← Product Code [LZA](/productcode/LZA) · K982131 # NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K982131) _Ansell Edmont Industrial, Inc. · LZA · Oct 29, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K982131 ## Device Facts - **Applicant:** Ansell Edmont Industrial, Inc. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Oct 29, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs. ## Device Story Nitra-Touch™ is a powder-free nitrile medical examination glove. Designed for use by healthcare professionals to provide a barrier against contamination between the examiner and the patient. The device is also indicated for use when handling chemotherapy drugs. It is manufactured from nitrile film, which provides chemical resistance, including resistance to glutaraldehyde. The glove is disposable and worn on the hand. It offers higher tensile strength and puncture resistance compared to vinyl examination gloves. The device is intended for over-the-counter use. ## Clinical Evidence No clinical data provided. Evidence consists of non-clinical bench testing, including physical property testing (tensile strength, elongation), freedom from holes (ASTM D 5151), chemical resistance (ASTM F739-91), and biocompatibility (primary skin irritation and sensitization studies). ## Technological Characteristics Material: Nitrile. Powder-free. Dimensions and physical properties meet ASTM D 3578 (with specific variations in ultimate elongation). Freedom from holes meets ASTM D 5151. Chemical resistance tested per ASTM F739-91. Biocompatibility confirmed via rabbit skin irritation and guinea pig sensitization tests. ## 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}------------------------------------------------ K982131 Ansell Edmont Industrial Inc. Costincton OH 43812 Technology Center Telephone: (740) 623-3593 Technology Center Fax: (740) 623-3515 i Nitra-Touch™ Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: 740-622-4311 Fax: 740-623-3515 ## Checklist Section 21.0 OCT 2 9 1998 - 510 (k) Summary [1] - [2] Ansell Edmont Industrial, Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: 740-622-4311 740-623-3515 Fax: Contact: Mike W. Hagans Telephone: 740-623-3595 740-623-3515 Fax: June 12, 1998 | [3] | Trade Name: | Nitra-Touch™ | |-----|----------------------|---------------------------| | | Common Name: | Exam Gloves | | | Classification Name: | Patient Examination Glove | - Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with [4] the following variation. - Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 [ર] Rubber Examination Gloves except for the ultimate elongation percentage before and after aging. - [6] Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs. - [7] Nitra-Touch™ examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standard | |---------------------|-------------------| | Dimensions | Meets ASTM D 3578 | | Physical Properties | Meets ASTM D 3578 | {1}------------------------------------------------ K982131| Nitra-Touch™ Ansell Edmont Industrial. Inc. 1300 Walnut Street Coshocton, Ohio 43812 Telephone: 614-622-4311 Fax: 614-623-3515 Except Ultimate Elongation meets specifications described under Attachment II Freedom from holes Meets ASTM D 5151 Powder-Free Meets described test in Attachment V Original Ultimate Elongation 500% minimum Aged Ultimate Elongation 400% minimum Meets ASTM D 3578 - ASTM D 5250 ASTM D 3578 Not more than 2 mg residue by mass. Tensile Strength MPa Tensile Strength 60% higher than vinyl (synthetic) examination gloves Vinyl = 10.5 Nitra-Touch™ = 17.1 Puncture lbf/in Puncture resistance of Nitra-TouchTM is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves Glutaraldehyde Resistance Nitrile film provides excellent chemical resistance to glutaraldehyde. Permeation Rate = < 0.013 Fg/cm2 min Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization ASTM D 120-87 Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184 ASTM T F739-91 Source: TRI/Environmental, Inc. Breakthrough Time = >480 Passes Passes - [8] The performance test data of the non clinical tests are the same as mentioned immediately above. - ld] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. - It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and [10] perform as well as the glove performance standards referenced in Section 7 above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product. - This summary will include any other information reasonably deemed necessary by The [1]] FDA. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle symbol, which is a common emblem of the United States. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's full name and country. OCT 2 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Mike W. Hagans Ansell Edmont Industrial, Incorporated 1300 Walnut Street Coshocton, Ohio 43812 Re : K982131 Nitra-Touch™ Powder-Free Nitrile Medical Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: September 9, 1998 Received: September 21, 1998 Dear Mr. Hagans: 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Mr. Hagans 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". 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 {4}------------------------------------------------ 3.0 Indications for Use Statement: ## INDICATIONS FOR USE | Applicant: | Ansell Edmont Industrial, Inc. | |---------------------------|--------------------------------| | 510(K) Number (if known): | K982131 * | NITRA TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Device Name: | Patient Examination Glove | |--------------|---------------------------| |--------------|---------------------------| Indications For Use: 3 r 21 CFR 801.109 A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs. (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 | K982131 | |---------------|---------| |---------------|---------| | Prescription Use | OR | Over-The-Counter | X | |------------------|----|------------------|---| |------------------|----|------------------|---| --- **Source:** [https://fda-staging.innolitics.com/device/K982131](https://fda-staging.innolitics.com/device/K982131) **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. 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