NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS

K091652 · Hartalega Sdn Bhd · LZA · Sep 4, 2009 · General Hospital

Device Facts

• Record ID: K091652
• Device Name: NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn by medical/dental personnel to prevent cross-contamination during patient examinations. Tested for permeation resistance against specific chemotherapy drugs; breakthrough times provided for 12 agents. Variations (VBLU, ABLU, CBLU) exhibit different breakthrough performance; specific warnings/cautions issued for Carmustine and Thiotepa based on permeation data. Used in clinical/dental settings; provides barrier protection; does not involve electronic processing or software.

Clinical Evidence

Bench testing only. Permeation testing performed for 12 chemotherapy drugs (Carmustine, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Methotrexate, Mitomycin, Paclitaxel, Thiotepa, Vincristine Sulfate) to determine breakthrough times.

Technological Characteristics

Nitrile material; powder-free; disposable; form-fitting glove design. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by medical and dental professionals as a protective barrier on the examiner's hands to prevent cross-contamination between patient and examiner. Not for use with specific chemotherapy drugs as noted in product-specific warnings (e.g., Carmustine, Thiotepa).

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP - 4 2009

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

Ms. Nurul Aisyah Kong Bt Abdullah Quality Assurance Manager Hartalega Sdn. Bhd. No. 7 Kawasan Perusahaan Suria Bestari Java, Selangor 45600 MALAYSIA

Re: K091652

Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - VBLU

Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - ABLU

Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) - CBLU

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I Product Code: LZA, LZC

Dated: August 12, 2009 Received: August 18, 2009

#### Dear Ms. Kong:

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- Ms. Kong

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/CDRH Offices/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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D'areton 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

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### Indication For Use

510(k) Number (if known) : K091652

Device Name :

Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs -VBLU

Indications For Use :

The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The list of chemotheraphy drugs tested (with breakthrough times) are as below:

| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|-------------------------------|-----------------------------|
| 1. Carmustine | 6.60 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 14.83 |
| 12. Vincristine Sulfate | > 240 |

"WARNING: Do not use with Carmustine and Thiotepa."

Prescription Use (Part 21 CFR 801 Subpart D).

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stucke H. M. Humphrey MD

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

510(k) Number: K091452

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# Indication For Use

510(k) Number (if known) : K091652

Device Name :

Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs -ABLU

Indications For Use :

The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:

| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|-------------------------------|-----------------------------|
| 1. Carmustine | 35.80 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 85.48 |
| 12. Vincristine Sulfate | > 240 |

"CAUTION: Testing showed an average breakthrough time of 35.80 minutes with Carmustine."

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela R. Murphy, MD

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

510(k) Number: K091652

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## Indication For Use

510(k) Number (if known) : K091652

Device Name :

Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) -CBLU

Indications For Use :

The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:

| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|-------------------------------|-----------------------------|
| 1. Carmustine | 2.38 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 63.81 |
| 12. Vincristine Sulfate | > 240 |

"WARNING: Do not use with Carmustine."

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 ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

---

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091652

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