← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K112741 # POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K112741) _Lifestyle Safty Products (Hui Zhou) Co., Ltd. · LYZ · Sep 13, 2012 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K112741 ## Device Facts - **Applicant:** Lifestyle Safty Products (Hui Zhou) Co., Ltd. - **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md) - **Decision Date:** Sep 13, 2012 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or fonger to prevent contamination between patient and examiner. It is sold as non sterile. ## Device Story Powder-free vinyl patient examination gloves; disposable; non-sterile. Worn on examiner's hand or finger during medical examinations. Function: physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Benefit: reduces risk of infection transmission during patient contact. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including physical property testing, water leak tests for pinholes (ASTM D5151-06), powder residual testing (ASTM D6124-01), and biocompatibility (dermal irritation and sensitization). ## Technological Characteristics Material: Polyvinyl Chloride (PVC). Form factor: Disposable gloves, sizes S, M, L, XL. Standards: ASTM D5250-06e1 (physical properties/dimensions), ASTM D5151-06 (pinholes), ASTM D6124-01 (powder residual). Non-sterile. Standalone 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. ## Predicate Devices - Powder-Free Non-Sterile Vinyl Examination Glove ([K100978](/device/K100978.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}------------------------------------------------ SEP 13 2012 # 510 (K) Summary (21 CFR 807.92) 510(K) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92. (applicant leave blank) The assigned 510(K) number is: Premarket Notification [510(K)] Summary #### [(a)(1)] The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared: Submitter's name: Submitter's address: Phone Number: Fax Number: Name of contact person: Date the summary was prepared: Lifestyle Safety Products (Hui Zhou) Co., Ltd Daxiaotang Village, Luoyang Town, Boluo County Hui Zhou City, Guang Dong Province, 516120 China 0086-0752-6865040 0086-0752-6863392 Ms. Yew Sing Mei January 26, 2011 ## [(a)(2)] The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known Device/ Proprietary Name: (Non-Sterile) Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product code: Patient examination glove Patient examination glove 21 CFR 880.6250 Powder Free Vinyl Patient Examination Gloves, General Hospital LYZ ## [{a){3}} An identification of the legally marketed device to which your firm is claiming substantial equivalence. #### Predicate Device Information: (1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd" {1}------------------------------------------------ ## [(a){4)| A description of the device Device Description: Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06e1, except for sterility requirements. ## [{a)(5)] The summary describes the intended use of the device Device Intended Use: Powder Free Vinyl Patient Examination Gloves (Non-Sterile) 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. It is sold as non sterile. #### Comparison to Predicate Devices The Powder free Vinyl patient examination gloves (Non-Sterile) are compared with the following Predicate Devices in terms of intended use, design, material, specification, and performance. - (1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd" #### (2) The following table shows similarities and differences of use, design, and material between our device and the predicate devices. | Description | Our Device | Predicate Device (K100978) | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Indication for Use | Disposable device intended for
medical purposes that is worn on
the examiner's hand or finger to
prevent contamination between
patient and examiner | Same | | Basic Design Material | Poly Vinyl Chloride | Same | | Size | S, M, L, XL | Same | | Single Use | Yes | Yes | | Sterile | Non sterile | Non sterile | Table 5.1 Comparison of Intended Use, Design, and Material {2}------------------------------------------------ ### [(a)(6)] A summary of the technological characteristics of new device compared to the predicate device The Powder Free Vinyl Patient Examination Gloves (Non-Sterile) are summarized with the following technological · characteristics compared to ASTM or equivalent standard. | Characteristics | Our device | Predicate Device Performance | |-----------------------|----------------------------------------|------------------------------| | Dimension | Meets ASTM D 5250-06e1 | Meets ASTM D 5250-06e1 | | Physical Properties | Meets ASTM D 5250-06e1 | Meets ASTM D 5250-06e1 | | Freedom from pinholes | Meets ASTM D5151-06 | Meets 21 CFR 800.20 | | Powder Residual | Meets ASTM D5250-06e1 and D6124-01 | Meets ASTM D6124-01 | | Biocompatibility | Primary Dermal Irritation in rabbits | Passes | | | Dermal Sensitization in the guinea pig | Passes | ## [{b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence. Powder Free Vinyl Patient Examination Gloves (Non-Sterile), meet the requirements per ASTM D5250-06e1, per ASTM D6124-01, and ASTM 5151-06. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. ## [(b)(2)] A brief discussion of the clinical submitted, reference, or replied on in the premarket notification submission for a determination of substantial equivalence. Clinical data is not needed for gloves or for most devices cleared by the 510(K) process. ## [(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than legally marketed device identified in (a)(3). 1 Based on the comparison of intended use, design, materials, and performance, it can be concluded that our vinyl disposable examination gloves powder free non-sterile, meets the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL, meet labeling claims and are substantial equivalent to its predicate devices. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Lifestyle Safety Products (Hui Zhou) Company, Limited C/O Registrar Corporation Ms. Rhonda T. Alexander Senior Regulatory Specialist Medical Device & Drug Division 144 Research Drive Hampton, Virginia 23666 SEP 13 2012 Re: K112741 Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 4, 2012 Received: September 5, 2012 Dear Ms. Alexander: 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 Federal Register. {4}------------------------------------------------ Page 2- Ms. Alexander 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/ResourcesforYou/Industry/default.htm. Sincerely yours, For Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use Applicant: Lifestyle Safety Products (Hui Zhou) Co., Ltd 510(k) Number (if known): ____N/A_ (112441 Device Name: Powder Free Vinyl Patient Examination Gloves (Non-Sterile) Indications for Use: The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or fonger to prevent contamination between patient and examiner. It is sold as non sterile. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Page _ 1 of 1 Rohit Gangulin 9/12/12 gh-Off) Anesthesiology, General Hospital Infection Control, Dental **510(k) Number:** 11.2+41 17 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K112741](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K112741) **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. 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