PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE

{0}------------------------------------------------ 9:00 No.001 P.12 1 1 1997 510(K) Submission for Pure Advantage Powder Free Nitrile Hypoallergenic Surgio SUBMISSION DATE: May 29, 1997 ## SUMMARY OF 510(k) Submission # K971945 JUL | A. INFORMATION | | |----------------------------------------------------|---------------------------------------------------------------------| | 1. SUBMITTER'S NAME: | TILLOTSON HEALTHCARE CORPORATION | | ADDRESS: | 360 Route 101<br>Bedford, NH 03110 U.S.A. | | TELEPHONE NUMBER: | (603) 472-6600 | | CONTACT PERSON: | Edward Markovic | | DATE SUMMARY PREPARED: | May 29, 1997 | | 2. NAME OF DEVICE | | | TRADE OR PROPRIETARY NAME: | Pure Advantage Powder Free Nitrile<br>Hypoallergenic Surgical Glove | | COMMON OR USUAL NAME: | Nitrile Powder Free Surgical<br>Glove Hypoallergenic | | CLASSIFICATION NAME: | Surgeon's Glove | | 3. PREDICATE DEVICE IDENTIFICATION<br>NAME, NUMBER | 1. Pure Advantage Powder Free Nitrile<br>Surgical Glove K922116 | 4. DESCRIPTION OF DEVICE a. HOW THE DEVICE FUNCTIONS: Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movements necessary for medical treatment. The absence of natural rubber latex in the product yields no latex protein allergens. c. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS . AND PHYSICAL PROPERTIES: Nitrile rubber is known to create a superior barrior to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. No latex protein allergens and a minimum of curative agents Impart hypoallergenic properties to the glove. The leaching process romoves traces of accelerants that may be chemically Irrifating. The Powder wash process for powdered gloves is replaced by a chiorine process. The chiorination process eliminates the surface drag of the nitrile rubber, thereby ellminating the need for donning powder. Image /page/0/Picture/8 description: The image shows a black and white drawing of a circle. The circle is not completely filled in, and the right side of the circle has a thicker, darker outline. The rest of the circle is filled with a lighter shade of gray, with some small black dots scattered throughout. Section L (Page 1) (2) SUMMARY C:\MSOFFICE\EXCEL\DATA\510K\510knfax {1}------------------------------------------------ TILLOTSON HEALTHCARE ID:6034710265 510(K) SUBMISSION FOR PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE SUBMISSION DATE: May 29, 1897 ## SUMMARY OF SAFETY AND EFFECTIVENESS (cont.) - 5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL ADDRESS - This is a disposable device, intendod for medical purposes, that is worn by operating room personnel to protect a surgical wound from contamination. Hypoallergenic surgical gloves are sultable in situations where health care worker or patient allergic sonsitivity may be a factor. Powder free gloves are Intended for use in situations where powder is not desirable. ## B. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE - · The proposed product is Identical to the product, except for the following: The proposed product is labeled : "Hypoallergenic", and is sultable for situations whore a low sensitizing glove is desirable. - · It is powder free, in the same way as predicate product. ## IF SE DECISION BASED ON PERFORMANCE DATA B. - 1. DISCUSSION OF NON-CLINICAL TESTS | SPECIFICATION | PROPOSED | PREDICATE | |---------------|------------------|------------------| | | Pure Advantage | Pure Advantage | | | Powder Free | Powder Free | | | Nitrile Surgical | Nitrile Surgical | | | Hypoallergenic | | | PERFORMANCE STANDARDS | ASTM | ASTM | |-----------------------|------|------| | WATER TIGHTNESS | ASTM | ASTM | 2. DISCUSSION OF CLINICAL TESTS | SPECIFICATION | PROPOSED | PREDICATE | |---------------------------------------------------------------|----------|-----------| | SAFETY | | | | RABBIT IRRITATION | Passes | Passes | | GUINEA PIG MAXIMIZATION | Passes | Passes | | MODIFIED DRAIZE REPEAT INSULT PATCH TEST - 200 HUMAN SUBJECTS | Passes | Passes | DESCRIPTION OF SUBJECTS For the Modified Draize Repeat Insult Patch Tost, 200 human subjects were used. The criteria for inclusion in the study was: Please see Section K-1, for Experimental Design: Inclusion Criteria and Exclusion Criteria {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Edward Markovic Quality Assurance/Regulatory Manager Tillotson Healthcare Corporation 360 Route 101 ……… Bedford, New Hampshire 03110 JUL 1 4 1997 K971945 Re : Pure Advantage Powder Free Nitrile Trade Name: Hypoallergenic Surqical Sterile Gloves Requlatory Class: I Product Code: KGO Dated: May 27, 1997 Received: May 27, 1997 Dear Mr. Markovic: 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, Druq, 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulation 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 - Mr. Markovic through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. Please also be advised that FDA is examining whether the Modified Human Draize Test, as it is currently conducted on medical gloves, is a valid means of predicting the sensitization potential of latex or synthetic materials. I E FDA finds that the test is not a scientifically sound means to predict latex or synthetic materials hypersensitivity reactions in users, then hypoallergenic claims included in labeling for medical gloves may be considered misleading, and we will move to have the claim removed from labeling for all medical gloves. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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 Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(K) SUBMISSION FOR PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE SUBMISSION DATE: May 29, 1997 510(K) 971945 510(k) Number (if known): 510(k) 971945 Page 1 of 1 Device Name: Pure Advantage Powder Free Nitrile Hypoallergenic Surgical Gloves Indications For Use: The Pure Advantage Powder Free Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460). (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) | (Division Sign-Off) | | |---------------------------------------------------------------------|-----------------------------| | Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K971945 | | Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use<br> | (Optional Format 1-2-96)