POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL

K083409 · Wrp Asia Pacific Sdn. Bhd. · LZC · Jul 29, 2009 · General Hospital

Device Facts

• Record ID: K083409
• Device Name: POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Jul 29, 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 chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

Device Story

Disposable blue latex examination glove; worn on hand/forefinger by medical personnel. Acts as physical barrier against bodily fluids, waste, and environmental contaminants. Tested for permeation resistance against specific chemotherapy drugs (Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel). Used in clinical settings to protect healthcare providers during chemotherapy drug handling. Provides barrier protection; reduces risk of exposure to hazardous substances. WARNING: Not for use with Thio-Tepa or Carmustine.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM standards for dimensions, physical properties, powder content, protein levels, biocompatibility (skin irritation/sensitization), and watertight integrity.

Technological Characteristics

Blue latex material. Powder-free. Meets ASTM D3578-05 (dimensions, physical properties, thickness), ASTM D6124-06 (powder residue), ASTM D5712-05e1 (protein content <50µg/dm²), ASTM D5151-06 (watertightness), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatible per ASTM F-720-81.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between examiner and patient bodily fluids, waste, or environment. Tested for resistance to specific chemotherapy drugs. Contraindicated for use with Thio-Tepa and Carmustine.

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

• Chemoplus Powder Free Blue latex Examination Gloves (K972615)

Submission Summary (Full Text)

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K083409

Appendix C

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] [phone] Fax No.:

Date of Summary Prepared: July 2008

### 2.0 Name of the device:

Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)

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

510(k) K083409

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

Chemoplus Powder Free Blue latex Examination Gloves with Protein Labeling Claim 50 Micrograms or less. Regulatory Class I Product code: LYY 510(k): K972615

### 4.0 Description of The Device:

Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 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 chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]

WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

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K083409

Appendix C

510(K) summary Page 2 of 3

## 510(k) SUMMARY

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

The Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein) are summarized with the following technological characteristics compared to ASTM D3578-05 or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE<br>(Both Predicate and<br>Current) |
|---------------------|---------------------------------------|-------------------------------------------------------|
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Thickness | ASTM D3578-05 | Meets |
| Powder Free | ASTM D6124-06 | Meets<br>< 2 mg/glove |
| Protein Level | ASTM D5712-05e1 | Meets<br>< 50 $ \mu $ g/g |
| 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 |

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

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

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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KD83409

Appendix C

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.

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

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

### 9.0 Conclusion

Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein) 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three lines representing the wings and legs.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 29 2009

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

Re: K083409

Trade/Device Name: Powder Free Blue Latex Patient Examination Gloves, Tested for Use With Chemotherapy Drugs With a Protein Content Label Claim (<50ug/dm2 Per Glove of Extractable Protein)

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); 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 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.

Antony D. Winter for

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

## WRP Asia Pacific Sdn Bhd

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Safak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSI A

Office 460-3-8706 1486 FacsImile [phone] Email [e-mail] www.wrpworld.com Website

# Indications for Use

510(k) Number (if known): K083409

Applicant Name: WRP ASIA PACIFIC SDN BHD

Device Name:

Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)

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 Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]

## WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

YES

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K083409 |
| Page | of |
| Your Partner In Protection" | |