SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM

K992953 · Ansell Perry · KGO · Oct 29, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992953
• Device Name: SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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

Device Story

Encore Orthopaedic Powder Free Surgical Gloves are sterile, disposable natural rubber latex gloves. Designed for use by operating room personnel to provide a barrier against contamination of surgical wounds. The gloves are powder-free and feature a protein labeling claim of 50 micrograms or less of total water extractable protein per gram. They are intended for use in surgical environments to protect both the patient and the clinician.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D 3577 (dimensions, physical properties), ASTM D 5151 (freedom from holes), and ASTM D 6124 (protein residue). Biocompatibility testing (primary skin irritation in rabbits and guinea pig sensitization) passed.

Technological Characteristics

Material: Natural rubber latex. Form factor: Powder-free surgical glove. Standards: ASTM D 3577 (Type 1), ASTM D 5151, ASTM D 6124. Protein content: ≤ 50 micrograms/gram. 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.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the words "Ansell Perry" in a bold, sans-serif font. The word "Ansell" is in white on a black background, while the word "Perry" is in black on a white background. The two words are side-by-side, creating a contrast between the colors.

OCT 2 9 1999

Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits. The digits are 9, 9, 2, 9, 5, and 3. The numbers are written in a casual, slightly uneven style, with varying stroke thicknesses. The digits are arranged horizontally, with slight spacing between them.

Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: Fax: [phone]

Checklist Section 21.0

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

| Telephone: | 330-833-2811 |
|------------|--------------|
| Fax: | 330-833-6213 |

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

August 31, 1999

- Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) Trade Name: [3] Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the [4] requirements of ASTM D 3577, Type 1.
- Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current [૨] specifications for ASTM D 3577 Rubber Surgical Gloves.
- (୧) Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) 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 1 |

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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a sequence of handwritten digits. The digits appear to be '992953'. The numbers are written in a casual, slightly uneven style, with varying stroke thicknesses. The background is plain white.

Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) 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

Protein Label Claim

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

This latex glove contains 50 micrograms or less of total water extractable protein per gram.

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. 181
- [9] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) [10] 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Mr. James R. Chatterton Vice President Requlatory Ansell Perry Ansell Healthcare Products, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646

Re : K992953 Trade Name: Encore Orthopaedic Powder Free Surqical Gloves (Protein Labeling Claim), 50 Micrograms or Less Regulatory Class: I …… Product Code: KGO Dated: August 31, 1999 Received: September 1, 1999

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 reqistration, 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 Regulations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in

{3}------------------------------------------------

Paqe 2 - Mr. Chatterton

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 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

{4}------------------------------------------------

## INDICATIONS FOR USE

| Applicant: | Ansell Perry |
|---------------------------|----------------------------------------------------------------------------------|
| 510(K) Number (if known): | K992953 * |
| Device Name: | Surgeons Glove, brown latex polymer coated, powder free with protein label claim |
| Indications For Use: | (50 MICROGRAMS OR LESS) |

A device made of natural 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)

Prescription Use Per 21 CFR 801.109

Olin S. Lìm

OR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 5 : 0(k) Number _

Over-The-Counter

(Optional Format 1-2-96)