POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

K140816 · Better Care Plastic Technology Co., Ltd. · LZA · Jul 8, 2014 · General Hospital

Device Facts

• Record ID: K140816
• 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: Jul 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Test Chemotherapy Drug and Concentration Average BDT Fluorouracil, 50.0mg/ml (50,000ppm) >240 min. Etoposide (Toposar), 20.0mg/ml (20,000ppm) >240 min. Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) >240 min. Carmustine (BCNU), 3.3mg/ml (3,300ppm) 2.3 min. Thiotepa, 10.0mg/ml (10,000ppm) 30.9 min. Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) >240 min. Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) >240 min. Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) >240 min. Cisplatin, 1.0mg/ml (1,000ppm) >240 min. Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Device Story

Disposable, non-sterile nitrile examination glove; blue color; intended for medical use to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Breakthrough detection times provided for nine specific drugs; users cautioned against use with Carmustine and Thiotepa due to rapid permeation. Used in clinical settings by healthcare providers. Benefits include protection against patient-to-examiner contamination and specific chemotherapy agents.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including ASTM D6319-10 (dimensions, physical properties, pinholes, residual powder), ISO 10993-10 (primary skin irritation, dermal sensitization), and ASTM D6978-05 (chemotherapy drug permeation).

Technological Characteristics

Material: Nitrile compound. Form factor: Disposable, non-sterile, powder-free glove. Standards: ASTM D6319-10 (physical/dimensional), ASTM D6978-05 (permeation), ISO 10993-10 (biocompatibility). Connectivity: None. Energy source: None. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable, non-sterile patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs; not for use with Carmustine or Thiotepa due to low breakthrough detection times.

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

• Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096)

Submission Summary (Full Text)

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

JUL 0 8 2014

)

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

#### 510 (K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 8807.92. ---

The assigned 510(K) number is: K140816

### l . Owner's Identification:

Ms. Zhu Chunyan Better Care Plastic Technology Co., Ltd Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000

Tel: [phone] Fax: [phone]

ﺮ Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone] Fax: [phone] Date Summary Prepared: June 18, 2014

#### 2. Name of the Device:

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

Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I

#### 3. Predicate Device Information:

Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096)

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

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

#### 4. Device Descrintion:

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

# 5. Intended Use of the Device:

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

| Test Chemotherapy Drug and Concentration | Average BDT |
|-------------------------------------------------|-------------|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

#### 6. Technological Characteristics and Substantial Equivalence:

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

And the properties between the subject device and the predicate device are compared in the following table:

