ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

K031301 · Cardinalhealth · KGO · Oct 15, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031301
• Device Name: ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
• Applicant: Cardinalhealth
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Esteem Sterile Polyisoprene Surgical Gloves with Coating are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, powder-free surgical gloves formulated from synthetic rubber latex. Used by operating room personnel in hospitals and healthcare facilities during invasive and non-invasive medical procedures. Primary function is to provide a sterile barrier to protect surgical wounds from contamination. Device is a passive physical barrier; no electronic or mechanical components.

Clinical Evidence

Bench testing only. Testing included primary skin irritation (non-irritating), guinea pig maximization (no sensitization), ultimate elongation and tensile strength (exceeds ASTM D3577-01), barrier defects (exceeds 21 CFR §800.20 and ASTM D3577-01, AQL = 1.5), and residual powder levels (below 2 mg/glove per ASTM D6124-00).

Technological Characteristics

Synthetic rubber latex material. Powder-free design. Sterile. Dimensions and physical properties meet ASTM D3577-01 standards. Barrier integrity meets 21 CFR §800.20 requirements. Residual powder levels verified per ASTM D6124-00.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination during invasive and non-invasive medical procedures requiring sterility in hospital and healthcare facility environments.

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

• Esteem Sterile Polyisoprene Surgical Gloves

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of the words "CardinalHealth" in a simple, sans-serif font. Above the text, there is a graphic element that appears to be a stylized representation of a bird in flight or a series of abstract lines.

## OCT 1 5 2003

## XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

K031301

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING '

| Regulatory Affairs Contact: | Erica Sethi<br>Cardinal Health<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Date Summary Prepared: | 4/7/03 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Esteem Sterile Polyisoprene Surgical Gloves |
| Description: | Esteem Sterile Polyisoprene Surgical Gloves with Coating are<br>formulated using Synthetic Rubber Latex. These are offered<br>powder-free and sterile. |
| Intended Use: | Esteem Sterile Polyisoprene Surgical Gloves with Coating are<br>intended for use in environments within hospitals and other<br>healthcare facilities. The gloves are appropriate for use during<br>invasive and non-invasive medical procedures requiring<br>sterility. They are intended to be worn by operating room<br>personnel to protect a surgical wound from contamination. |

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# K031301

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| Substantial Equivalence: | Esteem Sterile Polyisoprene Surgical Gloves with Coating are<br>substantially equivalent to Esteem Sterile Polyisoprene Surgical<br>Gloves in that they provide the following characteristics:<br>- same intended use<br>- same sizes, product features, packaging<br>- both made of Synthetic Rubber Latex using similar manufacturing<br>process |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | |
| Test | Result |
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Ultimate Elongation<br>& Tensile Strength | Gloves exceed requirements for rubber surgical gloves<br>per ASTM D3577-01. |
| Barrier Defects | Gloves exceed requirements per 21 CFR<br>§800.20 and ASTM D3577-01, AQL = 1.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free"<br>designation using ASTM Standard D6124-00-Standard test method<br>for residual powder on medical gloves. Results generated values<br>below 2 mg of residual powder per glove. |

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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Ms. Erica Sethi Manager, Regulatory Affairs Cardinal Heath Medical Product and Services 1500 Waukegan Road Building WM Mcgaw Park, Illinois 60085

Re: K031301

Trade/Device Name: Esteem Sterile Polyisoprene Powder Free Surgical Gloves with Coating Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 23, 2003 Received: July 24, 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 (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.

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 vour 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.

Clis

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 a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.

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

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| Applicant: | Cardinal Health |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | KO31301 |
| Device Name: | Esteem Sterile Polyisoprene Powder Free Surgical Gloves With Coating* |
| Indications For Use: | These gloves are intended to be worn by operating room personnel to<br>protect a surgical wound from contamination in environments within<br>hospitals and other healthcare facilities. The gloves are appropriate<br>for use during invasive as well as non-invasive medical procedures<br>requiring sterility. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Or

Over-The Counter Use

Patricia D. Anderson Branch Chief, 10/15/03

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

510(k) Number: KD31301