BIOGEL ORTHOPOR BROWN SURGICAL GLOVE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles of varying sizes on the left side. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in black, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line. # MARY OF SAFETY AND EFFECTIVENESS | Biogel® OrthoPro® Brown Surgical Glove | | |--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | This 510(k) summary of safety and effectiveness information is being submitted in<br>accordance with the requirements of 21 CFR 807.92(c). | | | Date Prepared: | July 20, 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® 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): | Biogel® Sensor Surgeons Glove (K071700)<br>Biogel® Orthopedic Surgical Glove (K071465) | ## Description of Device: The proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Dieself on and Cate natured one, Inc. Diogel Ortholfrom pigmentation. The Bioget® Orthological of the Brown natured Glove is manufactured of the exact same metarial Surging which colored of the exact same material and coated with the Biogel® Brown of Brown of Brown of Brown of Brown of Brown of Brown of - 1 - 2019 15 manuacuted of the exact same material and coated with the Bioght Coating which is used on the currently cleared device(s) that have been legally marketed by Mology and in ased on the currently cleared device(s) that have been legally for The closes for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® and good onliner design used in the manufacture of this glove allows Brown Surgical Glove to provide the user with this additional feature: - Slightly Curved Former with Independent/Displaced thumb . {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles of varying sizes arranged in a cluster on the left side. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is displayed in a simple, sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line. # Intended Use/Indication for Use: The Bioge!® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical catting at wor 1 a 1 - 2011 - Officil 10 - Brown Surgical Glove is a disposalsetting, to annural n latex that is intended to be worn on the hands, usually in a surgical setting, to provide the world is intonded to be worn on the hands, usually in a surgicol seen barrier against potentially infectious material and other contaminants. # Technological Characteristics: The Biogel® OrthoPro® Brown Surgical Glove is substantially equivalent to the Biogel® Sensor Surgeons Glove (K071700) and Biogel® Orthopedic Surgical Change States of States - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 (100 ourgons Clove (1071700) and Biogel® Orthopedic Surgical Glove (K071465). All Allere (K071465). of the assessed devices have similar indications for use, materials, pr claims and method of operation. The difference in the proposed device, Biogel® OrthoPro® Brown Surgical Glove is the l thickness, a slight change to the former and the addition of the broun ask the caller one in the proposed device, Biogel® OrthoPro® Brown Surgical Glor 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 Tel 678 250 7900 Fax 678 250 7994 www.molnlycke.com {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles clustered together on the left side. To the right of the circles is the text "MÖLNLYCKE" in all caps on the first line and "HEALTH CARE" in all caps on the second line. Table 1-A below provides a clear detailed comparison of the proposed device (Biogel® OrthoPro® Brown Surgical Glove) when compared to the predicate devices. | Feature | Biogel® OrthoPro®<br>Brown<br>Surgical Glove<br>Proposed Device | Biogel® Sensor<br>Surgeons Glove<br>Predicate Device | Biogel® Orthopedic<br>Surgical Glove<br>Predicate Device | |-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Clearance | TBD | K071700 | K071465 | | Manufacturer | Mölnlycke | Mölnlycke | Mölnlycke | | Common Name | Surgeon's Glove | Surgeon's Glove | Surgeon's Glove | | Classification # | Class I | Class I | Class I | | Classification<br>Name | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | | Product Code | KGO | KGO | KGO | | Indication For<br>Use/Intended Use | The Biogel®<br>OrthoPro® Brown<br>Surgical Glove is a<br>disposable device<br>made of natural<br>rubber latex that is<br>intended to be worn<br>on the hands, usually<br>in a surgical setting,<br>to provide a barrier<br>against potentially<br>infectious material<br>and other<br>contaminants. | The Biogel® Sensor<br>Surgeons Glove<br>(K071700) is a<br>disposable device<br>made of natural<br>rubber latex that is<br>intended to be worn<br>on the hands, usually<br>in a surgical setting,<br>to provide a barrier<br>against potentially<br>infectious material<br>and other<br>contaminants. | The Biogel®<br>Orthopedic Surgical<br>Glove (K071465) is a<br>disposable device<br>made of natural<br>rubber latex that is<br>intended to be worn<br>on the hands, usually<br>in a surgical setting,<br>to provide a barrier<br>against potentially<br>infectious material<br>and other<br>contaminants. | | Materials<br>Coated | Latex | Latex | Latex | | Powder Free | Yes | Yes | Yes | | Colored | Brown | Yes | Yes | | Sterilization<br>Method and<br>Sterility Assurance<br>Level (SAL) | Radiation<br>10-6 SAL | Natural<br>Radiation<br>10-6 SAL | Natural<br>Radiation<br>10-6 SAL | | Biocompatibility | Materials have been<br>assessed based to<br>ISO 10993 | Materials have been<br>assessed based to<br>ISO 10993 | Materials have been<br>assessed based to<br>ISO 10993 | Mölnlycke Health Care 5550 D-5550 Peachtree Parkway, Suite 500 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 UC A Book Cochiree Parkway. Norcross, GA 30092 USA · {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Mölnlycke Health Care. The logo consists of five black circles of varying sizes arranged in a cluster on the left. To the right of the circles, the words "MÖLNLYCKE" and "HEALTH CARE" are stacked on top of each other. The text is in a simple, sans-serif font. ## Performance Testing: Test ### Result Primary Skin Irritation ISO Closed Patch Sensitization Dimensions Physical Properties Freedom from Holes Protein Extractables Powder Residual Gloves are non-irritating. Gloves do not display any potential for sensitization. Gloves meet requirements of ASTM D3577. Gloves meet requirements for rubber surgical gloves per ASTM D3577 per ASTM D3577. Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577. Gloves meet requirements of ASTM D5712. Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577 testing using ASTM standard D6142, Standard Test Method for Residual Powder on Medical Gloves. Results generated values below 2mg of residual powder per glove. ### Clinical Testing: No clinical data was required. #### Conclusion: The Biogel® OrthoPro® Brown Surgical Glove met the technological and performance in characteristics of ASTM D3577 and are substantially equivalent to predicate devices characteristics of ASTM D3577 and are substantially equivalent to predicate devices indentified in this summary with respect to intended use, materials, and design, > Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA Tei 678 250 7900 Fax 678 250 7984 www.molnlycke.com {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Angela L. Bunn, RAC Director, Regulatory Affairs for the Americas Molnlycke Healthcare, US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092 AUG 2 4 2011 Re: K112089 Trade/Device Name: Biogel® OrthoPro® Brown Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 9, 2011 Received: August 10, 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 (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. 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 II (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 Eederal 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) (21 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. If 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/CDRHOffices /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/ReportaProblem/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. Anthony, V, Water Anthony D. Watson, B.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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of five circles on the left side, resembling cells or molecules. To the right of the circles, the text "MÖLNLYCKE HEALTHCARE" is displayed in a simple, sans-serif font. The overall design is clean and professional, conveying a sense of scientific expertise and healthcare focus. K11 2089 #### INDICATIONS FOR USE 510(k) Number (if known): ____________ K112089 Device Name: Biogel® OrthoPro® Brown Surgical Glove with ≤50μg/g total water extinctable protein statement, Powder-Free, Sterile Reorder Code -- 32160, 32165, 32170, 32175, 32180, 32185, and 32190 Indications For Use: The Bioge!® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex 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) Concurrence of CERH, et al. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K112059 Page I of Mölnlycke Health Care 5550 Peachtree Parkiray, Suite 500 Norcross, GA 30092 USA Tol 228 250 7900 Fax 338 250-7964 Page 74 of 941; 40.00m