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

K182600 · Better Care Plastic Technology Co., Ltd. · LZA · Nov 30, 2018 · General Hospital

Device Facts

• Record ID: K182600
• Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
• Applicant: Better Care Plastic Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.

Device Story

Disposable, ambidextrous, powder-free nitrile examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Device provides a barrier against chemotherapy drugs; tested for permeation resistance per ASTM D6978-05(2013). Used in clinical settings by healthcare professionals. Output is a physical barrier; protects the wearer from exposure to hazardous chemotherapy agents and prevents patient contamination. Benefits include reduced risk of chemical exposure and infection control.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (residual powder), and ASTM D6978 (chemotherapy drug permeation). Biocompatibility verified via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Nitrile rubber material; ambidextrous; powder-free; non-sterile. Dimensions: length min 230mm, palm width 70-120mm (size dependent), thickness min 0.05mm. Complies with ASTM D6319-10(2015) and ASTM D6978-05(2013).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use with chemotherapy drugs as specified in the labeling.

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 Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

November 30, 2018

Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Avenue, Chino, CA 91810, USA

Re: K182600

Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 16, 2018 Received: September 21, 2018

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -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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# Indications for Use

510(k) Number (if known) K182600

#### Device Name

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

| Indications for Use (Describe) | |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978 and will be labeled with a statement of |
| compliance and a summary of the testing results. | |
| Chemotherapy Drug Permeation | |
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |

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

Carmustine: 11.0 minutes and Thiotepa: 28.8 minutes

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

7 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

#### 510(K) SUMMARY

The assigned 510(K) numbers: K182600 Date Prepared: November 18, 2018

#### 1. Owner's Identification:

Mrs. Zhu Chunyan Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 0500000 Tel:[phone] Fax: [phone]

Contact: Ms. Kathy Liu, Project Manager or Ms Monica Yu Hongray USA Medical Products Inc. Address: 3973 Schaefer Avenue, Chino, CA 91810, USA Tel:[phone] Fax: [phone]

#### 2. Name of the Device:

Trade / Product Name: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) Common Name: Exam Gloves Classification Name: Non-powdered patient Examination Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC Classification Panel: General Hospital Device Class: Class I

#### 3. Predicate Device Information:

Central Medicare Sdn. Bhd. Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942)

#### 4. Device Description:

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large.

Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).

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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

#### 510(K) SUMMARY

#### 5. Indications for Use:

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) 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 using ASTM D6978-05(2013) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation

| Chemotherapy Drug | Minimum Breakthrough<br>Detection Time (Minutes) |
|------------------------------------|--------------------------------------------------|
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan (5.0mg/ml) | >240 |

The following chemicals have been tested with these gloves:

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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

#### 510(K) SUMMARY

| Mitomycin C, (0.5mg/ml) | >240 |
|----------------------------------|------|
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |

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

11.0 minutes and Thiotepa: 28.8 minutes

#### 6. Technological Characteristic Comparison Table:

The proposed device will be known as Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue).

The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.

| | Proposed Device K182600 | Predicate Device K173942 | Comparison |
|-------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Powder Free Nitrile<br>Examination Gloves,<br>Tested for Use with<br>Chemotherapy Drugs<br>(Blue) | Blue Non Sterile Powder<br>Free Nitrile Examination<br>Gloves Tested for Use<br>with Chemotherapy Drugs | Similar |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |

General Comparison Table:

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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

| 510(K) SUMMARY | | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for Use | Powder Free Nitrile<br>Examination Gloves,<br>Tested for Use with<br>Chemotherapy Drugs<br>(Blue) is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. | Blue Non Sterile Powder<br>Free Nitrile Examination<br>Gloves Tested for Use<br>with Chemotherapy Drugs<br>is a disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | Same |
| Powder or Powder<br>Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| Labeling<br>Informati<br>on | Single-use indication,<br>powder free, device name,<br>glove size, quantity,<br>Nitrile Examination<br>Gloves, Non Sterile | Single-use indication,<br>powder free, device name,<br>glove size, quantity,<br>Nitrile<br>Examination Gloves,<br>Non Sterile | Same |
| Chemotherapy<br>Drug<br>Permeation Claim | See below comparison<br>table | See below comparison table | Same |

#### Dimensions and Performance Comparison Table:

| Technological<br>Characteristics | Proposed<br>Device<br>K182600 | Predicate<br>Device<br>K173942 | Comparison |
|----------------------------------|-------------------------------|--------------------------------|------------|
| Length | Minimum<br>230mm | Minimum<br>230mm | Same |
| Palm Width (size) (mm) | | | |
| XS | $70\pm10$ | $70\pm10$ | Same |
| S | $80\pm10$ | $80\pm10$ | Same |
| M | $95\pm10$ | $95\pm10$ | Same |

