NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM

K103249 · Cardinal Health, Inc. · LZA · Dec 16, 2010 · General Hospital

Device Facts

• Record ID: K103249
• Device Name: NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
• Applicant: Cardinal Health, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A powder-free 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. 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 by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; cornflower blue color. Designed for use by healthcare professionals to provide a protective barrier against contaminants. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; worn on hands/fingers. Provides barrier protection; reduces risk of cross-contamination during patient examinations and handling of chemotherapy agents.

Clinical Evidence

No clinical data is required. Bench testing only: primary skin irritation and guinea pig maximization tests confirm non-irritating and non-sensitizing properties. Permeation testing performed per ASTM D6978-05 for nine chemotherapy drugs.

Technological Characteristics

Material: Nitrile. Form: Powder-free, non-sterile, cornflower blue. Standards: ASTM D6319 (physical dimensions, physical properties, freedom from holes), ASTM D6124 (residual powder), ASTM D6978-05 (chemotherapy permeation).

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical personnel 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.

Predicate Devices

• Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim (K022765)

Submission Summary (Full Text)

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K103249

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of three curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.

DEC 16 2010

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### NITRILE POWDER-FREE EXAMINATION GLOVES

YTY Industry (Manjung) Sdn. Bhd. Manufacturer: Lot 1422 - 1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia

Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085

847-887-2325 Telephone:

- October 11, 2010 Date Summary Prepared:
Stretchy Nitrile Cornflower Blue Powder-Free Exam Gloves with Product Trade Name: Tested for Use with Chemotherapy Drug Labeling Claim

- Exam Gloves Common Name:
- Classification Name: Patient Examination Gloves
- Device Description: These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and nonsterile. Gloves are comflower blue in color. Gloves are not made with natural rubber latex.

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## Intended Use:

A powder-free 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.

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 by Chemotherapy Drugs:

| | Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection Time<br>in Minutes, 0.01 µg/cm2/minute |
|----|----------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 7.28 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCI (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 2.67 |

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

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

# Predicate Devices:

Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim previously cleared under 510(k) K022765 (product code LZA);

#### Substantial Equivalence:

These Nitrile powder-free examination gloves are substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical characteristics, design and product features. Both gloves are made with Nitrile using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.

#### Performance Testing:

| <b>Test:</b> | <b>Result:</b> |
|-------------------------|--------------------------------------------------------|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |

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| Dimensions | Gloves meet requirements of ASTM D6319. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Characteristics<br>ASTM | Gloves meet requirements for Nitrile examination gloves per<br>D6319. |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D6319 |
| Powder Residual | Gloves meet powder level requirements for “Powder-Free”<br>designation per ASTM D6319 tested using ASTM standard<br>D6124, Standard test method for residual powder on medical<br>gloves. Results generated values below 2mg of residual powder<br>per glove. |
| Chemotherapy Permeation | Gloves were tested using ASTM D6978, Standard Practice for<br>Assessment of Resistance of Medical Gloves to Permeation by<br>Chemotherapy Drugs. The maximum testing time is 240 minutes. |
| Clinical Data: | |

No clinical data is required.

# Conclusion:

The Stretchy Nitrile Powder-Free Exam Gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.

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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 features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

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Cardinal Health, Incorporated C/O Ms. Tatyana Bogdan Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

DEC 16 2010

Re: K103249

Trade/Device Name: Nitrile Comflower Blue Powder-Free Exam Gloves tested for use with Chemotherapy Drugs Labeling Claim . Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2010 Received: December 13, 2010

Dear Ms. Bogdan:

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- Ms. Bogdan

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jams Jizdado
for

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

2

Radiological Health

Enclosure ·

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050 16 2013

# Indications for Use

510(k) Number (if known): K1032 49

Nitrile Comflower Blue Powder-Free Exam Gloves WiTH TESTED for Device Name: USE with Chemotherary Drugs Labeling Claim

Indications for Use: A powder-free 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.

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 by Chemotherapy Drugs:

| | Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection Time<br>in Minutes, 0.01 µg/cm²/minute |
|----|----------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 7.28 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 2.67 |

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

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Elight D-Clawro Well

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
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(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

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| 510(k) Number: | K103249 |

Cardinal Health, Inc.

Premarket Notification Submission - Traditional 510(k)

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