ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE

K973461 · Ansell Perry · KGO · Dec 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973461
• Device Name: ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 9, 1997
• 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 devices designed for use by operating room personnel. The gloves act as a protective barrier to prevent contamination of surgical wounds. They are manufactured from polyurethane synthetic rubber and are powder-free to reduce potential residue. The device is used in clinical surgical settings. Healthcare providers wear the gloves during procedures to maintain sterile fields and protect both the patient and the clinician. The device is evaluated against ASTM D 3577 standards for physical properties and dimensions, ensuring performance equivalent to standard rubber surgical gloves.

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 testing included primary skin irritation in rabbits and guinea pig sensitization, both of which passed.

Technological Characteristics

Material: Polyurethane synthetic rubber. Form factor: Sterile, disposable surgical glove. Standards: Meets ASTM D 3577 (Type 2), ASTM D 5151, and ASTM D 6124. Powder-free (residue ≤ 2 mg). Biocompatibility: Passes primary skin irritation and guinea pig sensitization tests.

Indications for Use

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

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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K973461

Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: --330-833-6213 Fax:

Checklist Section 21.0

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

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

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

September 10, 1997

- [3] Trade Name: Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of [4] ASTM D 3577, Type 2.
- (૨) Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices [6] 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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K973461

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

> Meets ASTM D 3577 Meets ASTM D 5151

Powder-Free Meets described test in Attachment VI Meets ASTM D 6124 Not more than 2 mg residue by mass.

Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization

Freedom from holes

Passes Passes

- [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
- (di Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are as safe, as [10] 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. [11]

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Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

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

Re : K973461 Elite Powder Free Polyurethane Synthetic Trade Name: Surqical Glove Requlatory Class: I Product Code: KGO November 12, 1997 Dated: November 14, 1997 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 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 current Good Manufacturing Practice requirement, 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 regulation 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

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Page 2 - Mr. Chatterton

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation 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 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

K. Watro

Timothy | 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

| Applicant: | Ansell Perry |
|---------------------------|--------------|
| 510(K) Number (if known): | K97 3461 |

Surgeon's Glove, powder free, polyurethane Device Name:

Indications For Usc.

A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Neeraj A. Mehelfer Chin S. Zin Ph.D

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ×97346

510(k) Number.

OR

Over-The-Counter

Prescription Use Per 21 CFR 801,109

(Optional Format 1-2-96)