NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ K994124 AUG 1 1 2000 Image /page/0/Picture/2 description: The image shows the word "MAPA" in large, bold, black letters. Below the word "MAPA" is the word "PROFESSIONAL" in smaller, bold, black letters. The letters are all capitalized and the background is white. The logo appears to be for a brand or product called "MAPA PROFESSIONAL". 1126 Industrial Parkway N. Brunswick, OH 44212. 800.537.2897. Fax: 800.537.3299 e-mail: ce@mapaglove.com. http://www.mapaglove.com Page 1 of 3 # [1] 510 (k) Summary Date Prepared: November 24, 1999 [2] Applicant. MAPA PROFESSIONAL 1126 Industrial Parkway N. Brunswick, OH 44212 Tel: 800.537.2897 Fax: 800.537.3299 e-mail: ce@mapaglove.com Contact Person: Alejandro Sánchez Carretera Saltillo-Zacatecas Entronque a General Cepeda Km. 17.5 Col. La Encantada Saltillo, Coahuila Tel: 011(5284) 17 00 30 Fax: 011(5284) 17 82 11 e-mail: asanchez@interclan.net [3] Name of Device: Trade Name: Common Name: Classification Name: NIPROTECT Powder-Free Nitrile Ambidextrous Gloves. Patient Examination Glove {1}------------------------------------------------ K994124 Image /page/1/Picture/1 description: The image shows the word "MAPA" in large, bold, black letters. Below the word "MAPA" is the word "PROFESSIONAL" in smaller, bold, black letters. The text appears to be a logo or brand name. 1126 Industrial Parkway N. Brunswick, OH 44212. 800.537.2897. Fax: 800.537.3299 e-mail: ce@mapaglove.com. http://www.mapaglove.com Page 2 of 3 ### [4] Description: Classified by FDA's general and Plastic device Panel as Class I (21 CFR 880.6250), NIPROTECT Powder-free Nitrile Ambidextrous Gloves (80LZA). Meets all requirements of ASTM D6319 Standard for Nitrile Examination gloves for medical application. - NIPROTECT Powder-free Nitrile ambidextrous gloves meets the [ર] physical requirements of ASTM Standard D6319 Standard for Nitrile Examination gloves for medical application. - િય Intended Use. NIPROTECT Powder-free Nitrile Ambidextrous gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. - NIPROTECT Powder-free Nitrile Ambidextrous gloves are sumarized [7] with the following technological characteristics compare to ASTM or equivalent standards. | Characteristics | Standard | |---------------------------|-------------------| | Dimensions | Meets ASTM D 6319 | | Physical Properties | Meets ASTM D 6319 | | Tensile Strength, minimum | Meets ASTM D 412 | | Freedom from holes | Meets ASTM D 6319 | | | Meets ASTM D 5151 | | Powder Free | Meets ASTM D 6319 | | | Meets ASTM D 6124 | Puncture EN 388 Meets {2}------------------------------------------------ K994124 Image /page/2/Picture/1 description: The image shows the logo for MAPA Professional. The word "MAPA" is in large, bold, black letters. Below it, the word "PROFESSIONAL" is in smaller, bold, black letters. 1126 Industrial Parkway N. Brunswick, OH 44212. 800.537.2897. Fax: 800.537.3299 e-mail: ce@mapaglove.com. http://www.mapaglove.com Page 2 of 3 [8] Comparison to Predicate Device and Equivalence. Non-clinical Performance Date: Applicant device conforms fully to ASTM D6319. Standards specifications for Nitrile examination gloves for medical application. It also meets all requirements of ASTM D412-Tensile, ASTM D624-Tear, EN 388-Puncture and ASTM D6124-residual powder. This device is substantially equivalent to those in commercial distribution. #### તિ) Conclusions: It is concluded that NIPROTECT Powder-Free Ambidextrous Gloves are safe, effective and substantially equivalent to those currently in commercial distribution. It conforms fully to ASTM D6319, Standard specification for nitrile examination gloves for medical application and 21 CFR170-199 food additives. - This summary will include any other information reasonable deemed [10] necessary by the FDA. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling the perimeter in bold, uppercase letters. At the center is a stylized emblem consisting of three abstract, wing-like shapes, arranged in a descending, overlapping pattern. The emblem is rendered in solid black, contrasting with the white background of the seal. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 1 2000 Mapa Professional C/O Mr. Alejandro Sanchez Quality Manager Carretera Saltillo-General Cepeda 947 Col. La Encantada Saltillo Coah MEXICO K994124 Re : Niprotect Powder-Free Nitrile Trade Name: Examination Gloves Regulatory Class: I Product Code: LZA July 6, 2000 Dated: Received: July 6, 2000 ## Dear Mr. Sanchez: 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 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). 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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations. {4}------------------------------------------------ Page 2 - Mr. Sanchez This letter will allow you to begin marketing your device as This letter will allow you ee are to trification. The FDA described in your 510(K) prematice of your device to a legally finding of substantial equivalence of your device for your finding of substancial equivarence on a classification for your marketed predicate device resures in a camat. device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling If you desire specific advice read additionally 809.10 for in regulation (21 crk Fare ove are sontact the Office of vitro diagnostic devices), please contact the for questi vitro diagnostic devices); preaso otionally, for questions on Compliance at (301) 334 - 1222 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - - 13 - - - 13 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - the promotion and advertising of your ac-rosy from the office of the Office of "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general premarket notification - (arch over the Act may be information on your responsible small Manufacturers Assistance obtained from the Division of Billian Halling (301) 443-6597 or at its internet address lts incernet addrebb "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Patrice Cucentaffa Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Mapa Professional. The word "MAPA" is written in large, bold, black letters. Below it, the word "PROFESSIONAL" is written in smaller, black letters. The font is sans-serif and slightly slanted. 1126 Industrial Parkway N. Brunswick, OH 44212. 800.537.2897. Fax: 800.537.3299 isthal Parkway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Indications for Use Statement. 4.0 # INDICATIONS FOR USE K994124 Applicant: MAPA PROFESSIONAL - 510 (k) Number (if know):* Device Name: NIPROTECT - Powder free Nitrile Examination Gloves Indications For Use: A patient examination glove is a disposable device intended for medical A pattent exammation grove is a examiner's hand or finger to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH Office of Device evaluation (ODE) Chiu S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devig 1-10(k) Number _ Prescription Use Over the Counter Use OR