POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K083408 · Wrp Asia Pacific Sdn. Bhd. · LZC · Jul 31, 2009 · General Hospital

Device Facts

• Record ID: K083408
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Jul 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested follows [Carmustine (BiCNU), Thip-Tepa. chemotherapy drugs are as Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; ຜ່າ Fluorouracil, Cisplatin, Etoposide and Paclitaxel]. WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.

Device Story

Disposable powder-free blue nitrile patient examination glove; designed to provide barrier protection against patient bodily fluids, waste, and environmental contaminants. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare providers. Provides protection during handling of chemotherapy agents; however, breakthrough time for Carmustine is less than 60 minutes. Not for use with Thio-Tepa.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including physical properties, dimensions, powder content, biocompatibility (skin irritation and sensitization), and chemotherapy drug permeation testing per ASTM D6978-05.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free examination glove. Standards: ASTM D6319-00a (dimensions, physical properties, thickness), ASTM D6124-01 (powder content), ASTM D5151-06 (watertightness), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: Passes primary skin irritation and dermal sensitization (ASTM F-720-81).

Indications for Use

Indicated for use by medical personnel as a disposable barrier glove to prevent cross-contamination between examiner and patient bodily fluids, waste, or environment. Tested for resistance to specific chemotherapy drugs: Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel, and Carmustine. Contraindicated for use with Thio-Tepa.

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

• Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves Non-Sterile (K002064)

Submission Summary (Full Text)

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K08 3408

Appendix E

JUL 3 1 2009

510(K) summary Page 1 of 3

### 510(k) SUMMARY

#### 1.0 Submitter:

| Name: | Mr. Kirk Penner |
|------------|--------------------------------------------------------------|
| Address: | WRP Asia Pacific Sdn Bhd |
| | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, |
| | 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| | |

Date of Summary Prepared: July 2008

### 2.0 Name of the device:

Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs

Common Name: Exam Gloves

Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 product code LZC)

#### 3.0 Identification of The Legally Marketed Devices:

Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves Non-Sterile (Tested For use With Chemotherapy Drug) Labeling Claim Regulatory Class I Product code: LYY 510(k): K002064

#### 4.0 Description of The Device:

Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.

#### 5.0 Intended Use of the Device:

The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested follows [Carmustine (BiCNU), Thip-Tepa. chemotherapy drugs are as Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; ຜ່າ Fluorouracil, Cisplatin, Etoposide and Paclitaxel].

WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA

CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.

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K083408

Appendix E

510(K) summary Page 2 of 3

## 510(k) SUMMARY

### Summary of the Technological Characteristics of the Device: 6.0

The Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM D3578-0151 or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE<br>(Both Predicate and<br>Current) |
|---------------------|---------------------------------------|-------------------------------------------------------|
| Dimensions | ASTM D6319-00a | Meets |
| Physical Properties | ASTM D6319-00a | Meets |
| Thickness | ASTM D6319-00a | Meets |
| Powder Free | ASTM D6124-01 | Meets<br>≤ 2 mg/glove |
| Biocompatability | Primary Skin<br>Irritation | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization<br>ASTM F-720-81 | Passes<br>(Not a contact sensitizer) |
| Watertight (1000ml) | ASTM D5151-06 | Passes |

*Details and discussions of tests can be found in performance section

| CHARACTERISTICS | Predicate Device<br>(K972615) | Current device |
|---------------------------------------------------|------------------------------------------------|------------------------------------|
| Resistance to permeation<br>by Chemotherapy Drugs | Tested to ASTM<br>F739-91<br>Meets requirement | ASTM D6978-05<br>Meets requirement |

All other characteristics including appearance, thickness, material, psychical properties are equivalent to the predicate device. There is essentially no change to the device. This 510(k) submission is to seek approval for the device to be marketed with the ASTM D6978-05 claim on resistance to permeation by chemotherapy drugs.

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K08 3408

Appendix E

510(K) summary Page 3 of 3

## 510(k) SUMMARY

### Substantial Equivalent Based on Assessment of Non-Clinical Performance 7.0 Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

### 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

### 9.0 Conclusion

Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kirk Penner Head of Department, Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi 49300 Sepang Selangor Darul Ehsan MALAYSIA

JUL 3 1 2009

Re: K083408

Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Tested For Use With Chemotherapy Drugs

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I

Product Code: LZC, LZA

Dated: June 25, 2009

Received: July 1, 2009

Dear Mr. Penner:

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.

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 - Mr. Penner

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); fabeling (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Rumer

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix D

### WRP Asia Pacific Sdn Bhd

l of 1 Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepano. Selangor Darul Ehsan MALAYSIA

Office 60-3-8706 1486 [phone] [e-mail] Website www.wipworld.com

# Indications for Use

510(k) Number (if known): K083408

Applicant Name: WRP ASIA PACIFIC SDN BHD

Device Name:

Powder Free Blue Nitrile Patient Examination Gloves, tested for use with Chemotherapy Drugs

Indications for Use:

The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].

### WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.

Prescription Use No (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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