STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING

K111015 · Cardinal Health, Inc. · KGO · May 6, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111015
• Device Name: STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, powder-free surgeon's glove; manufactured from natural rubber latex; features hydrogel polymer coating, anti-slip finish, independent thumb, and mechanically locking cuffs to prevent roll down. Used by operating room personnel to protect surgical wounds from contamination. Device provides physical barrier; performance verified against ASTM D3577 standards for dimensions, physical properties, and freedom from holes. Protein content limited to 50 µg/dm² or less per ASTM D5712. Non-irritating and non-sensitizing per biocompatibility testing.

Clinical Evidence

No clinical data required. Bench testing performed: Primary skin irritation (non-irritating), Guinea pig maximization (no sensitization), dimensions and physical characteristics (ASTM D3577), freedom from holes (21 CFR 800.20/ASTM D3577), powder residual (ASTM D6124, <2mg/glove), and protein content (ASTM D5712, <50 µg/dm²).

Technological Characteristics

Material: Natural rubber latex. Coating: Hydrogel polymer. Design: Anti-slip finish, independent thumb, mechanically locking cuffs. Standards: ASTM D3577 (dimensions, physical properties, freedom from holes), ASTM D6124 (powder residual), ASTM D5712 (protein content). Sterilization: Sterile.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Disposable device made of natural rubber latex.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating (K101811)

Submission Summary (Full Text)

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K111015

MAY - 6 2011

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH HYDROGEL COATING

| Applicant: | Cardinal Health, Inc. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1430 Waukegan Road<br>McGaw Park, IL 60085 |
| Telephone: | 847-887-2325 |
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
| Date Summary Prepared: | February 18, 2011 |
| Product Trade Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating<br>with Protein Content Label Claim of 50 $\mu$ g/dm2 or less |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Device Description: | The proposed device is a sterile latex powder-free surgical glove<br>that is formulated using natural rubber latex. The glove is coated<br>with hydrogel polymer coating.<br><br>The glove is manufactured using molds that feature anti-slip finish,<br>independent thumb and mechanically locking cuffs to help prevent<br>cuff roll down. They are offered powder-free and sterile. |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable device made<br>of natural rubber intended to be worn by operating room personnel<br>to protect a surgical wound from contamination. |
| Predicate Devices: | Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating<br>with Protein Content Label Claim of 50 $\mu$ g/dm2 or less previously<br>cleared under 510(k) K101811 (product code KGO). |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate<br>device identified in this 510(k) summary. Substantial equivalence<br>can be established in regard to intended use, physical properties<br>and characteristics, design and product features. Both gloves are<br>made of natural rubber latex using similar manufacturing process. |
| Performance Testing: | The glove characteristics are summarized below as compared to<br>ASTM requirements and to the predicate device. |
| Test: | Result: |
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTM<br>D3577. |
| Freedom From Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free"<br>designation per ASTM D3577 tested using ASTM standard<br>D6124. Results generated values below 2mg of residual powder<br>per glove. |
| Protein Content | Gloves have been tested in accordance with ASTM D5712 and<br>yielded the results of less than 50 µg/dm² of total water extractable<br>protein per glove |
| Clinical Data: | No clinical data is required. |
| Conclusion: | The Sterile Latex Powder-Free Surgical Gloves with Hydrogel<br>Coating with Protein Content Label Claim of 50µg/dm² or less<br>meet the technological characteristics of ASTM D3577 Standard<br>Specification for Rubber Surgical Gloves and are substantially<br>equivalent to the predicate device identified in this 510(k)<br>summary. |

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

K111015

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (CONT'D)

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

MAY - 6 2011

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K111015

Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating with Protein Content Label Claim of 50 µg/dm- or Less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: April 21, 2011 Received: April 22, 2011

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 liederal 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/ucm 115809.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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

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): K 015 |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating with<br>Protein Content Label Claim of 50 µg/dm+ or less |
| | Indications for Use: A powder-free sterile surgeon's glove is a disposable device made of<br>natural rubber intended to be worn by operating room personnel to protect<br>a surgical wound from contamination. |

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: _ K | | | O | 5

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