← Product Code [LZA](/productcode/LZA) · K990299 # POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES (K990299) _Shanghai Palomar Mountain Industries, Inc. · LZA · Mar 29, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K990299 ## Device Facts - **Applicant:** Shanghai Palomar Mountain Industries, Inc. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Mar 29, 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 copolymer nitrile medical examination glove. Used in clinical settings by healthcare professionals to provide a protective barrier between the examiner and the patient. Function is to prevent cross-contamination during medical examinations. Device is disposable and worn on the hand or finger. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Copolymer nitrile. Form factor: Disposable examination glove. Powder-free. Class I medical device. ## 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 eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 9 1000 Mr. Danny Wang Sales Manager Shanghai Palomar Mountain Industries, Incorporated #1 BIYU Road Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C. Re : K990299 Powder-Free Copolymer Nitrile Medical Trade Name: Examination Gloves Regulatory Class: I Product Code: LZA October 30, 1998 Dated: Received: February 1, 1999 Dear Mr. Wang 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 Existing major be subject to such additional controls. 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) 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Wang 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 acberized in betantial equivalence of your device to a legally marketed predicate device results in a classification for your markets production of mits 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 ene office or compliand, "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 {2}------------------------------------------------ - 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page, The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement. ## INDICATIONS FOR USE Applicant: SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. 510(k) Number (if known): * K GU Device Name: POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED. 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96) Over-The-Counte For a new submission, do NOT fill in the 510(k) number blank. ★ Risa S. Lin Dental, Infection Co --- **Source:** [https://fda-staging.innolitics.com/device/K990299](https://fda-staging.innolitics.com/device/K990299) **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