← Product Code [LZA](/productcode/LZA) · K111718 # LANO-E (K111718) _Ug Global Resources Sdn. Bhd. · LZA · Jun 8, 2012 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K111718 ## Device Facts - **Applicant:** Ug Global Resources Sdn. Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Jun 8, 2012 - **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 hand or finger to prevent contamination between the patient and the examiner. ## Device Story Disposable nitrile examination glove; blue color; features inner coating of lanolin and vitamin E. Worn by healthcare professionals during patient examinations to provide barrier protection against contamination. Device is non-sterile and powder-free. Available in sizes XS through XL. Packaged in dispenser boxes. Functions as a physical barrier; performance verified through water-tight testing and physical property assessments per ASTM standards. ## Clinical Evidence Bench testing only. No clinical data. Evidence includes biocompatibility testing (dermal sensitization and primary skin irritation per ISO 10993-10:2002), physical property testing (ASTM D6319-10), powder-free residue testing (ASTM D6124-06), and 1000ml water-tight testing (ASTM D5151-06). ## Technological Characteristics Material: Nitrile. Cuff: Beaded. Powder residue: Max 2mg/glove. Standards: ASTM D6319-10 (dimensions, physical properties, pinholes, powder residue), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residue). Biocompatibility: ISO 10993-10:2002. Coating: Lanolin and Vitamin E. Sizes: XS-XL. ## 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 - [K050765](/device/K050765.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}------------------------------------------------ ### SUMMARY ### PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue K III 718 JUN - 8 2012 Submission Applicant: UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Negeri Sembilan Darul Khusus, Malaysia Official Correspondent: Kenneth J. Stanton,President UG Healthcare (USA) Inc. 1565 Sunflower Avnue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271 Description of the Device: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue Trade Name: Lano-E #### Common Name: Examination Gloves A. Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Nitrile examination glove 80LZA that meets all of the requirements of ASTM D6319-10. Lano-e Nitrile Powder-Free Examination Gloves, Predicative Devices: #K050765. Intended Use of the Device: A 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 the patient and the examiner. Page - 9 {1}------------------------------------------------ ## SUMMARY #### PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue #### Summary of Technological Characteristics: Material: Nitrile Cuff: Beaded Powder Residue: Maximum 2mg/glove | Characteristics | Standards | Device Performance | |-----------------------|---------------------------------------------------|-------------------------------| | Dimensions | ASTM D 6319-10 | Meets | | Physical Properties | ASTM D 6319-10 | Meets | | Freedom from Pinholes | ASTM D 6319-10 | Meets | | | ASTM D 5151-06 | Meets | | Powder-Free Residue | ASTM D 6319-10 | Meets | | | ASTM D 6124-06 | Meets | | Biocompatibility | Dermal Sensitization
(as per ISO 10993-10:2002 | Not a contact skin sensitizer | | | Primary Skin Irritation Test | Not a primary skin irritant | #### Special Properties: Lanolin and Vitamin E inner coating Packaging: 100 pcs per dispenser box, 10 boxes per case, 1.000 gloves per case #### Sizes: XS — XL Conclusion: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue, meets the physical property requirements of ASTM D 6319-10, the FDA 1000ml water test both before and after aging. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K050765. It has been supported by results of Biocompatibility Tests. Residual . Powder Contents tests, Physical Property Tests and the 1000ml Water Tight Test. | Summary Preparation Date | June 7, 2012 | |--------------------------|--------------| |--------------------------|--------------| Page - 10 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 UG Global Resources SDN BHD c/o Mr. Kenneth Stanton President UG Healthcare (USA), Incorporated 1565 Sunflower Avenue Costa Mesa, California 92626 8 2012 Re: K111718 Trade/Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 23, 2012 Received: May 29, 2012 Dear Mr. Stanton: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register. {3}------------------------------------------------ #### Page 2- Mr. Stanton 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. For Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Anthony D. Watson, B.S., M.S., M.S., M.B.A. Enclosure {4}------------------------------------------------ Indications for Use: 510K K111718 # Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin ation Courter - Seconder and Vitamin E Coating, Blue and Vitamin E Coating, Blue lndications for Use – Non-Sterile, Powder-Free, Nitrile Examination Gloves with . Lanolin and Vitamin E Coating, Blue is a disposable device intended for Medical Purposes that is worn on the exercity of the server with finger to prevent contamination between patient and examiner finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (Part 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) Elizabeth F. Clavine-Williams (Division Sign-Off) Civision of Anesthesiology, General Hospital · Rection Control, Dental Devices 510(k) Number: --- **Source:** [https://fda-staging.innolitics.com/device/K111718](https://fda-staging.innolitics.com/device/K111718) **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