← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K021465

# MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE (K021465)

_Industrial Clothings, Ltd. · LYY · May 22, 2002 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K021465

## Device Facts

- **Applicant:** Industrial Clothings, Ltd.
- **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md)
- **Decision Date:** May 22, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

## Device Story

Midas Touch™ Latex Examination Gloves are disposable, polymer-coated, powder-free gloves. Used by healthcare and similar personnel to provide a protective barrier on the hands, preventing cross-contamination between the examiner and the patient during clinical examinations or procedures. The device functions as a physical barrier.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Latex material; polymer coated; powder-free; disposable; non-sterile; includes protein labeling claim (100 micrograms or less).

## 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

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a row.

MAY 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Umair Ahmed Project Manager Industrial Clothings, Limited Prime Polymers Division 481A. Prince Of Wales Avenue Colombo 14, SRI LANKA

Re: K021465

Trade/Device Name: Midas Touch™ Latex Examination Gloves-Polymer Coated, Powder Free with Protein Labeling Claim (100 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 20, 2002 Received: May 7, 2002

Dear Mr. Ahmed:

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 vour 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. Umair Ahmed

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 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,

Architect

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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## Industrial Clothings Limited

(Prime Polymers Division) (11the 1 or enginsion for Latex Examination Glove – Polymer coated, Powder free

3.0 Indications for use

Applicant

KO21465

: Industrial Clothings Ltd. (Prime Polymers Division)

510(k) number Device name

: KOZ-1465

: Midas Touch™ Latex Examination Gloves - Polymer coated, Powder free WITH PROTEIN LABELING CLAIM (100 mic

Indications for use:

Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Clim S. Lim

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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K021465](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K021465)

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