MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65

{0}------------------------------------------------ **Ansell** KD 13603 ANSELL HEALTHCA NOV 1 3 2001 KO 13 Colors Harsh Ave. S.E.B. Books Co., 5.50 18 Stations Massillors S.E.B. Books 15.5.50 Massillars Massillors Marsh Ave. 5.5.6.60 15.5.5.0 130.8330.883.9911.9752.6.3.5.5.5 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com ## Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) | 510(k) Summary | | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Page 1 of 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 Preparation: | October 16, 2001 | | Trade Name: | Micro-Touch® Powder Free Latex Surgical Gloves | | Common Name: | Surgical Gloves | | Classification Name: | Surgeon's Glove | | Legally Marketed Device to Which Equivalency Is Being Claimed: | Micro-Touch® Powder Free Latex Surgical Gloves, cleared for the market under 510(k) K961632, cleared July 2, 1996. | | Device Description: | Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1. | | Intended Use: | Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination. | {1}------------------------------------------------ Micro-Touch® 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 Micro-Touch® 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 Predicate Device | | | 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 | | | | Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)<br>have the 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 Micro-Touch® 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. 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: K013603 Trade/Device Name: Micro Touch ® 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 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. 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 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. Please be advised that FDA's issuance of a substantial equivalence determination does no {3}------------------------------------------------ mean that FDA has made a determination that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cocial sunates and registered to: but not limited to: registration You must confirst (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 807), laooling (21 CFR Part 820), and if 11 CFR Part 820); and if applicable, the electronic product radiation 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) premiered 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 If you desire specific ad rios 100 for in vitro diagnostic devices), please contact the and additionally 21 CF R F at 809119 118. Additionally, for questions on the promotion and Office of Confightance wee, 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 notification (210) 11 at 00797). Village - Small Manufacturers, International and the Act may be obtained from the Driver of each of each or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ NOV 1 3 2001 ## Attachment 2 Indications for Use Statement K013603 | 510(k) Number (if known) | K013603 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Micro-Touch® Powder Free Surgical Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | | Indications for Use | Micro-Touch® 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 OR Over-The-Counter Use _ Ques. Lin 'Division Sign-Off) Control of Dental, Infection Control, - General Hospital Device r . Ope Number _