DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

K043508 · Ansell Healthcare Products, LLC · KGO · Jan 19, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043508
• Device Name: DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
• Applicant: Ansell Healthcare Products, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.

Device Story

Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves are sterile, disposable synthetic rubber gloves. Used by operating room personnel to provide a barrier against contamination of surgical wounds and to provide protection during the handling of chemotherapy drugs. The device functions as a physical barrier; it is worn on the hands of clinicians. No electronic, mechanical, or software components are involved in the device function.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing per ASTM D 3577, freedom from holes per ASTM D 5151, powder content per ASTM D 6124, and biocompatibility testing (primary skin irritation, guinea pig sensitization, and cytotoxicity).

Technological Characteristics

Material: Polychloroprene synthetic rubber. Dimensions, physical properties, and freedom from holes meet ASTM D 3577. Powder-free (≤ 2 mg per glove) per ASTM D 6124. Biocompatibility: Passes primary skin irritation, guinea pig sensitization, and cytotoxicity (end-point titration method). Sterile, disposable.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination and for handling chemotherapy drugs.

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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**Ansell**

K043508

- 510(k) SUMMARY [ 1 ] Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use)
- [2] Ansell Healthcare Products LI.C. 1635 Industrial Road Dothan, AL 36303

Contact: Lon D. Mcllvain. Vice President Regulatory Affairs [phone] Telephone: [phone] Fax:

December 17, 2004

| [3] Trade Name: | Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) |
|----------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Glove |

- 141 Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 3577, Type 2.
- Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves ાં રા (Chemotherapy Use) meet all of the current specifications of ASTM D 3577, Type 2.
- Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves [6] (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
- [7] Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 |
| Freedom from Holes | Meets ASTM D 3577<br>Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124<br>Powder content ≤ 2 mg per glove |
| Biocompatibility<br>Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization<br>Cytotoxicity Study using<br>the End-Point Titration Method | Passes<br>Passes<br>Non-Toxic at 24 hours |

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- The performance test data of the non-clinical tests are the same as mentioned [8] immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the ાં તે તે 510(k) process.
- It is concluded that Derma Prene® Ultra Powder-Free Polychloroprene Synthetic [10] Surgical Gloves (Chemotherapy Use) 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 ||||| FDA.

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JAN 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lon D. Mcllvain Vice President Regulatory Affairs Ansell Healthcare Products LLC 1635 Industrial Road Dothan, Alabama 36303

Re: K043508

Ro43306
Trade/Device Name: Derma Prene® Ultra Powder-Free Green Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 17, 2004 Received: December 20, 2004

Dear Mr. Mcilvain:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rowed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of / Including, or to ac read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls promots or a 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 (1 MI), it may a subject of Federal Regulations, Title 21, Parts 800 to 898. In your device earner publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mcilvain

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that 1 DT is issualites or that your device complies with other requirements Incall that I DA has made a decembers and regulations administered by other Federal agencies. of the Act of ally I edelar states and squirements, including, but not limited to: registration You must comply with an the Piece See Books (21 CFR Part 801); good manufacturing practice and listing (21 CF R Furt 607), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (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) I mis letter will anow yourse begin finding of substantial equivalence of your device to a premits in the month - The PDF missis 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), If you desire specific at not to: Journer 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 may obtain 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,

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 Statement

| 510(k) Number (if known) | K043508 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Derma Prene® Ultra Powder-Free Green Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) |
| Indications for Use | A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs. |

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Sutte M. Ohaio O m.D.

-

(Division Sign Off) Oivision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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KO43508 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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