← Product Code [LZA](/productcode/LZA) · K970015

# ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES (K970015)

_Eci Medical Technologies, Inc. · LZA · Jun 24, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K970015

## Device Facts

- **Applicant:** Eci Medical Technologies, Inc.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jun 24, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## Device Story

Elastyren Powder-Free Patient Examination Glove is a disposable, non-sterile, patient examination glove. Used by healthcare professionals to provide a protective barrier on the hand or finger, preventing cross-contamination between the examiner and the patient. Device is intended for general medical examination purposes.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Disposable patient examination glove. Powder-free. Material composition not specified. Class I device subject to general controls.

## Regulatory Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

JUN 24 1997

Re: K970015
Trade Name: Elastyren Powder-Free Patient Examination
Gloves
Regulatory Class: I
Product Code: LZA
Dated: April 17, 1997
Received: April 18, 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Forer

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 regulation (21 CFR Part 801 and additionally 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" (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 (800) 638-2041 or at (301) 443-6597.

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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MAY-26-97 11:52 FROM:Corporate - M. Foref
ID:416 222 2194
PAGE 2/2

Page 1 of 1

510(k) Number (if known): K970015

Device Name: Elastyren Powder-Free Patient Examination Glove

Indications For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(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 K970015

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑
(Optional Format 1-2-96)

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**Source:** [https://fda-staging.innolitics.com/device/K970015](https://fda-staging.innolitics.com/device/K970015)

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