BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM

K121926 · Northstar Healthcare Holdings · LZC · Sep 20, 2012 · General Hospital

Device Facts

• Record ID: K121926
• Device Name: BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
• Applicant: Northstar Healthcare Holdings
• Product Code: LZC · General Hospital
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:

Device Story

Disposable latex examination glove; textured surface; blue color. Designed for use by medical/dental professionals to provide barrier protection against contaminants. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides protection during handling of hazardous drugs; breakthrough times vary by agent (e.g., Carmustine and Thiotepa show low breakthrough times). Used in clinical/medical settings. Benefits include reduced risk of cross-contamination and protection from chemical exposure during chemotherapy administration.

Clinical Evidence

Bench testing only. Compliance demonstrated with ASTM D3578-05 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual), ASTM D5712-10 (protein levels), and ISO 10993-1/10 (biocompatibility, skin irritation, sensitization). Chemotherapy drug permeation tested per ASTM D6978-05.

Technological Characteristics

Material: Latex. Form factor: Textured, blue, powder-free examination glove. Standards: ASTM D3578-05 (physical/dimensions), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder), ASTM D5712-10 (protein <50mcg/mg), ISO 10993-1/10 (biocompatibility).

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical personnel to prevent cross-contamination between patient and examiner. 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.

Predicate Devices

• Latex Powder Free Examination Gloves (Blue) Tested For Use With Chemotherapy Drugs (K083409)

Submission Summary (Full Text)

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Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves

510(k) SUMMARY

5.

Section 5, 510(k) Summary Page 1 of 3

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K121926/.

| DATE: | February 17, 2010 | | SEP 2 0 2012 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| OWNER: | McKesson Medical Surgical International<br>70 Sir John Rogerson's Quay<br>Dublin 2, Ireland | | |
| OFFICIAL CORRESPONDENT: | Anthony L. Giaccio<br>Manager, Quality Systems and Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| DEVICE NAME: | Trade Name: | Textured, Blue, Latex Powder Free Examination<br>Gloves, Tested For Use With Chemotherapy<br>Drugs With Protein Labeling Claim (50μg/dm2<br>Or Less Of Water Soluble Protein) | |
| | Common Name: | Patient Examination Gloves | |
| | Classification: | Patient Examination Gloves | |
| | Class: | Class I | |
| | Product Code: | LZC | |

# PREDICATE DEVICE(S):

| Predicate<br>510(k) | Device Name | Indication | Clearance<br>Date | Company |
|---------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------|
| K083409 | Latex Powder Free<br>Examination Gloves<br>(Blue) Tested For<br>Use With<br>Chemotherapy Drugs | The latex examination glove (Tested for<br>Use with Chemotherapy Drugs) is a<br>disposable device intended for medical<br>and dental purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | 29 Jul 2009 | WRP ASIA<br>PACIFIC SDN,<br>BHD |

DEVICE DESCRIPTION: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).

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# STATEMENT OF INTENDED USE:

The 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.

i

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:

### Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)

| Chemotherapy Drug | Average Breakthrough<br>Detection Time (Min) |
|-------------------------------------------|----------------------------------------------|
| Carmustine (BCNU) (3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | No breakthrough up to 240 min |
| Cyclophosphamide (Cytoxan)<br>(20.0 g/mL) | No breakthrough up to 240 min |
| Dacarbazine (DTIC) (10.0<br>mg/mL) | No breakthrough up to 240 min |
| Doxorubicin Hydrochloride (2.0<br>mg/mL) | No breakthrough up to 240 min |
| Etoposide (20.0 mg/mL) | No breakthrough up to 240 min |
| Fluorouracil (Adrucil) (50.0<br>mg/mL) | No breakthrough up to 240 min |
| Methotrexate (25.0 mg/mL) | No breakthrough up to 240 min |
| Mitomycin C (0.5mg/mL) | No breakthrough up to 240 min |
| Paclitaxel (Taxol) (6.0mg/mL) | No breakthrough up to 240 min |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | No breakthrough up to 240 min |

The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine and Thiotepa, have extremely low permeation time of less than 30 minutes.

The Latex Powder Free Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.

## TECHNOLOGICAL CHARACTERISTICS:

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Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves

Section 5, 510(k) Summary Page 3 of 3

:

## ASSESSMENT OF NONCLINICAL DATA:

| Characteristic | Standard | Device<br>Performance |
|--------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom from<br>Pinholes | 21 CFR 800.20; ASTM D5151-<br>06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | Meets<br>Results generated<br>values below 2mg of<br>residual powder |
| Protein Level | ASTM Standard D5712-10 | Meets<br>Results generated<br>values below 50<br>mcg/mg of protein |
| Biocompatibility | Biological Evaluation of Medical<br>Devices part 1: Evaluation and<br>Testing (ISO 10993-1:2009) | Meets |
| | Primary Skin Irritation in rabbits<br>(ISO 10993-10:2010) | Gloves are non-<br>irritating |
| | Dermal Sensitization in the<br>guinea pig (ISO 10993-10:2010) | Gloves do not display<br>any potential for<br>sensitization |

### CONCLUSIONS:

The Latex Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 ISO 10993-1:2009 and ISO 10993-10:2010.

Based on the comparison of intended use, design, materials and performance, the Latex Powder Free Examination Gloves Tested for Use With Chemotherapy Drugs are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

SEP 20 2012

Northstar Healthcare Holdings C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories. Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K121926

Trade/Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50 ug/dm2 Or Less Of Water Soluble Protein)

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Gloves

Regulatory Class: Class I

Product Code: LZC

Dated: September 4, 2012

Received: September 5, 2012

Dear Mr. Devine:

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. Devine

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/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,

For Scott Robertson

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): K121926

#### Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50ug/dm2 Or Less Of Water Soluble Protein).

Indications for Use: The 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in<br>Minutes |
|-----------------------------------------|---------------------------------------------------|
| Carmustine (BCNU)(3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL) | >240 |
| Dacarbazine (DTIC) (10.0 mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/mL) | >240 |
| Etoposide (20.0 mg/mL) | >240 |
| Fluorouracil (Adrucil) (50.0 mg/mL) | >240 |
| Methotrexate (25 mg/mL) | >240 |
| Mitomycin C (0.5mg/mL) | >240 |
| Paclitaxel (taxol) (6.0 mg/mL) | >240 |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | >240 |

The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine (BCNU) and Thiotepa have extremely low permeation time of less than 30 minutes.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (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)

ion of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number;

K121926