← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K020918

# ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE (K020918)

_Eci Medical Technologies, Inc. · KGO · Apr 19, 2002 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K020918

## Device Facts

- **Applicant:** Eci Medical Technologies, Inc.
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** Apr 19, 2002
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Intended Use

A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

## Device Story

Elastyfree™ is a disposable, synthetic, powder-free surgical glove. Used in surgical settings by healthcare professionals to provide a protective barrier against infectious materials and contaminants. Device functions as a physical barrier worn on the hands.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Synthetic material; powder-free; disposable; form factor is a surgical glove.

## Regulatory 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 9 2002

Ms. Shirantha Samarappuli Quality Assurance Manager ECI Medical Technologies, Incorporated 2 Cook Road Bridgewater, Nova Scotia, CANADA B4V 3W7

Re: K020918

Trade/Device Name: Elastyfree™ Synthetic Powder-Free Surgical Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 19, 2002 Received: March 21, 2002

Dear Ms. Samarappuli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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## Page 2 - Ms. Samarappuli

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/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

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Elastyfree Synthetic Powder Free Surgical Glove ECI Medical Technologies Inc 2, Cook Road Bridgewater, NS Canada B4V 3W7 Tel; 902 543 6665 Fax: 902 543 6644

CONFIDENTIAL
& PROPRIETARY

APR 1 9 2002

Attachment 1

## Indications for Use Statement

18

510(k) Number:

Elastyfree™ Synthetic Powder-Free Surgical Glove Device Name: _

Indications for Use:

A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Olin S. Lin

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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K020918](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K020918)

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