← Product Code [LZA](/productcode/LZA) · K122453

# MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY (K122453)

_Industrial Clothings, Ltd. · LZA · Apr 5, 2013 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K122453

## Device Facts

- **Applicant:** Industrial Clothings, Ltd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Apr 5, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

## Device Story

Midas Touch™ Nitrile Examination Gloves are disposable, powder-free, grey nitrile gloves. Designed for use by clinicians or examiners to provide a protective barrier between the examiner's hand and the patient, preventing cross-contamination. The gloves feature a textured finger surface to improve grip. Available in four sizes (Small, Medium, Large, X-large). Used in clinical or medical settings as a standard personal protective equipment (PPE) item. The device functions as a physical barrier; no electronic or mechanical components are involved.

## Clinical Evidence

No clinical data. Bench testing only.

## Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powder-free, grey, finger-textured examination glove. Sizes: Small, Medium, Large, X-large. Regulatory class: I. Product code: LZA. No electronic components, software, or energy sources.

## 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is rendered in a thick, black line, and the text is in a simple, sans-serif font. The overall design is clean and professional.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## April 5, 2013

Mr. S. N. Hari Deputy General Manager Industrial Clothings Limited, Prime Polymers Division D-17, Seethawaka Export Processing Zone Auissawella, Western Province Sri Lanka 10700

Re: K122453

Trade/Device Name: Midas Touch™ - Nitrile Examination Gloves - Powder Free, Grey Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I ' Product Code: LZA Dated: March 22, 2013 Received: April 1, 2013

Dear Mr. Hari:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Hari

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely vours.

for

{

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Respiratory, 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 "MIDAS SAFETY". The logo consists of a stylized hand graphic on the left, followed by the word "MIDAS" in large, bold letters. Below "MIDAS" is the word "SAFETY" in smaller letters. Underneath the words is a line, and below the line is the phrase "INNOVATIVE SAFETY SOLUTIONS".

Industrial Clothings Limited (Prime Polymers Division)

510(k) Submission for Grey Nitrile Examination Gloves - Powder free

## INDICATIONS FOR USE

| Applicant                                       | : Industrial Clothings Ltd., Prime Polymers Division                                                                                                                                                                                                                                                           |                                                  |  |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--|
| 510(k) number (if known)                        | : K122453                                                                                                                                                                                                                                                                                                      |                                                  |  |
| Device name                                     | : Midas Touch™ - Nitrile Examination Gloves -<br>Powder free, Grey                                                                                                                                                                                                                                             |                                                  |  |
| Indications for use                             | : A powder-free examination glove is a disposable<br>device intended for medical purposes, that is worn on<br>the examiner's hand or finger to prevent<br>contamination between patient and examiner.<br>Gloves are available with finger textured surface in<br>four sizes; Small, Medium, Large and X-large. |                                                  |  |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR                                                                                                                                                                                                                                                                                                         | Over-The-Counter Use √<br>(21 CFR 801 Subpart C) |  |

A

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria Cruz-fisher
Digitally signed by Maria Cruz-fisher
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA,
ou=People, cn=Maria Cruz-fisher,
0.9.2342.19200300.100.1.1=2000576169
Date: 2013.04.04 14:28:18 -04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | 4122453 |
|----------------|---------|
|----------------|---------|

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**Source:** [https://fda-staging.innolitics.com/device/K122453](https://fda-staging.innolitics.com/device/K122453)

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