POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)

K122696 · Cardinal Health, Inc. · LZA · Jan 31, 2013 · General Hospital

Device Facts

• Record ID: K122696
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
• Applicant: Cardinal Health, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jan 31, 2013
• 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.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; ambidextrous design with beaded cuff. Used by healthcare examiners to provide a barrier against contamination between patient and examiner. Device is worn on hands/fingers during clinical examinations. Benefits include protection against cross-contamination. Device is not made with natural rubber latex.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including biocompatibility (ISO 10993-10), physical dimensions, physical properties, freedom from holes (ASTM D5151), and powder residual (ASTM D6124), all meeting ASTM D6319 requirements.

Technological Characteristics

Material: Nitrile. Design: Powder-free, ambidextrous, beaded cuff, non-sterile. Standards: ASTM D6319 (dimensions, physical properties, powder residual), 21 CFR 800.20 (freedom from holes), ISO 10993-10 (biocompatibility).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for over-the-counter use.

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 Cornflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs (K103249)

Submission Summary (Full Text)

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## K122696

JAN 3 1 2013

### 510(K) SUMMARY

## POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)

(A510(k) summary information in accordance with the requirements of 21 CFR 807.92)

| Applicant: | Cardinal Health |
|------------|----------------------|
| | 1430 Waukegan Road |
| | McGaw Park, IL 60085 |

Establishment Registration

| Number: | 1423537 |
|---------|---------|
|---------|---------|

Regulatory Affairs

| Contact: | Tatyana Bogdan, RAC |
|------------|------------------------------------------|
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | [e-mail] |

#### Summary Prepared: October 21, 2012

Trade Name: Powder-Free Nitrile Exam Gloves (Cool Blue) Common Name: Exam Gloves Classification Name: Patient Examination Gloves Classification Panel: General Hospital Regulation: 21 CFR 880.6250 Product Code(s): LZA Legally marketed device(s) to which equivalenceNitrile Comflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs previously cleared under 510(k) K103249 (product code LZA); Reason for 510(k) Submission : New device Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue. 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.

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| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Characteristic | New Device | Predicate Device | | | | | | | | | | | | | | | | | | | | | | |
| Material<br>Composition | Nitrile | Nitrile Cornflower Blue Powder-Free Examination<br>Gloves Tested for Use with Chemotherapy drugs<br>(K103249) | | | | | | | | | | | | | | | | | | | | | | |
| Design | Powder-Free<br>Ambidextrous<br>Beaded Cuff<br>Non-Sterile | Powder-Free<br>Ambidextrous<br>Beaded Cuff<br>Non-Sterile | | | | | | | | | | | | | | | | | | | | | | |
| Color | Cool Blue | Cornflower Blue | | | | | | | | | | | | | | | | | | | | | | |
| Intended Use /<br>Indications for Use | A powder-free<br>patient examination<br>glove is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | A powder-free patient examination glove is a<br>disposable device intended for medical purposes that<br>is worn on the examiner's hand or finger to prevent<br>contamination between patient and examiner.<br><br>In addition, these gloves were tested for use with<br>chemotherapy drugs in accordance with ASTM<br>D6978-05 Standard Practice for Assessment of<br>Medical Gloves to Permeation by Chemotherapy<br>Drugs: | | | | | | | | | | | | | | | | | | | | | | |
| | | Chemotherapy Drug and<br>Concentration Minimum<br>Breakthrough<br>Detection Time<br>in Minutes, 0.01<br>µg/cm²/minute Carmustine (BCNU) (3.3<br>mg/ml) 7.28 Cisplastin, (1.0mg/ml) >240 Cyclophosphamide (20<br>mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Etoposide (Toposar) (20<br>mg/ml) >240 5-Fluorouracil (50 mg/ml) >240 Methotrexate (25 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10 mg/ml) 2.67 The maximum testing time is 240 minutes. Please<br>note that the following drugs have extremely low<br>permeation time of less than 30 minutes: Carmustine<br>(BCNU) (3.3 mg/ml), Thiotepa (10 mg/ml) | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions &<br>Physical Properties | Meets ASTM D6319 | Meets ASTM D6319 | | | | | | | | | | | | | | | | | | | | | | |

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Cardinal Health, Inc. :: . Premarket Notification Submission – Traditional 510(k)

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| Freedom from<br>Holes | AQL meets 21CFR<br>800.20 & ASTM<br>D6319 requirements | AQL meets 21CFR 800.20 & ASTM D6319<br>requirements | |
|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Powder Residual | Meets requirements<br>of ≤2.0 mg/glove for<br>Powder-Free<br>designation per<br>ASTM D6319 | Meets requirements of ≤2.0 mg/glove for Powder-<br>Free designation per ASTM D6319 | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE* | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary | |
| Biocompatibility:<br>Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. | |
| Guinea Pig<br>Maximization | ISO 10993-10 | Gloves do not display any potential for<br>sensitization. | |
| Physical<br>Characteristics:<br>Dimensions | ASTM D6319 | Meet requirements | |
| Physical Properties | ASTM D6319 | Meet requirements | |
| Freedom from Holes<br>(Water Leak test) | 21 CFR 800.20 &<br>ASTM D6319 | Tested in accordance with ASTM D5151 test<br>method with acceptable results | |
| Powder Residual | ASTM D6319 | Tested using ASTM D6124 test method.<br>Gloves meet powder level requirements for<br>"Powder-Free" designation per ASTM<br>D6319. Results generated values < 2mg of<br>residual powder per glove. | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| Biocompatibility:<br>Primary Skin Irritation | ISO 10993-1 | Meets requirements | Meets requirements |
| | ISO 10993-10 | Pass | Pass |
| Guinea Pig<br>Maximization | ISO 10993-10 | Pass | Pass |
| Dimensions | ASTM D6319 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D6319 | Meets requirements | Meets requirements |
| Freedom from Holes<br>(Water Leak Test) | 21CFR800.20,<br>ASTM D6319 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D6319 | Meets requirements | Meets requirements |

Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k)

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### SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical data is not required.

### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The Powder-Free Nitrile Examination Gloves (Cool Blue) meet the technological characteristics of ASTM D6319 performance standard. They are as safe, as effective, and performed as well as the legally marketed device identified in this 510(k) summary except for the chemotherapy permeation claim for which the new device was not tested.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

January 31 2013

Cardinal Health, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062

Re: K122696

Trade/Device Name: Powder-Free Nitrile Exam Gloves (Cool Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 18, 2013 Received: January 22, 2013

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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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,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): KIZZ 696

Device Name:

Powder-Free Nitrile Exam_Gloves (Cool Blue)

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.

Prescription Use (Part 21 CFR 801 Subpart D)

- •

AND/OR

Over-The-Counter Use X (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)

| Ramesh C. Panguluri -S | |
|----------------------------------------------|---------|
| 2013.01.28 11:42:53 -05'00' | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K122696 |

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Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)