ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K023139'. The characters are written in black ink on a white background. ## Dossier: latex surgeon's sterile, powdered gloves Page 4 of 28 ### SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS ||| Van Oostveen Medical B.V. 510(k): Surgeon's gloves | | 510(k) SUMMARY<br>Prepared August 2002 | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | TRADE NAME | ROMED latex surgeon's gloves, sterile, powdered | | | GENERIC NAME | Surgeon's gloves | | | CLASSIFICATION | Class I (21 CFR 878.4460) | | | SUBMITTED BY | Van Oostveen Medical B.V.<br>Herenweg 269<br>3648 CH WILNIS<br>The Netherlands | CONTACT:<br>Mrs. M.J. van Oostveen<br>Mrs. Y.A. Zwaartman<br>Tel.: 00 31 297 282101<br>Fax: 00 31 297 288316 | | PREDICATE<br>DEVICES | K014278 Brightway Gloves, India<br>K021065 Primus Gloves Private Ltd., India | | | DEVICE<br>DESCRIPTION | The ROMED surgeon's gloves are made of natural rubber, sterile and<br>powdered with USP absorbable dusting powder. E.P. content is less than<br>100 µg/gm.<br>Surgeon's gloves are in conformity with ASTM D3577-00a standard. | | | INDICATIONS FOR<br>USE | The ROMED surgeon's sterile powdered gloves is a single use disposable<br>device made of natural rubber intended to be worn by operating room<br>personnel to protect a surgical wound from contamination. | | | TESTING | Shelf life, primary skin irritation test, guinea pig maximization test, toxicity | | | SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The ROMED surgeon's sterile and powdered gloves are substantially<br>equivalent to the predicate devices in intended use and principles of<br>operation | | | CONCLUSION | Based on the information presented, Van Oostveen Medical B.V. believes<br>that the proposed surgeon's gloves meet the minimum requirements that<br>are considered acceptable for its intended use and is substantially<br>equivalent to other currently marketed gloves | | {1}------------------------------------------------ Dossier: latex surgeon's sterile, powdered gloves #### DEVICE DESCRIPTION IV The ROMED surgeon's gloves are made of natural rubber, sterile and powdered. The ROMED surgeon's gloves are powdered with absorbable dusting powder USDP corn starch as the donning lubricant. The ROMED surgeon's sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 2 2 2003 Ms. Y vonne Zwaartman Van Oostveen Medical B.V. Herenweg 269 3648 CH Wilnis Holland Re: K023139 Trade/Device Name: Romed Latex Surgical Gloves, Powdered, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 9, 2003 Received: October 14, 2003 Dear Ms. Zwaartman: 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. {3}------------------------------------------------ Page 2 -Ms. Zwaartman 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 (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Susan Ramer 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 {4}------------------------------------------------ 510(k) number (if known): _ KC23 139 [Device name: surgeon's gloves, sterile, powdered Indications for use: The ROMED surgeon sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. Patricia A. Helen Branch, IncB Division Sign-Off) ision of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K023137 (PLEASE DO NOW 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) Over-The-Counter Use (Optional Format 1-2-96)