← Product Code [LZA](/productcode/LZA) · K060073 # TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING (K060073) _Shen Wei (Usa), Inc. · LZA · May 1, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K060073 ## Device Facts - **Applicant:** Shen Wei (Usa), Inc. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** May 1, 2006 - **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 purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR880.6250) This device is not intended to be used as a chemical barrier. ## Device Story Textured (fingers and palm) powder-free nitrile exam glove; black color. Disposable device worn on examiner's hands or fingers; serves as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or medical settings; operated by healthcare professionals or individuals for personal protection. Not intended for chemical barrier protection. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Nitrile rubber. Form factor: Disposable glove with textured fingers and palm. Color: Black. Powder-free. Non-sterile. ## 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 seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 2006 Ms. Cynthia Liu Director of Marketing Shen Wei (USA) Incorporated 33278 Central Avenue, Suite #102 Union City, California 94587 Re: K060073 Trade/Device Name: Textured (Fingers & Palm) Powder Free Nitrile Exam Gloves (Black Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 20, 2006 Received: April 24, 2006 Dear Ms. Liu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Ms. Liu Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mean that 1 DT mas may Federal statutes and regulations administered by other Federal agencies. of the Act of ary I outhal the Act's requirements, including, but not limited to: registration r od intex compy - Allering (21 CFR Part 801); good manufacturing practice and ilsuing (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) Fins feter while will and you 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), rr you donto t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj volum of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.goy/cdrh/industry/support/index.html. Sincerely yours, Genette Y. Michie Oms Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K060073 Device Name: Textured (Fingers & Palm) Powder Free Nitrile Exam Gloves (Black color) Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR880.6250) This device is not intended to be used as a chemical barrier. Prescription Use (Part 21 CFR 801 Subpart D) i i ... AND/OR X Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shula A. Murphy, K 4/28/04 Ingy, Ganeral H Page 1 of --- **Source:** [https://fda-staging.innolitics.com/device/K060073](https://fda-staging.innolitics.com/device/K060073) **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