POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

K163146 · Hebei Hongsen Plastics Technology Co, Ltd. · LZC · Feb 13, 2017 · General Hospital

Device Facts

• Record ID: K163146
• Device Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
• Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
• Product Code: LZC · General Hospital
• Decision Date: Feb 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile patient examination glove; worn by clinicians to provide barrier protection against contamination between patient and examiner. Device tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; non-sterile. Provides physical barrier; protects healthcare workers from exposure to hazardous chemotherapy agents. Benefits include reduced risk of cross-contamination and chemical exposure.

Clinical Evidence

Bench testing only. No clinical data. Compliance verified via ASTM D6319-10 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy drug permeation), and ISO 10993-10:2010 (irritation and sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ASTM D6978-05, ISO 2859-1, ISO 10993-10. Dimensions: Length 230mm, varying widths/thicknesses per size.

Indications for Use

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

• Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs (K141982)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of three human profiles facing to the right, layered on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 13, 2017

Hebei Hongsen Plastics Technology Co, Ltd % Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd.,liyuan, Tongzhou District Beijing, 101121 CN

Re: K163146 Trade/Device Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 3. 2017 Received: January 9, 2017

Dear Ray 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 (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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D.

Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K163146

### Device Name

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

| The following chemicals have been tested with proposed device. | | |
|----------------------------------------------------------------|-------------------------|----------------------------------------|
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cyclophosphamid (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 45.0 |
| *Thiotepa | 10.0 mg/ml (10,000 ppm) | 30.0 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCL | 1.0 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | > 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |

* Please note that the following drugs have low permeation times: Carmustine (BCNU): 45 minutes and Thiotepa: 30 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163146

- 1. Date of Preparation: 02/08/2017
- 2. Sponsor Identification

# HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA

Contact Person: Mr. ShaoZhang Nan Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

## Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Proposed Device Identification

Trade Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Device Name: NITRILE Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

### Regulatory Information

Classification: I Product Code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

#### Indication for Use:

The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with proposed device.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---------------------------|-------------------------|----------------------------------------|
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cyclophosphamid (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 45.0 |
| *Thiotepa | 10.0 mg/ml (10,000 ppm) | 30.0 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCL | 1.0 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | > 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |

*Please note that the following drugs have low permeation times:

Carmustine (BCNU): 45 minutes and Thiotepa: 30 minutes

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- 5. Predicate Device Identification
510(k) Number: K141982

Product Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs

Manufacturer: WRP Asia Pacific Sdn Bhd.

- Device Description 6.
The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes

The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.

The proposed device was tested according to the following standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05. These standards are identified in the following section "Non-clinical test conclusion.

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all specifications and the proposed device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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| Item | Proposed Device<br>POWDER FREE Blue Nitrile<br>GLOVES, Tested for Use with<br>Chemotherapy Drugs<br>(K163146) | Predicate Device<br>Dermagrip Powder Free Blue Nitrile<br>Patient Examination Gloves Tested for<br>Use with Chemotherapy Drugs<br>(K141982) | Remark | | | | Size | | | | | |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------|-------------------|--|------|-----|-----|-----|-----|-----------|
| Product Code | LZA, LZC | LZA, LZC | Same | Proposed Device | Designation | | XS | S | M | L | XL | Tolerance |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | POWDER FREE Blue Nitrile GLOVES, Tested for Use<br>with Chemotherapy Drugs<br>(K163146) | Length, mm | | 230 | 230 | 230 | 230 | 230 | min |
| Class | I | I | Same | | Width, mm | | 70 | 80 | 95 | 110 | 120 | ±10 |
| Indication for use | The POWDER FREE Blue Nitrile<br>GLOVES, Tested for Use with<br>Chemotherapy Drugs is a disposable<br>device intended for medical purposes<br>that is worn on the examiner's hands<br>to prevent contamination between<br>patient and examiner. | A patient examination glove is a<br>disposable device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Same | | Thickness, mm: | | | | | | | |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same | | Finger | | 0.10 | | | | | ±0.03 |
| Design Feature | ambidextrous | ambidextrous | Same | | Palm | | 0.08 | | | | | ±0.03 |
| Labeling<br>Information | Single-use indication, powder free,<br>device name, glove size and quantity,<br>Nitrile Examination Gloves,<br>Non-Sterile | Single-use indication, powder free,<br>device name, glove size and quantity,<br>Nitrile Examination Gloves,<br>Non-Sterile | Same | | Cuff | | 0.06 | | | | | ±0.03 |
| Chemotherapy Drug<br>Permeation Claim | Fluorouracil, Etoposide (Toposar),<br>Cyclophosphamid (Cytoxan),<br>Carmustine (BCNU), Thiotepa,<br>Paclitaxel (Taxol), Doxorubicin<br>Hydrochloride, Dacarbazine (DTIC),<br>Cisplatin, Carboplatin, Docetaxel,<br>Ifosfamide, Irinotecan,<br>Mechlorethamine HCL,<br>Methotrexate, Mitomycin C,<br>Mitoxantrone, Vincristine Sulfate | Fluorouracil, Etoposide (Toposar),<br>Cyclophosphamid (Cytoxan),<br>Carmustine (BCNU), Thiotepa,<br>Paclitaxel (Taxol), Doxorubicin<br>Hydrochloride, Dacarbazine (DTIC),<br>Cisplatin, Ifosfamide, Mitoxantrone,<br>Vincristine Sulfate | Analysis 1 | Predicate Device | Size: Min. 240 mm | | | | | | | |
| Dermagrip Powder Free Blue Nitrile Patient<br>Examination Gloves Tested for Use with Chemotherapy<br>Drugs<br>(K141982) | Thickness: Finger (0.07-0.10); Palm(0.07-0.09); Cuff (0.06-0.08) | | | | | | | | | | | |
| Remark | Analysis 2 | | | | | | | | | | | |

