ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES

{0}------------------------------------------------ K983962 8 1999 JAN ! 上 ## XIV. SUMMARY OF SAFETY AND EFFECTIVENESS Allegiance ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES | Manufacturer: | Allegiance Healthcare Sdn. Bhd.<br>Plot 87, Kampung Jawa<br>11900 Bayan Lepas<br>Penang, West Malaysia | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation<br>1500 Waukegan Road, Bldg. K<br>McGaw Park, IL 60085 | | Telephone: | (847) 785-3337 | | Date Summary Prepared: | October 21, 1998 | | Product Trade Name: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves | | Common Name: | Surgical Glove | | Classification: | Glove, Surgeon's | | Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves | | Description: | The Ultrafree Textured Surgical gloves are formulated using<br>natural rubber latex and offered powder-free and sterile. | | Intended Use: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves are<br>intended for use in environments within hospitals and other<br>healthcare facilities. The gloves are appropriate for use during<br>invasive and non-invasive medical procedures requiring sterility.<br>They are intended to be worn by operating room personnel to<br>protect a surgical wound from contamination. | | Substantial Equivalence: | The Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves<br>are substantially equivalent to Ultrafree Sterile Latex Powder-Free<br>Surgical Gloves in that they provide the following characteristics:<br>- same intended use<br>- same sizes, configuration, packaging<br>- both made of natural rubber latex<br>- same tensile strength and thickness profiles | | Summary of Testing: | | | Test | Result | | Primary Skin<br>Irritation | Biocompatability tests successfully performed on Ultrafree Surgical<br>Gloves were considered applicable to Ultrafree Textured Surgical<br>Glove since they are made using the same latex formulation and<br>manufacturing process. Gloves do not display any potential for<br>irritation. | | Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. | | Intracutaneous Reactivity | Gloves show no reactivity. | | Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. | | Guinea Pig Maximization | Gloves do not display any potential for irritation. | | Ultimate Elongation<br>& Tensile Strength | Gloves meet or exceed requirements for rubber surgical gloves<br>per ASTM D3577-91. | | Barrier Defects | Gloves meet or exceed requirements per 21 CFR<br>§800.20, AQL = 2.5. | | Data/Test Method | Gloves meet powder level requirements for "Powder Free"<br>designation using ASTM Standard D6124-97-Standard test method<br>for residual powder on medical gloves. Results generated values<br>below 2 mg of residual powder per glove. | {1}------------------------------------------------ ## K983962 Page 2 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element on the left. The graphic consists of three curved lines or shapes stacked vertically, resembling a simplified representation of a wing or a flowing object. To the right of the graphic, there is a partial word or name, with only the letters 'DEPART' visible. The overall impression is that of an official or organizational symbol, possibly related to a department or agency. 1000 JAN Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Building K McGaw Park, Illinois 60085 Re: K983962 Ultrafree Textured Sterile Latex Powder-Free Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO Dated: December 16, 1998 December 17, 1998 Received: Dear Ms. Sethi: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {3}------------------------------------------------ Page 2 - Ms. Sethi through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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) 594-4692. 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 genera Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmanain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is written in a bold, sans-serif font, with the letters slightly slanted to the right. The overall impression is one of strength and stability. .............................................................................................................................................................................. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460 Page 1 of 1 | Applicant: | Allegiance Healthcare Corporation | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K983962 | | Device Name: | Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves | | Indications For Use: | These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. | ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |------------------------------------------|--------------------------------------------------------| | Prescription Use<br>(Per 21 CFR 801.109) | or | | | Over The Counter Use | | | (Division Sign-Off) | | | Division of Dental, Infection Control | Division of Dental, Infection, Et and General Hospital Device: 510(k) Number K983662