| Characteristics | Standard | Device Performance | | Result of comparison |
|--------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | | Predicate device | Subject Device | |
| Product Code | / | LZA | LZA | Substantial<br>equivalence |
| Characteristics | Standard | Device Performance | | Result of<br>comparison |
| | | Predicate device | Subject Device | |
| Intended Use | / | Predicate device is<br>disposable non-<br>sterile device<br>intended for<br>medical purpose<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner.<br>The average BDT for<br>tested chemotherapy<br>drugs of Fluorouracil,<br>50.0mg/ml<br>(50,000ppm),<br>Etoposide (Toposar),<br>20.0mg/ml<br>(20,000ppm),<br>Cyclophosphamide<br>(Cytoxan), 20mg/ml<br>(20,000ppm),<br>Paclitaxel (Taxol),<br>6.0mg/ml (6,000ppm),<br>Doxorubicin<br>Hydrochloride,<br>2.0mg/ml (2,000ppm),<br>Dacarbazine (DTIC),<br>10.0mg/ml<br>(10,000ppm),<br>Cisplatin, 1.0mg/ml<br>(1,000ppm)<br>is >240min, and<br>Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>less than 30 minutes. | Subject device is<br>disposable non-<br>sterile device<br>intended for<br>medical purpose<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner.<br>The average BDT for<br>tested chemotherapy<br>drugs of Fluorouracil,<br>50.0mg/ml<br>(50,000ppm),<br>Etoposide (Toposar),<br>20.0mg/ml<br>(20,000ppm),<br>Cyclophosphamide<br>(Cytoxan), 20mg/ml<br>(20,000ppm),<br>Paclitaxel (Taxol),<br>6.0mg/ml (6,000ppm),<br>Doxorubicin<br>Hydrochloride,<br>2.0mg/ml (2,000ppm),<br>Dacarbazine (DTIC),<br>10.0mg/ml<br>(10,000ppm),<br>Cisplatin, 1.0mg/ml<br>(1,000ppm)<br>is >240min, and<br>Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>30.9 mins and<br>2.3mins, respectively | Substantial<br>equivalence |
| Characteristics | Standard | Device Performance | | Result of<br>comparison |
| | | Predicate device | Subject Device | |
| Labeling | / | There are no special<br>labeling claims and<br>do not claim gloves<br>as hypoallergenic<br>on labels. | There are no special<br>labeling claims and<br>do not claim gloves<br>as hypoallergenic<br>on labels. | Substantial<br>equivalence |
| Device Materials | / | Nitrile compound | Nitrile Compound | Substantial<br>equivalence |
| Color | / | Blue | Blue | Substantial<br>equivalence |
| Device tolerances and specifications & Performance Data: | | | | |
| Tensile strength:<br>before and after aging | ASTM<br>D6319-10 | Meets | Meets | Substantial<br>equivalence |
| Ultimate elongation:<br>before and after aging | ASTM<br>D6319-10 | Meets | Meets | Substantial<br>equivalence |
| Freedom from<br>pinholes | ASTM<br>D6319-10 | Meets | Meets | Substantial<br>equivalence |
| Dimensions: Overall<br>length, Width, Palm<br>and Finger thickness | ASTM<br>D6319-10 | Meets | Meets | Substantial<br>equivalence |
| Residual powder | ASTM<br>D6319-10,<br>ASTM<br>D6124 | Meets | Meets | Substantial<br>equivalence |
| Biocompatibility | | | | |
| Primary skin irritation<br>test | ISO 10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Substantial<br>equivalence |
| Dermal sensitization<br>assay | ISO 10993-<br>10 | Under conditions of<br>the study, not a<br>sensitizer | Under conditions of<br>the study, not a<br>sensitizer | Substantial<br>equivalence |
| Resistance to Permeation | | | | |
| Resistance to<br>Permeation | ASTM<br>D6978-05 | Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>less than 30<br>minutes. | Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>30.9 minutes and<br>2.3 minutes, | Substantial<br>equivalence |
| Characteristics | Standard | Device Performance | | Result of<br>comparison |
| | | Predicate device | Subject Device | |
| Indication for Use | / | It is disposable non-<br>sterile device<br>intended for<br>medical purpose<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner.<br><br>The average BDT for<br>tested chemotherapy<br>drugs of Fluorouracil,<br>50.0mg/ml<br>(50,000ppm),<br>Etoposide (Toposar),<br>20.0mg/ml<br>(20,000ppm),<br>Cyclophosphamide<br>(Cytoxan), 20mg/ml<br>(20,000ppm),<br>Paclitaxel (Taxol),<br>6.0mg/ml (6,000ppm),<br>Doxorubicin<br>Hydrochloride,<br>2.0mg/ml (2,000ppm),<br>Dacarbazine (DTIC),<br>10.0mg/ml<br>(10,000ppm),<br>Cisplatin, 1.0mg/ml<br>(1,000ppm)<br>is >240min, and<br>Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>less than 30 minutes. | A patient<br>examination glove<br>is disposable non-<br>sterile device<br>intended for<br>medical purpose<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner.<br><br>The average BDT for<br>tested chemotherapy<br>drugs of Fluorouracil,<br>50.0mg/ml<br>(50,000ppm),<br>Etoposide (Toposar),<br>20.0mg/ml<br>(20,000ppm),<br>Cyclophosphamide<br>(Cytoxan), 20mg/ml<br>(20,000ppm),<br>Paclitaxel (Taxol),<br>6.0mg/ml (6,000ppm),<br>Doxorubicin<br>Hydrochloride,<br>2.0mg/ml (2,000ppm),<br>Dacarbazine (DTIC),<br>10.0mg/ml<br>(10,000ppm),<br>Cisplatin, 1.0mg/ml<br>(1,000ppm)<br>is >240min, and<br>Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of<br>30.9 mins and<br>2.3mins, respectively | Substantial<br>equivalence |

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

,

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

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

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

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

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

ર-5

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

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

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D6319-10. biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

| Characteristics | Applicable FDA- Recognized<br>Standards | Performance Results |
|---------------------------------------------------|------------------------------------------------------|------------------------|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from holes | ASTM D 6319-10<br>ASTM D5151-06(2011)<br>21CFR800.20 | Meets |
| Residual Powder Test | ASTM D 6319-10<br>ASTM D6124-06<br>(Reapproved 2011) | Meets |
| Primary Skin Irritation and<br>Skin Sensitization | ISO 10993 Part 10 | Meets |
| Resistance to Permeation | ASTM D6978-05 | See Data in Section 18 |

#### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:

#### 8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.

#### 9. Labeling:

イ

Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) with a chemotherapy claim, which are tested per ASTM D6978, and provide protection against: Fluorouracil, Etoposide (Toposar), Cyclophosphamide (Cytoxan), Paclitaxel (Taxol), Doxorubicin Hydrochloride, Dacarbazine (DTIC), Cisplatin. Do not use with Carmustine and Thiotepa. The tested chemotherapy drugs' breakthrough detection times, refer to item 5 in this summary for details.

We do not claim our gloves as hypoallergenic on our labels.

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

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

#### 10. Conclusions:

Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) conform fully to ASTM D 6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

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

#### July 8, 2014

Better Care Plastic Technology Company, Limited C/O Ms. Kathy Liu Official Correspondent Hongray USA Medical Products, Incorporated 3973 Schaefer Avenue Chino, CA 91710

Re: K140816

Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: June 4, 2014 Received: June 6, 2014

Dear Ms. 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. 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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Page 2 - Ms. Liu

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Maryner -S

Erin I. Keith, M.S. 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

510(k) Number (if known) K140816

#### Device Name

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

#### Indications for Use (Describe)

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

| Test Chemotherapy Drug and Concentration | Average BDT |
|-------------------------------------------------|-------------|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |

Please note that Carmusine and Thiotepa have extremely low permeation times of 2.3 minutes, respectively.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Sreekanth

ly signed by Sreekanth Gutala -S

US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 3.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S 0-2014.07.07 11:46:05 -04'00'

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