ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES

{0}------------------------------------------------ JUL 13 1999 ## XIV. SUMMARY OF SAFETY AND EFFECTIVENESS Allegrance K991992 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRAFREE PLUS 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<br>Allegiance Healthcare Corporation<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 | | Telephone: | (847) 785-3337 | | Date Summary Prepared: | 7/8/99 | | Product Trade Name: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves | | Common Name: | Surgical Glove | | Classification: | Glove, Surgical | | Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves | | Description: | Ultrafree Plus Powder-Free Surgical gloves are formulated<br>using natural rubber latex and offered sterile. | | Intended Use: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are intended<br>to be worn by operating room personnel to protect a surgical wound<br>from contamination. The gloves are appropriate for use during<br>invasive and non-invasive medical procedures requiring sterility. | | Substantial Equivalence: | Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves are<br>substantially equivalent to Ultrafree Sterile Latex Powder-Free<br>Surgical Gloves in that they provide the following characteristics:<br>- intended use<br>- size, configuration, packaging<br>- made of natural rubber latex<br>- tensile strength and elongation | {1}------------------------------------------------ : . Summary of Testing: 2017 1 YU . フロフ ס / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 2 . | Test | Result | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Systemic Toxicity | Glove does not elicit any<br>toxic reactions to acute<br>application. | | Intracutaneous Reactivity | No reactivity was observed. | | Guinea Pig Maximization | Glove does not display any<br>potential for irritation. | | Ultimate Elongation<br>& Tensile Strength | Glove meets or exceeds<br>requirements for rubber<br>surgical gloves per<br>ASTM D3577-99. | | Barrier Defects | Glove exceeds requirements<br>per 21 CFR §800.20, AQL = 2.5. | | Data/Test Method | Glove meets powder level<br>requirements for "Powder Free"<br>designation using ASTM Standard<br>D6124-97-Standard test method for<br>residual powder on medical gloves,<br>Results generated values below<br>4 mg of powder residue per glove.<br>The specification limit for the amount of<br>powder residue for this product in the<br>year 1999 will be less than 4.0 mg and<br>will be reduced by 1.0 mg each year<br>until a final limit of not more than 2.0<br>mg is achieved in accordance with<br>ASTM D3577-99. | . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces, and three wavy lines below, possibly representing water or movement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 13 1999 Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road 60085 McGaw Park, Illinois K991992 Re : Ultrafree Thick Sterile Latex Powder-Free Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO Dated: June 8, 1999 Received: June 14, 1999 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 devices marketed in interstate abe beated in the env 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. {3}------------------------------------------------ Page 2 - Ms. Sethi this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as inforibed in your 510(k) premarket notification. The FDA debtired in jour ------------------------------------------------------------------------------------------------------------------------------------------------------------marketed predicate device results in a classification for your markets predications wour device to proceed to the market. If you desire specific advice for your device on our labeling requlation (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 ene orgulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). 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/dsmamain.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}------------------------------------------------ **Allegiance** Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Winois 60085-6787 847.473.1500 FAX: 847,785,2460 Page 1 of 1 Applicant: Allegiance Healthcare Corporation 510(k) Number (if known): K991992 Ultrafree Plus Sterile Latex Powder-Free Surgical Gloves Device Name: These gloves are intended for use in environments within hospitals Indications For Use: and other healthcare facilities. The gloves are appropriate for uses during invasive as well as non-invasive surgical procedures requiring sterlity. 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 (Per 21 CFR 801.109) | or | Over-The Counter Use <span style="text-decoration: underline;">X</span> | |---------------------------------------|----|-------------------------------------------------------------------------| |---------------------------------------|----|-------------------------------------------------------------------------| | (Division Sign-Off) | |---------------------------------------------------------------------| | Division of Dental, Infection Control, and General Hospital Devices | | 510(k) Number | K991992 | |---------------|---------| |---------------|---------|