THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR

{0}------------------------------------------------ Jan 3 1 2000 K993857 . . Attachment 4 ## 510(k) Summary Summary Attached Signature James R. Chatterton Typed Name November 12, 1999 Date {1}------------------------------------------------ K99 3857 The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax: - [1] Summary - [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 | Contact: | James R. Chatterton | |------------|---------------------| | Telephone: | 330-833-2811 | | Fax: | 330-833-6213 | November 12, 1999 - [3] Trade Name: The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Common Name: Surgical Gloves Classification Name: Surgeon's Glove - [4] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1. - [5] The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves. - The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable [e] devices intended to be worn by operating room personnel to protect a surgical wound from contamination. - The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are summarized with [7] the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standard | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimensions | Meets ASTM D 3577-99 | | Physical Properties | Meets ASTM D 3577-99, Type 1 | | Freedom from holes | Meets ASTM D 3577-99<br>Meets ASTM D 5151-92 | | Protein Label Claim | This latex glove contains 60 micrograms or<br>less of total water extractable protein per<br>gram.<br>Meets ASTM D 5712-95 Standard Test<br>Method for Analysis of Protein in Natural<br>Rubber and Its Products | | Biocompatability | | Primary Skin Irritation in Rabbits Guinea Pig Sensitization Passes Passes {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "KG93857". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having unique shapes. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax: - The performance test data of the non clinical tests are the same as mentioned immediately above. [8] - Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. വി - It is concluded that The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) [10] are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product. - [11] This summary will include any other information reasonably deemed necessary by the FDA. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 31 2000 Mr. James R. Chatterton Vice President Regulatory Ansell Perry Ansell Healthcare Products, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646 Re : K993857 Trade Name: The Original Perry, Style 42 White Latex Powdered Surqical Gloves With Protein Content Labeling Claim (60 micrograms or less) Regulatory Class: I Product Code: KGO Dated: November 12, 1999 November 15, 1999 Received: Dear Mr. Chatterton: 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in {4}------------------------------------------------ Page 2 - Mr. Chatterton the Federal Register. Please note: this response to your premarket notification submission does not affect any premarker nocurright have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as fire ited in your 510 k) premarket notification. The FDA debtired in form of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production permits your device to proceed to the market. If you desire specific advice for your device on our labeling II you debire bpoort 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Journal Manufacturers Assistance obeation 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 Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Attachment 2 ### Indications for Use Statement | 510(k) Number (if known) | K993857<br>None, preamendments device | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | The Original Perry Style 42<br>White latex powdered surgical gloves with Protein Content Labeling Claim<br>(60 micrograms or Less) | | Indications for Use | The Original Perry Style 42 Surgeon's Glove intended use is to be worn by<br>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 : 中国 上海 出している。 OR Over-The-Counter Use \$\longrightarrow\$ Qiu S. Lin (Division Sign-Off) Division of Dental, Infectio and General Hospita 510(k) Number _ 10