BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

{0}------------------------------------------------ K071414 ## 510(k) SUMMARY - Applicant: 1. - 2. Contact Person: - 3. Device Name: Common Name: Classification: - 4. Predicate Device : - 5. Device Description: - 6. Intended Use of the Device: - 7. Technological Characteristics of the Device: Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility Primary Skin Irritation Guinea Pig Sensitization LALTest-(final endotoxin concentration) - 8. Performance Data - ு. Clinical Data - 10. Conclusion: Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 Norcross, GA 30092 SEP 1 0 2007 Steven Dowdley, RAC Director of Regulatory Affairs Tel.: 678-250-7930 Fax: 678-250-7979 Biogel Eclipse Indicator Underglove with non-pyrogen statement Surgical Glove (CFR 878.4461) Class | K062847 - Biogel Eclipse Latex, Sterile, Powder Free, Indicator Underglove The Biogel Eclipse Indicator Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram. The Biogel Eclipse Indicator Underglove 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. The Biogel Eclipse Indicator Underglove characteristics are summarized below as compared to ASTM requirements and to the predicate devices. Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577 Pass Pass <0.25EU/ml The performance data are summarized above. No clinical data was required. The Biogel Eclipse Indicator Underglove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate device identified in sited in this 510(k) summary. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 2007 SEP 10 2007 Mr. Steven Dowdley, RAC Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092 Re: K071414 Trade/Device Name: Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling Claim (50 micrograms or less) and with Non-Pyrogenic Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 26, 2007 Received: August 28, 2007 Dear Mr. Dowdley: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {2}------------------------------------------------ ## Page 2 - Mr. Dowdley 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); 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chin Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for "HOLYOKE HEALTHCARE". The logo consists of a cluster of circles on the left side and the text "HOLYOKE" on the top line and "HEALTHCARE" on the bottom line on the right side. The text is in a simple, sans-serif font. ## 3.0 Indications for Use Statement: | Applicant: | Molnlycke Heath Care US, LLC | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K071414 | | Device Name: | Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein<br>Content Labeling Claim (50 micrograms or less) and with Non-Pyrogenic<br>Claim | ## Indication for Use: The Biogel Eclipse Indicator Underglove 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. (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) | Prescription Use | | |---------------------|---| | Or Over-The-Counter | x | | Per 21 CFR 801.109 | | Shade H. Murphy, M.D. (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 710(k) Number: K171414