DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

K071746 · Ansell Healthcare Products, LLC · KGO · Dec 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071746
• Device Name: DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
• Applicant: Ansell Healthcare Products, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Derma Prene® PI or Isotouch® Green are sterile, powder-free, synthetic polyisoprene surgical gloves. Used by operating room personnel to provide a protective barrier between the wearer and the surgical site, preventing wound contamination. Devices are disposable and intended for single use. Performance is verified through adherence to ASTM standards for physical properties, dimensions, and freedom from holes.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including physical property testing per ASTM D 3577-06, freedom from holes per ASTM D 5151, powder content per ASTM D 6124, and biocompatibility studies (ISO Maximization Sensitization, FHSA Skin Irritation, and Cytotoxicity).

Technological Characteristics

Material: Synthetic polyisoprene. Powder-free (ASTM D 6124). Dimensions and physical properties meet ASTM D 3577-06, Type 2. Freedom from holes meets ASTM D 5151. Sterile, disposable form factor.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population, age, or gender restrictions defined.

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.

Submission Summary (Full Text)

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K071746

**Ansell**

## [1] 510(k) SUMMARY

- [2] Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
## DEC 1 3 2007

| Contact: | Lon D. McIlvain<br>Vice President, Regulatory and Quality Affairs, Global |
|------------|---------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

June 25, 2007

- Derma Prene® PI or Isotouch® Green Sterile Powder-Free . [3] Trade Name: Synthetic Polyisoprene Surgical Gloves
Common Name: Surgical Gloves

Classification Name: Surgeon's Gloves, powder-free (21 CFR §878.4461 proposed)

- [4] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the requirements of ASTM D 3577-06, Type 2.
- [5] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the current specifications of ASTM D 3577-06, Type 2.
- Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene [6] Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|-----------------------------------|------------------------------------------------|
| Dimensions<br>Physical Properties | Meets ASTM D 3577<br>Meets ASTM D 3577, Type 2 |
| Freedom from Holes | Meets ASTM D 3577<br>Meets ASTM D 5151 |
| Powder Free | Meets ASTM D 6124 |

IS AS I M D 0 Powder content = 2 mg per glove

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Biocompatibility:

[8]

FHSA Skin Irritation Study ISO Maximization Sensitization Study Cytotoxicity Study using the End-Point Titration Method

Passes Passes

Non-Toxic at 24 hours

The performance test data of the non-clinical tests are the same as mentioned immediately above.

- Clinical data is not needed for medical gloves or for most devices cleared by the [9] 510(k) process.
It is concluded that Derma Prene® PI or Isotouch® Green Sterile Powder-Free (10) Synthetic Polyisoprene Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

> ASTM listed standards, FDA hole requirements, and labeling claims for the product.

- This summary will include any other information reasonably deemed necessary by the [1] FDA.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ansell Healthcare Products, LLC Ms. Cynthia A. Ingram Regulatory Affairs Manager, Americas 1635 Industrial Road Dothan, Alabama 36303

Re: K071746

Trade/Device Name: Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 29, 2007 Received: November 30, 2007

Dear Ms. Ingram:

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. Ingram

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 [phone]. 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/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

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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## INDICATIONS FOR USE

## 510(K) Number (if known):

Device Name:

Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves

Indications For Use:

These gloves are intended to be worn by operating room personnel to protect 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 IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Stele H. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

-10-