BLUE POWDERFREE NITRILE EXAMINATION GLOVE

K102623 · Pt. Medisafe Technologies · LZA · Jun 6, 2011 · General Hospital

Device Facts

• Record ID: K102623
• Device Name: BLUE POWDERFREE NITRILE EXAMINATION GLOVE
• Applicant: Pt. Medisafe Technologies
• Product Code: LZA · General Hospital
• Decision Date: Jun 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.

Device Story

Powder-free blue nitrile examination gloves; disposable; worn on hands/fingers by healthcare personnel. Primary function: barrier protection to prevent cross-contamination between examiner and patient. Tested for permeation resistance against specific chemotherapy drugs (Carmustine, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Flourouracil, Paclitaxel, Thiotepa). Used in clinical settings; provides protection during handling of hazardous chemotherapy agents. Benefits include reduced risk of exposure to patient pathogens and chemotherapy chemicals.

Clinical Evidence

Bench testing only. Permeation testing performed for chemotherapy drugs; breakthrough detection times reported for nine specific agents.

Technological Characteristics

Material: Nitrile rubber. Form factor: Powder-free examination glove. Color: Blue. Barrier protection: Tested for chemotherapy drug permeation resistance.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between examiner and patient. Tested for use with 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Anil Taneja Chief Executive Officer PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia 20362

JUN - 6 2011

Re: K102623

Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: May 16, 2011 Received: May 23, 2011

Dear Mr. Taneje:

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. Taneja

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/ucm 115809.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/Safetv/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,

Cintmony D. Water

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

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## ATTACHMENT B

## Indications for Use

Applicant : Medisafe Technologies

510(k) Number (if known): Not Known

Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.

Indications For Use:

Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.

| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.<br>The following chemicals have been tested with these gloves | | |
|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------|
| 1 | Carmustine | 1.04 |
| 2 | Cisplatin | >240 |
| 3 | Cyclophosphamide | >240 |
| 4 | Dacarbazine | >240 |
| 5 | Doxorubicin Hydrochloride | >240 |
| 6 | Etoposide | >240 |
| 7 | Flourouracil | >240 |
| 8 | Paclitaxel | >240 |
| 9 | Thiotepa | = 165 |
| | | |

## Please note that Carmustine has an extremely low permeation time of less than 30 minutes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth T. Clarence-Williams

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

510(k) Number: K102623