POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE

K101630 · Pt. Smartglove Indonesia · LZA · Sep 7, 2010 · General Hospital

Device Facts

• Record ID: K101630
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
• Applicant: Pt. Smartglove Indonesia
• Product Code: LZA · General Hospital
• Decision Date: Sep 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Device Story

Disposable nitrile examination gloves; worn by healthcare examiners to prevent cross-contamination between patient and examiner; provides barrier protection against specific chemotherapy drugs. Device is used in clinical settings; operated by healthcare professionals. Benefits include reduced risk of patient-to-examiner contamination and protection from hazardous chemotherapy agents during handling.

Clinical Evidence

No clinical data. Evidence consists of bench testing for chemotherapy drug permeation, measuring breakthrough detection times for various agents including Carmustine, Thiotepa, and others.

Technological Characteristics

Nitrile material; powder-free; 6mil thickness; blue color; sterile and non-sterile versions; disposable; barrier protection against chemotherapy drugs.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner, and to provide barrier protection against exposure to specific chemotherapy drugs.

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

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Public Health Service

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

Mr. Cho Sow Fong Quality Assurance/ Regulatory Affairs Manager PT. Smart Glove Indonesia JL Raya Medan-Lubuk Pakam KM19, Tanjong Morawa, Deli Serdang Sumatera U Indonesia 20362

SEP 0 7 2010

Re: K101630

Trade/Device Name: Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue) Sterile, Powder Free Nitrile Examination Gloves, Tested For Use

Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 23, 2010 Received: August 26, 2010

Dear Mr. Fong:

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- Mr. Fong

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 CER 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/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,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications for Use

#### 510(k) Number (if known):

Device Name:

1. Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue)

2. Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)

Indication For Use:

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Chemotherapy Drugs Permeation (Average Breakthrough detection time in minutes)

| | Powder Free Nitrile<br>Examination Gloves (6mil) | Sterile, Powder Free Nitrile<br>Examination Gloves |
|-------------------------------------------|--------------------------------------------------|----------------------------------------------------|
| Carmustine (BCNU) (3.3 mg / ml) | 111.9 | 0.51 |
| Thiotepa (10.0 mg / ml) | 162.3 | 36.5 |
| Fluorouracil (50.0 mg / ml) | > 240 | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 | > 240 |
| Mitomycin C (0.5 mg / ml) | > 240 | > 240 |
| Methotrexate (25.0 mg / ml) | > 240 | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 | > 240 |
| Cisplatin (1.0 mg / ml) | > 240 | > 240 |
| Mitoxantrone (2.0 mg / ml) | > 240 | > 240 |
| Ifosfamide (50.0 mg / ml) | > 240 | > 240 |
| Vincristine Sulfate (1.0mg / ml) | > 240 | > 240 |

Please note that the following drugs have extremely low permeation time of less than 30 minutes / 60 minutes (Carmustine and Thiotepa) for Sterile, Powder Free Nitrile Examination Gloves.

AND/OR 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)

Concurrence of CDRH, Office Of Device Evaluation (ODE

Elizabeth F. Claverie-Williams

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101630

## SEP 0 7 2010

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