← Product Code [LZA](/productcode/LZA) · K122464 # MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE (K122464) _Industrial Clothings, Ltd. · LZA · Apr 12, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K122464 ## Device Facts - **Applicant:** Industrial Clothings, Ltd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Apr 12, 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 nitrile gloves designed for medical examination use. They serve as a protective barrier worn on the hands or fingers of healthcare personnel to prevent cross-contamination between the examiner and the patient. The gloves feature a finger-textured surface for improved grip and are available in four sizes (Small, Medium, Large, X-large). They are intended for use in clinical or medical settings by healthcare professionals. ## Clinical Evidence No clinical data provided; substantial equivalence is based on bench testing and compliance with established standards for patient examination gloves. ## Technological Characteristics Material: Nitrile rubber. Form factor: Disposable, powder-free, finger-textured surface. Sizes: Small, Medium, Large, X-large. Regulatory Class: I. 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 12, 2013 Mr. S. N. Hari Deputy General Manager Industrial Clothings, Limited D-17, Seethawaka Export Processing Zone Avissawella Western Province Sri Lanka 10700 Re: K122464 Trade/Device Name: Midas Touch™ Nitrile Examination Gloves- Powder-Free, Orange 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. {1}------------------------------------------------ Page 2 - Mr. S. N. 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 device-related 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/default.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/Industry/default.htm. Sincerely vours, for Ruth Lurotms. 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for "MIDAS SAFETY INNOVATIVE SAFETY SOLUTIONS". The logo features 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, and below that is the phrase "INNOVATIVE SAFETY SOLUTIONS". Industrial Clothings Limited (Prime Polymers Division) 510(k) Submission for Orange Nitrile Examination Gloves - Powder free ## INDICATIONS FOR USE | Applicant | : Industrial Clothings Ltd., Prime Polymers Division | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number (if known) | : K122464 | | Device name | : Midas TouchTM - Nitrile Examination Gloves -
Powder free, Orange | | 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. | | Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use ✓
(21 CFR 801 Subpart C) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | Maria Cruz-
fisher
(Division Sign-Off) | 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: 2013.04.11 16:56:12 -04'00' | | | Division of Anesthesiology, General Hospital
Infection Control, Dental Devices | | 510(k) Number: | K122464 | ONPF K122464 R122404 . : . · . ·············································································································································································· . . ... . · ﺃ :: : ... : : --- **Source:** [https://fda-staging.innolitics.com/device/K122464](https://fda-staging.innolitics.com/device/K122464) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com