#### 8. Substantially Equivalent (SE) Comparison Conclusion

Table 1 General Comparison

Analysis 1:

The proposed and predicate devices both have a tested for use with chemotherapy drugs claim. However, different chemotherapy drugs have been tested for the proposed device and the results meet the specifications of ASTM D6978

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### Table 2 Device Dimensions Comparison

Analysis 2:

The proposed device has different size specification as compared to the predicate device, but the proposed device meets the specifications of ASTM D6319.

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| Item | | | Proposed Device<br>POWDER FREE Blue Nitrile GLOVES,<br>Tested for Use with Chemotherapy Drugs<br>(K163146) | Predicate Device<br>Dermagrip Powder Free<br>Blue Nitrile Patient<br>Examination Gloves Tested<br>for Use with Chemotherapy<br>Drugs<br>(K141982) | Remark |
|------------------------|-----------------|------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Colorant | | | Blue | Blue | Same |
| Physical<br>properties | Before<br>Aging | Tensile<br>Strength | 15 Mpa, min | Meet the Requirements of<br>ASTM D 6319 | Analysis 3 |
| | | Ultimate<br>Elongation | 500% min | Meet the Requirements of<br>ASTM D 6319 | |
| | After<br>Aging | Tensile<br>Strength | 14 MPa, min | Meet the Requirements of<br>ASTM D 6319 | |
| | | Ultimate<br>Elongation | 400% min | Meet the Requirements of<br>ASTM D 6319 | |
| | | | Comply with ASTM D6319 | Comply with ASTM D6319<br>14 MPa. Min/500% min.<br>before aging;<br>14 MPa. Min./400% min.<br>After aging | Same |
| Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151<br>AQL 1.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151<br>under AQL 2.5/Inspection<br>Level G-I | Same |
| Powder Content | | | Max. 0.32 mg per glove | Meet the requirements of<br>ASTM D6319<br>Less than 2mg per glove | Same |

Table 3 Performance Comparison

Analysis 3:

The proposed device has a different Ultimate Elongation after aging as compared to the predicate device, but the proposed device meets the specifications of ASTM D6319.

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| Item | Proposed Device<br>POWDER FREE Blue<br>Nitrile GLOVES, Tested for<br>Use with Chemotherapy<br>Drugs<br>(K163146) | Predicate Device<br>Dermagrip Powder Free Blue Nitrile<br>Patient Examination Gloves Tested for Use<br>with Chemotherapy Drugs<br>(K141982) | Remark | |
|--------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation | Under the conditions of the<br>study, not an irritant | Comply with ISO 10993-10 | Same |
| | Sensitization | Under the conditions of the<br>study, not a sensitizer | | |
| Label and Labeling | Meet FDA's<br>Recommendations | Meet FDA's Recommendations | Same | |

### Table 4 Safety Comparison

#### 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs.