NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY

K032444 · Cardinalhealth · LZC · Nov 13, 2003 · General Hospital

Device Facts

• Record ID: K032444
• Device Name: NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
• Applicant: Cardinalhealth
• Product Code: LZC · General Hospital
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Device Story

Disposable nitrile examination glove with lotion coating; worn on hands/fingers by healthcare providers. Prevents cross-contamination between patient and examiner; provides barrier protection against chemotherapy drugs. Device is non-sterile, powder-free, and beaded. Used in clinical settings for standard examination and chemotherapy handling. Benefits include barrier protection for the wearer and patient.

Clinical Evidence

Bench testing only. Primary skin irritation and guinea pig maximization tests showed no irritation or sensitization potential. Tensile strength met ASTM D6319-00a3. Barrier defects met 21 CFR 800.20 and ASTM D6319-00a3. Chemotherapy drug resistance tested per ASTM F739-99a.

Technological Characteristics

Material: Nitrile with lotion coating. Form: Beaded, powder-free. Standards: ASTM D6319-00a3 (tensile strength/barrier), ASTM F739-99a (chemotherapy drug permeation), 21 CFR 800.20 (barrier).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner, and to protect the wearer against exposure to 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 Powder-Free Examination Gloves, Cardinal Health

Submission Summary (Full Text)

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K032444

NOV 1 3 2003

Image /page/0/Picture/2 description: The image shows the Cardinal Health logo. The logo consists of the words "CardinalHealth" in a stylized font. Above the text, there is a graphic element that resembles a series of intersecting lines or strokes, possibly representing a stylized bird or abstract design.

## XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LOT OF STOP TH COATING, BLUE NITRILE POWDER-FREE EXAMINA TION GLC WIFF for

Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact: Erica Sethi Cardinal Health 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone: [phone]

Date Summary Prepared: 7/25/03

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Nitrile Powder-Free Examination Gloves, Cardinal Health,

Description: Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

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K032444

Page 2

Substantial Equivalence: Nitrile Powder-Free Examination Gloves with Coating are substantially equivalent to Cardinal Health's Nitrile Powder-Free Examination Gloves in that they provide the following characteristics:

- same intended use
- same sizes
- both made of nitrile
- both offered beaded and powder-free
- both worn to protect the wearer against exposure to chemotherapy drugs

## Summary of Testing:

| Test | Result |
|-------------------------|-------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D6319-00a3. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20<br>and ASTM D6319-00a63. |
| Chemotherapy testing | Tested for chemotherapy drugs using ASTM F739-99a |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

NOV 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health C/O Ms. Erica Sethi Manager, Regulatory Affairs Medial Product and Services 1500 Waukegan Road Bldg WM Mcgaw Park, Illinois 60085

Re: K032444

Trade/Device Name: Nitrile Powdered- Free Examination Glove with Lotion Coating And use for Chemotherapy Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: October 23, 2003 Received: October 30, 2003

Dear Ms. Sethi:

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 such 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. Sethi

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594- 4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

QurLs

Chiu Lin, Ph.D. 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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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a sans-serif font, with the word "Cardinal" in a smaller font size than the word "Health."

1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

Susanna F. Basuld

Anesthesiology, General Hospital, on Control, Dental Devices

510(k) Number: K032444

Page 1 of 1

Applicant:

Cardinal Health

<032444

510(k) Number:

Device Name: Undetermined

Indications For Use: A 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 are worn to protect the wearer against exposure to chemotherapy drugs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-The Counter Use