MEDI-GRIP (BEIGE 43)SURGICAL GLOVES

K980564 · Ansell Perry · KGO · Mar 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980564
• Device Name: MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Medi-Grip (Beige 43) Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, disposable natural rubber latex surgical gloves; worn by operating room personnel to protect surgical wounds from contamination. Device functions as a physical barrier between the clinician and the patient. No electronic, software, or algorithmic components. Used in surgical settings.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing per ASTM D 3577, freedom from holes per ASTM D 5151, and biocompatibility testing (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Natural rubber latex surgical glove. Meets ASTM D 3577 (Type 1) for dimensions and physical properties. Meets ASTM D 5151 for freedom from holes. Biocompatible (passes primary skin irritation and sensitization). Sterile, disposable.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Device is a natural rubber latex glove.

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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Medi-Grip (Beige 43) Surgical Gloves Ansell Perry 1875 Harsh Avenue SE MAR 25 1998 Massillon, Ohio 44646 Telephone: [phone] Fax:

MAR 25 1998

Checklist Section 21.0

K980564

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

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

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

February 10, 1998

- Medi-Grip (Beige 43) Surgical Gloves [3] Trade Name: Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Medi-Grip (Beige 43) Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. [4]
- Medi-Grip (Beige 43) Surgical Gloves meet all the current specifications for ASTM D 3577 [ર] Rubber Surgical Gloves.
- Medi-Grip (Beige 43) Surgical Gloves are sterile disposable devices intended to be worn by [୧] operating room personnel to protect a surgical wound from contamination.
- Medi-Grip (Beige 43) Surgical Gloves are summarized with the following technological [7] characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|---------------------|---------------------------|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 1 |

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Medi-Grip (Beige 43) Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: --330-833-2811 330-833-6213 Fax:

Freedom from holes

Meets ASTM D 3577 Meets ASTM D 5151

Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization

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.
- It is concluded that Medi-Grip (Beige 43) Surgical Gloves are as safe, as effective, and perform [10] 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. [11]

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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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 25 1998

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

Re : K980564 Medi-Grip (Beige 43) Powdered Latex Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO February 10, 1998 Dated: Received: February 13, 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, Druq, and Cosmetic Act (Act). 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 (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) requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 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 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" (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

hv A 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

| Annlicant's | | A collected and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | -------------- | | |
|-------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------|---|--|
| | 510(K) Number (if known): | CARANA | | | 1 | |
| | | | | | | |

Device Name: Surgeons Glove, Latex (powdered)

Indications For Use:

A device made of natural 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) -------

Qilin S. Lin
(Division Sign-Off)

(Division of Dental, Infection Control,
and General Hospital, Infection Control, and General Hospital Infection 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

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