← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K982453 # NON-STERILE E.P. LATEX EXAMINATION GLOVE (K982453) _Ansell Perry · LYY · Nov 30, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K982453 ## Device Facts - **Applicant:** Ansell Perry - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Nov 30, 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 purpose that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs. ## Device Story Non-sterile, powder-free latex examination gloves; worn by healthcare examiners to provide a protective barrier; prevents cross-contamination between patient and examiner; suitable for handling chemotherapy drugs; disposable; single-use. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing, including physical properties, dimensions, freedom from holes (ASTM D 5151), powder residue (ASTM D 6124), and biocompatibility (primary skin irritation and guinea pig sensitization). ## Technological Characteristics Latex material; powder-free; dimensions and physical properties meet ASTM D 3578; freedom from holes meets ASTM D 5151; powder residue meets ASTM D 6124 (not more than 2 mg residue by mass); 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}------------------------------------------------ **Ansell Perry** K 98 2453 Checklist Section 21.0 ﺔ ﺍﻟﻤﺪﻳﻨﺔ [1] 510 (k) Summary - [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 Fax: 330-833-6213 James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6213 July 13, 1998 - Trade Name: Non-Sterile E.P. Latex Examination Gloves [3] Common Name: Examination Gloves Classification Name: Patient Examination Glove - Non-Sterile E.P. Latex Examination Gloves, meet all of the requirements of ASTM D 3578. [4] - Non-Sterile E.P. " Latex Examination Gloves meet all the current specifications for ASTM D [ર] 3578 Rubber Examination Gloves. - Non-Sterile E.P. ® Latex Examination Gloves are non-sterile disposable devices intended for [6] medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. - Non-Sterile E.P. ® Latex Examination Gloves are summarized with the following technological [7] characteristics compared to ASTM or equivalent standards. Characteristics Standard Dimensions Meets ASTM D 3578 Physical Properties Meets ASTM D 3578 81 Ansell Perry Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.ansell.com Telephone: 330-833-2811 • Toll Free: 800-321-9752 (USA only) • Fax: 330-833-5991 Non-Sterile E.P. Latex Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: {1}------------------------------------------------ ## K982453 Non-Sterile E.P. Latex Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax: Meets ASTM D 3578 Meets ASTM D 5151 Freedom from holes Powder-Free Meets described test in Attachment VIII Meets ASTM D 6124 Not more than 2 mg residue by mass. Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization Passes Passes The performance test data of the non clinical tests are the same as mentioned immediately above. [8] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. (9) - [10] It is concluded that Non-Sterile E.P. Latex Examination Gloves are as safe, as effective, and 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 FDA. [11] {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 30 1998 Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646 Re: K982453 Non-Sterile E.P.® Latex Examination Glove Trade Name: Requlatory Class: I Product Code: LYY October 15, 1998 Dated: Received: October 19, 1998 Dear Mr. Chatterton: 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 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {3}------------------------------------------------ Paqe 2 - Mr. Chatterton through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 regulation (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 comprisines as (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 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/dsma/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}------------------------------------------------ ## INDICATIONS FOR USE | Applicant: | Ansell Perry | |-----------------------------|-----------------------------------------------------------| | 510(K) Number (if known): * | K982453 | | Device Name: | LATEX Patient Examination Glove, Powder Free, Beige Color | Indications For Use: A disposable device intended for medical purpose 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) Olin S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Over-The-Counter (Optional Format 1-2-96) ription Use 'er 21 CFR 801.109 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K982453](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K982453) **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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