SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)

K980880 · Ansell Perry · KGO · May 20, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980880
• Device Name: SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
• Applicant: Ansell Perry
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 20, 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

Sensi-Derm® Latex Surgical Gloves are sterile, disposable natural rubber gloves. Designed for use by operating room personnel to provide a barrier protecting surgical wounds from contamination. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical surgical settings.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing per ASTM D 3577 and freedom from holes testing per ASTM D 5151.

Technological Characteristics

Material: Natural rubber. Dimensions and physical properties meet ASTM D 3577, Type 1. Freedom from holes meets ASTM D 5151. Biocompatibility: Passes primary skin irritation and guinea pig sensitization tests. Sterile, disposable.

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)

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## K980880

Sensi-Derm® Latex Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] Fax:

MAY 20, 1998

Checklist Section 21.0

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

> Telephone: [phone] Fax: [phone]

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

March 3, 1998

- [3] Trade Name: Sensi-Derm® Latex Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Sensi-Derm® Latex Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. [4]
- [2] Sensi-Derm® Latex Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- [୧] Sensi-Derm® Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Sensi-Derm® Latex Surgical Gloves 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 |

83

129

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Sensi-Derm® Latex Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: [phone] 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]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [୨]
- It is concluded that Sensi-Derm® Latex Surgical Gloves are as safe, as effective, and perform as [10] 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

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

Re : K980880 Sensi-Derm® Latex Surgical Gloves Trade Name: (Powdered) , Brown Color Regulatory Class: I Product Code: KGO March 3, 1998 Dated: Received: March 9, 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 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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Chatterton

through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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" (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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy 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

| Applicant: | Ansell Perry, Inc. |
|---------------------------|----------------------------------------------|
| 510(K) Number (if known): | K980880 * |
| Device Name: | Surgeons Glove, Latex Brown Color (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)

Chis S. him
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980850

Prescription Use Per 21 CFR 801.109 Over-The-Counter