ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)

K983489 · Ansell Perry · KGO · Dec 14, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983489
• Device Name: ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 14, 1998
• 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 Mark IV Powder Free Surgical Gloves are sterile, disposable natural rubber latex gloves. Designed for use by operating room personnel to protect surgical wounds from contamination. Device features a polymer coating and is powder-free, with a specific labeling claim of 50 micrograms or less of total water-extractable protein per gram. Used in clinical/surgical settings to provide a barrier between the clinician and the patient. Benefits include reduced risk of wound contamination and lower potential for protein-related allergic reactions due to the low-protein content.

Clinical Evidence

No clinical data. Performance is supported by non-clinical bench testing, including ASTM D 3577 (physical properties, dimensions), ASTM D 5151 (freedom from holes), ASTM D 6124 (powder-free residue), and biocompatibility testing (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Natural rubber latex surgical glove; polymer coated; powder-free. Meets ASTM D 3577 (Type 1) for dimensions and physical properties. Meets ASTM D 5151 for freedom from holes and ASTM D 6124 for powder residue (<= 2 mg). Protein content <= 50 micrograms/gram. Sterile, disposable.

Indications for Use

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

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

DEC | 4 1998

K983489

Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax:

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 |

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

September 30, 1998

- Trade Name: Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) [3] Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1.
- [૨] Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- [୧] Encore Mark IV 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 Mark IV 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 |

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

Encore Mark IV 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 ASTM D 6124 |
| Meets described test in Attachment VI | Not more than 2 mg residue by mass. |
| Protein Label Claim | This latex glove contains 50 micrograms or<br>less of total water extractable protein per<br>gram. |
| Biocompatability | |
| Primary Skin Irritation in Rabbits | Passes |

The performance test data of the non clinical tests are the same as mentioned immediately above. [8]

Passes

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

Guinea Pig Sensitization

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

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

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 1998

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

K983489 Re : Encore Mark IV Powder-Free Polymer Coated Trade Name: Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: KGO Dated: September 30, 1998 Received: October 5, 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 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 requlations 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 Requlation (QS) for Medical General requlation (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 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

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

Page 2 - Mr. Chatterton

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.qov/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 Radiological Health

Enclosure

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

3.0 Indications for Use Statement:

## INDICATIONS FOR USE

| Applicant: | Ansell Perry |
|---------------------------|---------------------------------------------------------------------------------------------------|
| 510(K) Number (if known): | K983489 * |
| Device Name: | Surgeons Glove, latex polymer coated, powder free with protein label claim (50 microGRAM OR LESS) |
| Indications For Use: | |

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

ア

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

Concurrence of CDRH Office of Device Evaluation (ODE)

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

OR

Prescription Use L `1 CFR 801.109

Over-The-Counter

er X

---

(Optional Format 1-2-96)