TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O

{0}------------------------------------------------ Abbreviated 510(k) Premarket Notification Latex Sterile Powder Free Examination Gloves Section 5, 510(k) Summary Page 1 of 3 | 5. | 510(k) SUMMARY | | | K122788 | |-------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------| | DATE: | | February 17, 2012 | | | | OWNER: | | Northstar Healthcare Holdings<br>70 Sir John Rogerson's Quay<br>Dublin 2, Ireland | | JAN 17 2013 | | OFFICIAL CORRESPONDENT: | | Michael Riordan<br>Operations Manager<br>Telephone: 00353-21-4548255<br>Fax: 00353-21-4548294<br>Email: michael.riordan@mckesson.ie | | | | DEVICE NAME: | | Trade Name: | Textured, White, Latex, Sterile Powder Free<br>Examination Gloves with Protein labeling Claim<br>(50µg/dm² or Less of Water Soluble Protein) | | | | | Common Name: | Patient Examination Gloves | | | | | Classification: | Patient Examination Gloves | | | | | Class: | Class I | | | | | Product Code: | LYY | | ## PREDICATE DEVICE(S): | Predicate<br>510(k) | Device Name | Indication | Clearance<br>Date | Company | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------| | K090327 | Powder Free Polymer<br>Coated Latex<br>Examination Gloves,<br>Sterile, with Protein<br>labeling Claim<br>(50 $ μ $ g/dm² or Less of<br>Water Soluble Protein) | A powder free polymer coated latex<br>examination glove is a disposable device<br>made of natural rubber material intended to<br>be worn on the hand for medical purposes to<br>provide barrier against potentially infectious<br>materials and other contaminants. | 03 Apr 2009 | Wear Safe SDN,<br>BHD | DEVICE DESCRIPTION: Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50μg/dm² or Less of Water Soluble Protein) {1}------------------------------------------------ ## STATEMENT OF INTENDED USE: The Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50ug/dm² or Less of Water Soluble Protein) is a Disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. ## TECHNOLOGICAL CHARACTERISTICS: The Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes. | Feature | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) K090327 Predicate | Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) (Proposed) | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Same | | Indications for Use Statement | A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. | The sterile latex 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. | | Description | Sterile, powder free, examination gloves made of latex. The gloves are provided in sizes small, medium, and large. | Same | | Presentation | Sterile gloves are provided in dispenser boxes. | Same | | Color | White | White | | Material | Latex | Same | | Sterilization | Sterile | Same | | Single Use | Yes | Same | | Dimensions | Meets ASTM D3578-05 | Length Small 220mm min.<br>Medium, Large 230 mm min.<br>Width Small 80-90mm<br>Medium 90-100mm<br>Large 101-111mm<br>Thickness Finger 0.13 mm min.<br>Palm 0.11 mm min. | | Physical Properties | Meets ASTM D3578-05 | Before aging/after aging<br>Elongation 650% 500%<br>Tensile Strength 18MPa 14MPa | | Freedom from Pinholes | Meets ASTM D5151-06 | Same | | Residual Powder | Meets ASTM D6124-06 | Same | | Protein Level | Meets ASTM D5712-10 | Same | {2}------------------------------------------------ | Biocompatibility<br>Tests | Passes Primary Skin Irritation in Rabbits<br>Passes Guinea Pig Maximization | Same<br>Same | |---------------------------|-----------------------------------------------------------------------------|--------------| | Sterilization | Radiation dose of 25 kGy. | Same | # ASSESSMENT OF NONCLINICAL DATA: | Characteristic | Standard | Device<br>Performance | |-------------------------------------------------------------|------------------------------|-------------------------------------------------------------------------| | Dimension | ASTM Standard D3578 | Meets | | Physical Properties | ASTM Standard D3578 | Meets | | Freedom from Pinholes | 21 CFR 800.20; ASTM<br>D5151 | Meets | | Powder Residual | ASTM Standard D6124 | Meets<br>Results generated<br>values below 2mg<br>of residual<br>powder | | Protein Level | ASTM Standard D5712 | Meets<br>Results generated<br>values below 50<br>mcg/gm | | | Biocompatibility | Primary Skin Irritation<br>in rabbits<br>(ISO 10993-10) | | Dermal Sensitization in<br>the guinea pig (ISO<br>10993-10) | | Gloves do not<br>display any<br>potential for<br>sensitization | ## CONCLUSIONS: The Latex Sterile Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10. Based on the comparison of intended use, design, materials and performance, the Latex Sterile Powder Free Examination Gloves are substantially equivalent to the predicate device. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol to the right and text arranged in a circular fashion to the left. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". ## January 17, 2013 Northstar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, IL 60062 Re: K122788 Trade/Device Name: Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein Labeling Claim (50ug/dm2 or Less of Water Soluble Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 27, 2012 Received: January 4, 2013 Dear Mr. Devine: 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 - Mr. Devine 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. Clinton D. Annett Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE #### 510(k) Number (if known): K122788 Device Name: #### Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein) Indications for Usc: The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. AND/OR Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ੱਤੀ ﺗﺸﻬﺪ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF needed) Concur valuation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 188 510(k) Number: Page Tot 1