ULTRALON POWDER FREE LATEX SURGICAL GLOVE

{0}------------------------------------------------ . ## / 97 36 99 10 510 510 (k) Summary × 97 36 99 ULTRALON* POWDER FREE LATEX SURGICAL GLOVES Page 1 of 2 | Submitter's Name: | Johnson & Johnson Medical Inc. | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 2500 Arbrook Blvd.<br>Arlington, Texas 76014 | | Submitter's Phone Number: | (817) 784-4897 | | Submitter's Fax Number: | (817) 784-5369 | | Name of Contact Person: | Margaret Marsh | | Date of Preparation: | September 26, 1997 | | Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | ULTRALON* Powder Free Latex Surgical Gloves<br>Surgical Gloves<br>Surgeon's Gloves | | Legally Marketed Device to Which<br>Equivalency is Being Claimed: | ULTRALON* Powder Free Latex Surgical Gloves as<br>described in this 510(k) notification are substantially<br>equivalent to the currently marketed NEUTRALON*<br>Brown Latex Surgical Gloves. Both are latex gloves with<br>an inner non-latex polymer lining. | | Description of the Device: | ULTRALON* Powder Free Latex Surgical Gloves meet<br>the description of Rubber Surgical Gloves as described in<br>American Society for Testing Materials (ASTM D 3577-<br>91) as Type 1 gloves compounded primarily from natural<br>rubber latex. They are unpigmented and are powder free.<br>They are packaged sterile in pairs in size 5-1/2 through<br>size 9. | {1}------------------------------------------------ ## 510(k) Summary ULTRALON* POWDER FREE LATEX SURGICAL GLOVES Page 2 of 2 | Intended Use of the Device: | ULTRALON* Powder Free Latex Surgical Gloves are<br>intended to protect the wearer from liquids such as body<br>fluids and blood, as well as to protect surgical wounds or<br>sterile fields from microbiological contamination from the<br>wearer. | | | |----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Summary of Technological<br>Characteristics Compared to the<br>Predicate Device: | The predicate and the current glove are similar in<br>technology in that they are both latex gloves with an inner<br>non-latex polymer lining. They are dissimilar in<br>pigmentation (the predicate is a brown glove), and in the<br>presence of powder (the predicate is a powdered glove). | | | | Brief Discussion of Nonclinical<br>Tests: | Testing performed per ASTM D-3577-91 and 21 CFR<br>800.20 indicates that the product meets the requirements<br>of these standards. | | | | | Primary skin irritation testing in the rabbit and delayed<br>contact sensitization testing in the guinea pig indicate no<br>irritation or sensitization. | | | | | Final product is negative for the presence of starch using<br>the USP iodine test. | | | | Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this 510(k). | | | | Conclusions Drawn for the<br>Nonclinical and Clinical Tests: | See Nonclinical Test Section above. | | | | Other Information Deemed<br>Necessary by FDA: | Not applicable | | | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 1 6 1997 Ms. Marqaret L. Marsh Senior Project Manager, Requlatory Affairs Johnson & Johnson Medical, Incorporated 2500 Arbrook Boulevard Arlington, Texas 76004-3130 Re : K973699 Trade Name: ULTRALON™ Powder Free Latex Surgical Glove Requlatory Class: I Product Code: KGO Dated: September 26, 1997 September 29, 1997 Received: Dear Ms. Marsh: 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 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 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 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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. {3}------------------------------------------------ Page 2 - Ms. Marsh 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 requlation entitled, "Misbranding by reference to premarket notification" (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.fdaygov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Johnson & Johnson Medical, Inc. 510(k) Notification ULTRALON* Powder Free Latex Surgical Gloves ## 3.0 Indications for Use Statement Applicant: Johnson & Johnson Medical, Inc. 510(k) Number (if known): _K97 3699 Device Name: ULTRALON* Powder Free Latex Surgical Gloves Indications For Use: ULTRALON* Powder Free Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer. Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | 510(k) Number | K973699 | |---------------|---------| |---------------|---------| | Prescription Use: (Per 21 CFR 801.109) | OR | Over-the-Counter Use: ✓ | |----------------------------------------|----|-------------------------| |----------------------------------------|----|-------------------------|