← Product Code [LZA](/productcode/LZA) · K984311 # NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE (K984311) _Sumirubber Industries (Kedah) Sdn. Bhd. · LZA · Feb 9, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K984311 ## Device Facts - **Applicant:** Sumirubber Industries (Kedah) Sdn. Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Feb 9, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated. ## Device Story NBR 4 Mils Nitrile Powder-Free Examination Gloves are non-sterile, disposable protective barriers. Worn on hands by healthcare and similar personnel during patient care to prevent cross-contamination. Device functions as a physical barrier; no active components or software. Used in clinical or similar settings. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Nitrile rubber material; powder-free; non-sterile; 4 mil thickness; form-fitting glove design. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB g 1999 Mr. Hideaki Ochiai Sumirubber Industries (Kedah) Sdn. Bhd. Lot 44, 45 & 86, Bakar Arang Industrial Estate 08000 Sungai Petani, Kedah MALAYSIA Re : K984311 NBR 4 Mils Nitrile Powder-Free Examination Trade Name: Gloves Non-Sterile Requlatory Class: I Product Code: LZA Dated: November 20, 1998 December 2, 1998 Received: Dear Mr. Ochiai: 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. ਉ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Ochiai 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 acberibus in your in your device 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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general 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) 638-2021 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 {2}------------------------------------------------ ## INDICATIONS FOR USE : Mr. Hideaki Ochiai Applicant : NBR 4 Mils Nitrile Powder Free Examination Gloves Non-Device Name Sterile Indications for use : A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated. (PLEASE DO NOT TYPE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) | | signature | |---------------|---------------------------------------------------------------------| | | (Division Sign-Off) | | | Division of Dental, Infection Control, and General Hospital Devices | | 510(k) Number | K984311 | | Prescription Use | OR | Over-The-Counter | X | |------------------|----|------------------|---| |------------------|----|------------------|---| ## S-2 --- **Source:** [https://fda-staging.innolitics.com/device/K984311](https://fda-staging.innolitics.com/device/K984311) **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