← Product Code [LZA](/productcode/LZA) · K011961 # POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 (K011961) _Shen Wei (Usa), Inc. · LZA · Sep 26, 2001 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K011961 ## Device Facts - **Applicant:** Shen Wei (Usa), Inc. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Sep 26, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Powder-Free Butadiene Copolymer Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This product has a pH of 5.5, which is an integral part of this patented product. This is not an antimicrobial/antiseptic glove. This device is not intended to be used as a chemical barrier. ## Device Story Powder-Free Butadiene Copolymer Examination Gloves are disposable, violet-colored gloves worn by healthcare personnel during patient examinations. The device acts as a physical barrier to prevent cross-contamination between the examiner and the patient. The gloves feature a pH of 5.5 as an integral design component. The device is intended for general medical use and is not indicated for use as a chemical barrier or as an antimicrobial/antiseptic agent. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Butadiene copolymer. Form factor: Disposable examination glove. Color: Violet. pH: 5.5. Non-sterile, powder-free. ## 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## SEP 2 6 2001 Ms. Belle L. Chou General Manager Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587 Re: K011961 Trade/Device Name: Powder-Free Butadiene Copolymer Examination Gloves with Aloe, Violet Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 9, 2001 Received: August 13, 2001 Dear Ms. Chou: 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. 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 {1}------------------------------------------------ Page 2 - Ms. Chou of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 534-542 of the Act; 21): CFR 1000-1050. 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) 594-4618. Additionally, for questions on the promotion and 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, International and Consumer 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. Lis Matant 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for Shen Wei Inc. The logo consists of a stylized letter "S" formed by two curved shapes, one above the other. Below the symbol, the text "SHEN WEI INC." is arranged vertically, with each word stacked on top of the other. K011961 ## Attachmont Two ## INDICATION FOR USE Applicant: Shen Wei (USA) Inc. Device Name: Powder-Free Butadiene Copolymer Examination Gloves, Violet Color Indication For Use: Powder-Free Butadiene Copolymer Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This product has a pH of 5.5, which is an integral part of this patented product. This is not an antimicrobial/antiseptic glove. This device is not intended to be used as a chemical barrier. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Qlin S. lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number Prescription Use Per 21CFR 801.109 OR Over-The Counter (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K011961](https://fda-staging.innolitics.com/device/K011961) **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