120±10mm<br>XXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min)<br>Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19<br>ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min14 Mpa)<br>and Elongation (Before Aging<br>500% and after aging 400%) Min | Pass |
| ASTM D6319- 19<br>ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19<br>ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, Opioid<br>Drug Permeation | Refer the above tables | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin<br>irritation | Is non-<br>sensitization and<br>Non-irritation |
| ISO 10993-11:2017 | Acute systemic toxicity<br>study | Subject showed no adverse<br>biological reaction | no evidence of<br>acute systemic<br>toxicity. |

#### 8. Summary of Clinical Information:

No clinical testing was submitted for the subject device.

#### 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 predicate device.