← Product Code [LZA](/productcode/LZA) · K040607

# MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES (K040607)

_Pt. Medisafe Technologies · LZA · Apr 22, 2004 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K040607

## Device Facts

- **Applicant:** Pt. Medisafe Technologies
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Apr 22, 2004
- **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 made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use

## Device Story

Disposable synthetic rubber patient examination glove; worn on hands/fingers by healthcare personnel during examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Tested for resistance to chemotherapy agents. Used in clinical settings; no specialized operation required. Provides protection to both patient and clinician by reducing exposure to biological contaminants.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Material: Synthetic rubber (chloroprene). Form factor: Disposable examination glove. Tested for chemotherapy drug permeation. Class I medical device. Product code: LZA.

## 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 2 2004

Ms. Anil Taneja Vice President PT. MediSafe Technologies J1. Let. Jend. S. Parman No. 23 Medan 20153 INDONESIA

Re: K040607

Trade/Device Name: Modification to Powder-free Colored and Flavored Chloroprene Patient Examination Gloves, Tested for Chemo Use Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 10, 2004 Received: April 13, 2004

Dear Mr. Taneja:

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 cither 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.

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Page 2 - Mr. Taneja

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised mat I Da determination that your device complies with other requirements mean that I DT mas made statutes and regulations administered by other Federal agencies. or the receiver any I ouchar the Act's requirements, including, but not limited to: registration 1 ou inust comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and and listing (21 CF Part 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quardiation 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) I mis letter will anon you to objacting of substantial equivalence of your device to a premarket nottreation - I - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to roo pliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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 vours,

Kein Muly
for Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for MediSafe Technologies. The logo consists of a stylized letter "M" formed by three thick, black, angled lines. Below the symbol, the word "MediSafe" is printed in a bold, sans-serif font, with the word "TECHNOLOGIES" appearing in a smaller, lighter font underneath.

## PT. MediSafe TECHNOLOGIES

INDICATION FOR USE

: Medisafe Technologies Applicant 510(k) Number (if known) : Not Known : Examination Gloves Device Name Indications For Use : A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

940

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martha T. O'Lone

(Division Sign-C (Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Device

510(k) Number

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**Source:** [https://fda.innolitics.com/device/K040607](https://fda.innolitics.com/device/K040607)

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