BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo are five black circles of varying sizes clustered together. To the right of the circles is the text "MOLNLYCKE HEALTH CARE" in all capital letters. KI12257 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SEP 2 0 2011 # Biogel® PI OrthoPro® Brown Surgical Glove This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c). | Date Prepared: | August 4, 2011 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 | | Official Correspondent: | Angela L. Bunn, RAC<br>Director, Regulatory Affairs for the Americas<br>Tel: 678-250-7930<br>Fax: 678-245-7746<br>e-mail: angela.bunn@molnlycke.com | | Trade/Proprietary Name: | Biogel® PI OrthoPro® Brown Surgical Glove | | Common Name: | Surgeon's Glove | | Classification Name: | Surgeon's Glove | | Device Class: | Class 1 | | Regulation Number: | 21 CFR 878.4460 | | Product Code: | KGO | | Predicate Device Name(s): | Poly-isoprene Non-Latex Sterile Powder-Free Surgeon's Glove<br>(K050184) | #### Description of Device: The proposed device, the Biogel® PI OrthoPro® Brown Surgical Glove is manufactured of non-latex (polyisoprene) colored with brown pigmentation. The Biogel® Pl OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years. The differences in the proposed glove and the predicate are as follows: - Addition of a Brown Colorant . - Thicker Glove . - New Former . Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side. To the right of the circles, the words "MOLNLYCKE" and "HEALTH CARE" are printed in a sans-serif font, with "MOLNLYCKE" on top of "HEALTH CARE". The glove former design used in the manufacture of this glove allows the Biogel® PI OrthoPro® Brown Surgical Glove to provide the user with this additional feature: - Slightly Curved Former with Independent/Displaced thumb ● ## Intended Use/Indication for Use: The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. ## Technological Characteristics: The Biogel® PI OrthoPro® Brown Surgical Glove is substantially equivalent to the Polyisoprene Non-Latex Sterile Powder-Free Surgeon's Glove (K050184). All of the assessed devices have similar indications for use, materials, product design, labeling claims and method of operation. The difference in the proposed device, Biogel® PI OrthoPro® Brown Surgical Glove is the thickness, a slight change to the former and the addition of the brown colorant. > Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five black circles on the left side, arranged in a triangular shape. To the right of the circles, the text "MÖLNLYCKE" is stacked above "HEALTH CARE" in a simple, sans-serif font. The overall design is clean and professional, suggesting a focus on healthcare and medical products. . ・ . . Table I -A below provides a clear detailed comparison of the proposed device (Biogel® Pl OrthoPro® Brown Surgical Glove) when compared to the predicate device. | Table 1-A | | | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence Comparison Table of Product Features | | | | Feature | Biogel® PI OrthoPro® Brown<br>Surgical Glove<br>Proposed Device | Poly-Isoprene Non-Latex Sterile<br>Powder-Free Surgeon's Glove<br>Predicate Device | | 510(k) Clearance | TBD | K050184 | | Manufacturer | Mölnlycke | Mölnlycke | | Common Name | Surgeon's Glove | Surgeon's Glove | | Classification # | Class I | Class I | | Classification<br>Name | 21 CFR 878.4460 | 21 CFR 878.4460 | | Product Code | KGO | KGO | | Indication For<br>Use/Intended Use | The Biogel® PI OrthoPro® Brown<br>Surgical Glove is a disposable<br>device made of non-latex<br>(polyisoprene) that is intended to<br>be worn on the hands, usually in a<br>surgical setting, to provide a barrier<br>against potentially infectious<br>material and other contaminants. | Poly-Isoprene non-latex sterile<br>powder-free surgeon's glove is<br>disposable device made of Poly-<br>Isoprene that is intended to be worn<br>on the hands, usually in surgical<br>settings, to provide a barrier against<br>potentially infectious material and<br>other contaminants. | | Materials | Polyisoprene | Polyisoprene | | Coated | Yes | Yes | | Powder Free | Yes | Yes | | Colored | Brown | Natural | | Sterilization<br>Method and<br>Sterility Assurance<br>Level (SAL) | Radiation<br>10-6 SAL | Radiation<br>10-6 SAL | | Biocompatibility | Materials have been assessed based<br>to ISO 10993 | Materials have been assessed based<br>to ISO 10993 | Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles on the left side of the image. To the right of the circles, the words "MÖLNLYCKE" and "HEALTH CARE" are stacked on top of each other. # Performance Testing: | Test | Result | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Skin Irritation | Gloves are non-irritating. | | ISO Closed Patch Sensitization | Gloves do not display any potential for sensitization. | | Dimensions | Gloves meet requirements of ASTM D3577. | | Physical Properties | Gloves meet requirements for rubber surgical gloves<br>per ASTM D3577. | | Freedom from Holes | Gloves exceed the requirements of 21 CFR 800.20 and<br>ASTM D3577. | | Powder Residual | Gloves meet powder level requirements for "Powder-<br>Free" designation per ASTM D3577 testing using<br>ASTM standard D6142, Standard Test Method for<br>Residual Powder on Medical Gloves. Results generated<br>values below 2mg of residual powder per glove. | # Clinical Testing: No clinical data was required. - #### Conclusion: The Biogel® PI OrthoPro® Brown Surgical Glove met the technological and performance characteristics of ASTM D3577 and are substantially equivalent to predicate device indentified in this summary with respect to intended use, materials, and design. > Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, with three wavy lines emanating from the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Angela L. Bunn Director, Regulatory Affairs for the Americas Molnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092 SEP ? 0 ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Re: K112257 Trade/Device Name: Biogel® Pi OrthoPro® Brown Surgical Glove, Powder-Free, Sterile Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 25, 2011 Received: August 26, 2011 Dear Ms.Bunn: 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 ffor 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class If (Special Controls) or class III (PMA). it may be subject to 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. {5}------------------------------------------------ ## Page 2 - Ms. Bunn Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (2) CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQ/ffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Cintheny D. Oner L. D. Womack, D.D.S. Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side of the image. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in a simple, sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line. K112257 #### INDICATIONS FOR USE 510(k) Number (if known): Device Name: Biogel® PI OrthoPro® Brown Surgical Glove, Powder-Free, Sterile Indications For Use: The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabetta F. Laurie-Willen (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number: 《パススラフ Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA