MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES

{0}------------------------------------------------ **Ansell** K013604 ANSELL HEALTHCARE PRODUCTS INC. 1875 Harsh Ave. S.E. • P.O. Box 550 Marsh Ave. S.E. • P.O. Box 550 330.833.2811 / Bood8-05550 L.S.A. 187.8833.2811 / Boo.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com # NOV 1 3 2001 #### Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) | [1] | <b>510(k) Summary</b><br>Page 1 of 2 | | |-----|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | [2] | Submitter: | Ansell Healthcare Products Inc. Inc.<br>1875 Harsh Avenue SE<br>Massillon, Ohio 44646 | | | Contact: | James R. Chatterton | | | Telephone: | 330-833-2811 x297 | | | Fax: | 330-833-6501 | | | Date of<br>Preparation: | October 16, 2001 | | [3] | Trade Name: | Ultralon® Powder Free Latex Surgical Gloves | | | Common Name: | Surgical Gloves | | | Classification<br>Name: | Surgeon's Glove | | [4] | Legally Marketed<br>Device to Which<br>Equivalency Is<br>Being Claimed: | Ultralon® Powder Free Latex Surgical Gloves, cleared for the market under<br>510(k) K973699, December 16, 1997 | | [5] | Device<br>Description: | Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all<br>the current specifications for ASTM D 3577-00, Rubber Surgical Gloves,<br>Type 1. | | [6] | Intended Use: | Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) are<br>sterile disposable devices intended to be worn by operating room personnel<br>to protect surgical wounds from contamination. | {1}------------------------------------------------ K013604 Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6501 Fax: Page 2 of 2 Predicate Device - Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) are [7] Summary of equivalent to the predicate device in that they have the same following Technological Characteristics technological characteristics. Compared to | | | Characteristic | Standard | |------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | | | Dimensions | Meets ASTM D 3577-00 | | | | Physical Properties | Meets ASTM D 3577-00 | | | | Freedom from holes | Meets ASTM D 3577-00 | | | | | Meets ASTM D 5151-99 | | | | Biocompatability | Passes Primary Skin Irritation in<br>Rabbits Test | | | | | Passes Guinea Pig Sensitization<br>Test | | | | Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) have the<br>additional characteristic: | | | | | Protein Label Claim: This latex glove<br>contains 50 micrograms or less of<br>total water extractable protein per<br>gram | Meets ASTM D 5712-99 Standard<br>Test Method for Analysis of Protein<br>in Natural Rubber and Its Products | | [8] | Brief Discussion of<br>Non-clinical Tests | Non-clinical test data (see [7] above) indicate that the product meets all<br>applicable ASTM standards, and FDA requirements for biocompatibility and<br>protein label claim. | | | [9] | Clinical Tests: | Clinical data are not needed for medical gloves or for most devices cleared<br>by the 510(k) process. | | | [10] | Conclusions<br>Drawn from Non-<br>clinical Tests: | It is concluded that the Ultralon® Powder Free Latex Surgical Gloves<br>(Protein Label Claim) are as safe and effective, and perform as well as the<br>predicate product. They meet ASTM listed standards, and FDA<br>requirements for holes and protein labeling claims. | | | [11] | Other Information<br>Deemed<br>Necessary by FDA | This summary will include any other information reasonably deemed<br>necessary by the FDA. | | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 3 2001 Mr. James R. Chatterton Vice President Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, SE Massillon, Ohio 44646 Re: K013604 Trade/Device Name: Ultralon ® Powder Free Latex Surgical Gloves with Protein Content Labeling Claim ( 50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove, Powder-Free Regulatory Class: I Product Code: KGO Dated: October 15, 2001 Received: October 31, 2001 Dear Mr. Chatterton: We have reviewed your Section 510(k) premarket notification of intent to market the device we mave 10110wed your and have determined the device is substantially equivalent (for the ications 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 mendments, 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 the I cuclar I vou, Drug, the Comment , therefore, market the device, subject to the general approvisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 NET), It hay of easy of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of roublish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not {3}------------------------------------------------ mean that FDA has made a determination that your device complies with other requirements modi that I Drima mass statutes and regulations administered by other Federal agencies. of the Act of ary I oueral states requirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CF reviews) availty systems (QS) regulation (21 CFR Part 820); and if requirents as set form in als quality in control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(K) premium not nourication evice 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 II you desire specific ad 1100 100 for in vitro diagnostic devices), please contact the alle additionally 21 CF FC rc at 609116 118. Additionally, for questions on the promotion and Office of Collighance wice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may be occasion at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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}------------------------------------------------ ### Attachment 2 ## Indications for Use Statement NOV 1 3 2001 | 510(k) Number (if known) | K013604 | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Ultralon® Powder Free Surgical Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | | Indications for Use | Ultralon® Powder Free Latex Surgical Gloves are 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 IF NEEDED ## Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Division Sign-Off) Division of Dental, Infection Control, and General Hospital, D 510(k) Number Page 18 of 31