ELASTYREN POWDER-FREE SURGICAL GLOVE

K971471 · Eci Medical Technologies, Inc. · KGO · Feb 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K971471
• Device Name: ELASTYREN POWDER-FREE SURGICAL GLOVE
• Applicant: Eci Medical Technologies, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Elastyren Powder-Free Surgical Glove; device composed of natural or synthetic rubber. Worn by operating room personnel during surgical procedures. Primary function: barrier protection to prevent contamination of surgical wounds. Device serves as protective equipment in clinical/surgical environments.

Clinical Evidence

No clinical data provided; substantial equivalence based on device classification and intended use as a standard surgical glove.

Technological Characteristics

Material: natural or synthetic rubber. Form factor: surgical glove. Powder-free. Class I medical device.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Suitable for use as a surgeon's 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Forer Executive Vice President ECI Medical Technologies, Incorporated 2 Cook Road Bridgewater, Nova Scotia, CANADA

FEB - 9 1998

K971471 Re: Elastyren Powder-Free Surgical Glove Trade Name: Regulatory Class: I Product Code: KGO December 18, 1997 Dated: Received: December 23, 1997

Dear Mr. Forer:

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 aqainst 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 Devices: General regulation (21 CFR Part 820) and that, 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. Forer

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,
Alilatra

hy A. Ulatowski Timo 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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Page

510(k) Number (1) known): K97147 | Powder -- 160 Device Name: Indications For Use:

A surgeon's glove is a device made of natural or systemic rubber insended to be worn by operating room personnel to protect a surgical wound from contamination.

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Concu rence of CDRH, Office of Device Evaluation (ODE)

*Chùm Silam*
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *[2971471]*

Prescription Use***_****_* OR Over-The-Counter Use *X*
(Per 21 CFR 801.109)

(Optional Format 1-2-96)