← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K991686 # LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) (K991686) _Arista Latindo Industrial Ltd. P.T · LYY · Jun 11, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K991686 ## Device Facts - **Applicant:** Arista Latindo Industrial Ltd. P.T - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Jun 11, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. ## Device Story Device is a powder-free natural latex examination glove. Used by healthcare professionals during patient examinations to provide a barrier against contamination. Device is disposable and worn on the hand or finger. Benefits include reduced risk of cross-contamination between patient and examiner. Protein content is labeled as 50 mcg or less of extractable protein. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Natural latex material; powder-free; disposable; form-fitted for hand/finger; protein content labeled at 50 mcg or less extractable protein. ## 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. ## Predicate Devices - [K921389](/device/K921389.md) ## 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}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 1 1999 Linga Sumarta Arista® Latindo Industrial, LTD. P.T 128 Jalan Kyai Haji Muhammad Mansyur Jakarta Barat INDONESIA 11210 K991686 Re : Trade Name: Latex Examination Gloves, Powder Free with Protein Labeling Claim, (50 mcg or less) Regulatory Class: I Product Code: LYY Dated: May 17, 1999 Received: May 17, 1999 ## Dear Ling Sumarta: 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 reqistration, 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 requlations 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) regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 — Linga Sumarta Please note: this response to your premarket notification Ficase note: "chirot affect any obligation you might have under Submission accb 1100 as 2010 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA debeing of substantial equivalence of your device to a legally rinatig or babbomotevice results in a classification for your markets produces 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 ene promoe of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to the regulacion entitica, "Hibbranding by solors general information on your responsibilities under the Act may be Information on Jo 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 Radioloqical Health Enclosure {2}------------------------------------------------ ## SISTA LATINDO INDUSTRIAL LTD. P.T GLOVES MANUFACTURING OFFICE : JL. K.H. MOH. MANSYUR 120 - INDONESIA MAILING ADDRESS : P.O. BOX 4129 JKT 11041 · INDONES TELEPHONE : (021) 639-1907 (4 LINES) FAX : (62-21) 639-4691, 874-0979, 669-0428 TELEX : 42004 NIKKO 1A. Section No. 3. ## ATTACHMENT #2 ## INDICATIONS FOR USE STATEMENT | Applicant: | PT. ARISTA LATINDO IND. LTD. | |---------------------------|-----------------------------------------------------------------------| | 510(k) Number (if known): | modification K921389 * | | Device Name: | Powder Free Natural Latex Examination Gloves with Protein Label Claim | | Indications For Use: | (50mcg or less EXTRACTABLE PROT | A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxamincr. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Usc Per 21 CFR 801.109 OR Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ (Optimal Format 1-2-96) Basin for Oil (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -Kgg 1686 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K991686](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K991686) **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