ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE

K981392 · Ansell Perry · KGO · May 11, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981392
• Device Name: ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 11, 1998
• 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.

Device Story

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile, disposable, green-colored synthetic rubber gloves. Used by operating room personnel to provide a protective barrier against contamination of surgical wounds. Device is worn on the hands during surgical procedures.

Clinical Evidence

No clinical data; bench testing only. Device meets ASTM D 3577, Type 2 specifications for physical properties and dimensions.

Technological Characteristics

Material: Polyurethane synthetic rubber. Form factor: Sterile, disposable surgical glove. Standards: Meets ASTM D 3577, Type 2. No software or electronic components.

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination.

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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K981392

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax:

Checklist

Section 21.0

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

Telephone: [phone] Fax:

James R. Chatterton Contact: Telephone: [phone] Fax:

September 10, 1997

- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves [3] Trade Name: Surgical Gloves, Green Polyurethane Common Name: Surgeon's Glove Classification Name:
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of [4] ASTM D 3577, Type 2.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications (5) for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices િ intended to be worn by operating room personnel to protect a surgical wound from contamination.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are summarized with the following [7] technological characteristics compared to ASTM or equivalent standards.

Characteristics Standard Dimensions Meets ASTM D 3577 Physical Properties Meets ASTM D 3577, Type 2

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | | |998

Mr. James R. Chatterton Vice President Regulatory Affairs, Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646

K981392 Re : Elite Mark IV Sterile Powder-Free Trade Name: Polyurethane Synthetic Surgical Gloves (Green) Requlatory Class: I Product Code: KGO Dated: April 9, 1998 Received: April 17, 1998

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 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 controls provisions The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify *such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Chatterton

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (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" (21 CFR 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/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 Radiological Health

Enclosure

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## 3.0 Indications for Use Statement:

## INDICATIONS FOR USE

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Surgeon's Glove, powder free, polyurethane, green color 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.

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Concurrence of CDRH Office of Device Evaluation (ODE)

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Divisional, Infection Control,
and General Hospital Devices
510(k) Number κ981372
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Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter