ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

K984559 · Ansell Perry · KGO · Feb 26, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984559
• Device Name: ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 26, 1999
• 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

Sterile, disposable, powder-free polyurethane synthetic surgical gloves; intended for use by operating room personnel. Protects surgical wounds from contamination; provides barrier protection during handling of chemotherapy drugs. Device functions as physical barrier; performance verified against ASTM D 3577 (Type 2) standards for dimensions and physical properties. Biocompatibility confirmed via primary skin irritation and guinea pig sensitization testing. Powder-free status verified via ASTM D 6124 (residue mass). Freedom from holes verified via ASTM D 5151.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D 3577 (dimensions, physical properties), ASTM D 5151 (freedom from holes), and ASTM D 6124 (powder residue). Biocompatibility confirmed via primary skin irritation and guinea pig sensitization studies.

Technological Characteristics

Material: Polyurethane synthetic rubber. Form factor: Sterile, disposable surgical glove. Standards: ASTM D 3577 (Type 2), ASTM D 5151, ASTM D 6124. Powder-free. Non-conductive/passive barrier.

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.

Reference Devices

• K973461

Submission Summary (Full Text)

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2/26/99

Ansell Perry

K984559

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax:

Checklist Section 21.0

- 510 (k) Summary [1]
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646

330-833-2811 Telephone: [phone] Fax:

James R. Chatterton Contact: 330-833-2811 Telephone: Fax: [phone]

December 23, 1998

- Trade Name: Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) [3] Surgical Gloves, Green Polyurethane Common Name: Classification Name: Surgeon's Glove
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use), meet all of [4] the requirements of ASTM D 3577, Type 2.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) meet all the [ર] current specifications for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile િશ disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
- [7] Elite™ Powder Free Polyurethane 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 |

Ansell Healthcare Products Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.amsell.com Telephone: [phone] • Toll Free: 800-321-9752 (USA only) • Fax: [phone]

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K984559

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax:

Freedom from holes

.)

Meets ASTM D 3577 Meets ASTM D 5151

Powder-Free Meets described test in Attachment VI of K973461 Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization

Meets ASTM D 6124 Not more than 2 mg residue by mass.

Passes Passes

- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- (9) Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- [10] It is concluded that Elite™ Powder Free Polyurethane Synthetic 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.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646-7199

K984559 Re : Elite Powder-Free Polyurethane Synthetic Trade Name: Surgical Gloves (Chemotherapy Use) Requlatory Class: I Product Code: KGO Dated: December 23, 1998 December 23, 1998 Received:

Dear Mr. Chatterton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Chatterton

through 542 of the Act for devices under the Electronic enrough Size of Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deborizon substantial equivalence of your device to a legally Finding of babboandable results in a classification for your marketed production of mits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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3.0 Indications for Use Statement:

510(K) Number (if known): __

## INDICATIONS FOR USE

Ansell Perry Applicant: 1698 4559

Elite™ Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Device Name: _ 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Clim S. Lin
(Division Sign Off)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter