Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating

K160411 · Cardinal Health, Inc. · LYZ · Jul 25, 2016 · General Hospital

Device Facts

• Record ID: K160411
• Device Name: Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
• Applicant: Cardinal Health, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Disposable vinyl synthetic polymer examination glove; coated with Neu-Thera® emollient. Ambidextrous design; beaded cuff; non-sterile; powder-free. Used in clinical settings by healthcare professionals to provide a barrier against contamination between examiner and patient. Device functions as a physical barrier; no electronic or mechanical components. Benefits include protection against cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-10: primary skin irritation, guinea pig maximization), physical properties, dimensions, freedom from holes (ASTM D5151), and powder residual levels (ASTM D6124).

Technological Characteristics

Vinyl synthetic polymer; emollient coating. Ambidextrous; beaded cuff. Meets ASTM D5250 (dimensions, physical properties, powder residual) and 21 CFR 800.20 (freedom from holes, AQL 2.5). Non-sterile; single-use. No software or electronic components.

Indications for Use

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

• Cardinal Health's Esteem Stretchy Synthetic with Neu-Thera® Powder-Free Exam Gloves (K052568)

Submission Summary (Full Text)

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

July 25, 2016

Cardinal Health, Inc. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, IL 60085

Re: K160411

Trade/Device Name: Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating (Esteem® Synthetic with Neu-Thera®) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 13, 2016 Received: June 14, 2016

Dear Ms. Middaugh:

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.

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K160411

Device Name

Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu- thera® Coating (Esteem® Synthetic with Neu-Thera®)

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" in black and "Health" in a slightly darker shade of black.

Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com

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## 510(k) SUMMARY

## Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-thera® Coating (Esteem® Synthetic with Neu-Thera®)

| Manufacturer: | Cardinal Health 200, LLC<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Summary Prepared: | July 14, 2016 |
| Product Trade Name: | Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu<br>Thera® Coating (Esteem® Synthetic with Neu-Thera®) |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Classification Panel: | General Hospital and Personal Use Devices |
| Regulation: | 21 CFR 880.6250 |
| Product Code: | LYZ |

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Image /page/4/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The company name, "CardinalHealth," is written in a bold, sans-serif font, with "Cardinal" in regular weight and "Health" in bold.

# 510(K) SUMMARY (CONT'D)

| Predicate Devices: | K052568 - Cardinal Health's Esteem Stretchy Synthetic with Neu-Thera® Powder-Free Exam Gloves |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for 510(k) Submission: | Modification of a legally marketed device |
| Device Description: | The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile. |
| Intended 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. |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. Both gloves are made of synthetic vinyl using the same manufacturing process. |

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# Table 1: Summary of Technological Characteristics

| Summary of the technological characteristics of the device compared to the predicate device | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device | Predicate Device |
| Material<br>Composition | Cardinal Health™ Vinyl Powder-Free<br>Exam Gloves with Neu-Thera® Coating<br>(Esteem® Synthetic with Neu-Thera®) | Cardinal Health's Esteem Stretchy<br>Synthetic with Neu-Thera® Powder-Free Exam Gloves (K052568) |
| Material<br>Composition | Vinyl<br>Coated with emollient coating | Vinyl<br>Coated with emollient coating |
| Design | Ambidextrous<br>Beaded cuff<br>Lubricated | Ambidextrous<br>Beaded cuff<br>Lubricated |
| Intended Use | A patient examination glove is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand or finger to prevent contamination<br>between patient and examiner. | A patient examination glove is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand or finger to prevent contamination<br>between patient and examiner. |
| Label Claims | Single Use Only<br>Non-sterile<br>Powder-free<br>Not made with natural rubber latex<br>Coated with proprietary formulation | Single Use Only<br>Non-sterile<br>Powder-free<br>Not made with natural rubber latex<br>Coated with proprietary formulation |
| Dimensions &<br>Physical<br>Properties | Meets ASTM D5250 | Meets ASTM D5250 |
| Freedom from<br>Holes | Meets 21CFR 800.20 & ASTM D5250<br>requirements of AQL 2.5 | Meets 21CFR 800.20 & ASTM D5250<br>requirements of AQL 2.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for<br>Powder-Free designation per ASTM<br>D5250 | Meets requirements of ≤2.0 mg/glove<br>for Powder-Free designation per ASTM<br>D5250 |

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# Table 2: Summary of Non-Clinical Tests

| PERFORMANCE DATA | | |
|-------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION | | |
| OF SUBSTANTIAL EQUIVALENCE<br>Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary |
| Biocompatibility: | | |
| Primary Skin<br>Irritation | ISO 10993-10 | Non-irritating |
| Guinea Pig<br>Maximization | ISO 10993-10 | Non-sensitizing |
| Physical Characteristics: | | |
| Dimensions | ASTM D5250 | Meets requirements |
| Physical Properties | ASTM D5250 | Meet requirements for vinyl examination<br>gloves |
| Freedom from Holes | 21 CFR 800.20 &<br>ASTM D5250 | Tested in accordance with ASTM D 5151<br>with acceptable results; Meets<br>requirements of AQL 2.5 |
| Powder Residual | ASTM D5250 tested<br>using ASTM<br>standard D6124 | Gloves meet powder level requirements for<br>"Powder-Free" designation per ASTM<br>D5250. Results generated values < 2mg of<br>residual powder per glove. |

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## Table 3: Summary of Comparative Performance

| Comparative Performance Information Summary | | | |
|---------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Characteristic | Requirement | Subject Device | Predicate Device |
| Biocompatibility: | ISO 10993-1 | Cardinal Health™ Vinyl<br>Powder-Free Exam Gloves with<br>Neu-Thera® Coating (Esteem®<br>Synthetic with Neu-Thera®) | Cardinal Health's Esteem<br>Stretchy Synthetic with Neu-<br>Thera® Powder-Free Exam<br>Gloves (K052568) |
| Primary Skin Irritation | ISO 10993-10 | Non-irritating | Non-irritating |
| Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing | Non-sensitizing |
| Dimensions | ASTM D5250 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D5250 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20,<br>ASTM D5250 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D5250 | Meets requirements | Meets requirements |

## 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 DATA

Non-clinical data demonstrates Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating (Esteem® Synthetic with Neu-Thera®) meet the technological characteristics of ASTM D5250 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.