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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

#### 510(K) SUMMARY

| L | 110±10 | 110±10 | Same |
|------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------|
| XL | 120±10 | 120±10 | Same |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | 0.10±0.03 | Similar |
| Palm | Minimum 0.05 | 0.08±0.03 | Similar |
| Tensile Strength, Before<br>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,<br>After Accelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with<br>ASTM D 5151-06,<br>following ASTM D6319-<br>10, G-1, AQL 2.5 | In accordance with<br>ASTM D 5151-06,<br>following ASTM D6319-<br>10, G-1, AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Similar |
| 10993-10:2010 Skin<br>Irritation Study | Under the conditions of<br>the study,<br>not an irritant | Under the conditions of<br>the study,<br>not an irritant | Same |
| 10993-10:2010<br>Maximization<br>Sensitization Study | Under the conditions of<br>the study,<br>not a sensitizer | Under the conditions of<br>the study,<br>not a sensitizer | Same |
| 10993-5:2009<br>Cytotoxicity Test | Under the conditions of<br>this study, not a cytotoxic<br>potential | Under the conditions of<br>this study, not a cytotoxic<br>potential | Same |

#### Chemotherapy Permeation Comparison:

| | Minimum BDT (Minutes) | | Comparison |
|-----------------------------------------------|-------------------------------|--------------------------------|------------|
| Tested Chemotherapy Drug<br>and Concentration | Proposed<br>Device<br>K182600 | Predicate<br>Device<br>K173942 | |
| Carmustine(BCNU) (3.3<br>mg/ml) | 11.0 | 12.4 | Similar |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Dacarbazine (DTIC) | >240 | >240 | Same |
| (10mg/ml) | | | |
| Doxorubicin Hydrochloride<br>(2mg/ml) | >240 | >240 | Same |
| Etoposide (Toposar)<br>(20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Paclitaxel (Taxol) (6mg/ml) | >240 | >240 | Same |
| Thiotepa (THT) (10mg/ml) | 28.8 | 24.4 | Similar |
| Bleomycin (15.0mg/ml) | >240 | >240 | Same |
| Busulfan (6.0mg/ml) | >240 | >240 | Same |
| Carboplatin, (10.0mg/ml) | >240 | >240 | Same |
| Chloroquine, (50.0mg/ml) | >240 | >240 | Same |
| Cyclosporin, (100.0mg/ml) | >240 | >240 | Same |
| Cytarabine, (100.0mg/ml) | >240 | >240 | Same |
| Daunorubicin, (5.0mg/ml) | >240 | >240 | Same |
| Docetaxel, (10.0mg/ml) | >240 | >240 | Same |
| Epirubicin (Ellence),<br>(2.0mg/ml) | >240 | >240 | Same |
| Fludarabine, (25.0mg/ml) | >240 | >240 | Same |
| Gemcitabine (Gemzar)<br>(38.0mg/ml) | >240 | >240 | Same |
| Idarubicin, (1.0mg/ml) | >240 | >240 | Same |
| Ifosfamide, (50.0mg/ml) | >240 | >240 | Same |
| Irinotecan, (20.0mg/ml) | >240 | >240 | Same |
| Mechlorethamine HCI,<br>(1.0mg/ml) | >240 | >240 | Same |
| Melphalan, (5.0mg/ml) | >240 | >240 | Same |
| Mitomycin C, (0.5mg/ml) | >240 | >240 | Same |
| Mitoxantrone, (2.0mg/ml) | >240 | >240 | Same |
| Oxaliplatin, (2.0mg/ml) | >240 | >240 | Same |
| Paraplatin, (10.0mg/ml) | >240 | >240 | Same |
| Retrovir, (10.0mg/ml) | >240 | >240 | Same |
| Rituximab, (10.0mg/ml) | >240 | >240 | Same |
| Topotecan HCL, (1.0mg/ml) | >240 | >240 | Same |
| Trisonex, (1.0mg/ml) | >240 | >240 | Same |
| Velcade (Bortezomib),<br>(1.0mg/ml) | >240 | >240 | Same |
| Vincristine, (1.0mg/ml) | >240 | >240 | Same |

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# 510(K) SUMMARY

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Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

#### 510(K) SUMMARY

#### 7. Summary Non-Clinical Testing

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

- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves For Medical Application.
- . ASTM D6978-05 (Reapproved 2013), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.

### 8. Summary of Clinical Testing

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.