MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

{0}------------------------------------------------ ## APR 1 3 2005 ## Section E - 1 - 510(k) Summary Medigloves Ltd. Submitters Name : Submitter's Address : 33/3 Moo 2 Tivanont Road Amphur Muang Pathumtani 12000 Thailand Submitter's Phone Number : +662 501 2141-5 Submitter's Fax Number : +662 501 2146-7 Name of Contact Person : Mr. Worasak Wongprakornkul Date of Preparation : January 19, 2005 Trade Name of Device : Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves Device Name : Medigloves® Sterile Green Powder-free Synthetic Polyisoprene Surgical Gloves (Green) Common Name : Surgical Gloves Classification Name : Surgeon's gloves, powder-free (per proposed § 878.4461) Legally Marketed Device to Which Equivalency is Being Claimed : Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves as described in this 510(k) notification are substantially equivalent to: ESTEEM® Sterile Polyisoprene Surgical Gloves (K011721) Sterile SensiCare™ Synthetic Polyisoprene Powder-Free Surgical Gloves (K002933) BarrierPlus® Powder-Free Synthetic Polyisoprene Surgical Gloves (K990710) The difference is that Medigloves' gloves has green color but the safety and effectiveness of the device is maintained. #### Description of the Device: The gloves are made of polyisoprene synthetic latex and green colored. They are washed with Ammonia solution to leach off mold release powder, chemical and protein before they are chlorinated and inner coated with the solution of coating material for ease of donning. The gloves are tested for pinhole by water leak test machine. They are sterilized by gamma irradiation. Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves meet the description of Rubber Surgical Gloves as described in ASTM D 3577-01a24, type 2 rubber surgical gloves. {1}------------------------------------------------ # Section E - 2 - 510(k) Summary (continued) ### Intended Use of the Device: Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves is a disposable device made of synthetic material that may bear trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination. ## Summary of Technological Characteristics Compared to the Predicate Device: Medigloves® Sterile Powder-free Synthetic Polyisoprene Latex Surgical Gloves posses the following technological characteristics (as compared to ASTM or equivalent standards). Dimensions : Meets ASTM D3577-01a22 Physical Properties : Meets ASTM D3577-01a22 Freedom from pinholes : Meets ASTM D3577-01a22 Meets ASTM D5151-99 Powder-Free : Meets ASTM D6124-01 2 mg/glove maximum Sterility : Meets ASTM D3577-01a82 ## Brief Discussion of Nonclinical Tests : Primary irritation testing in the rabbits and sensitization testing on the mice indicate no irritation or sensitization. ## Brief Discussion of Clinical Tests : Clinical data are not needed for surgical gloves. ## Conclusions Drawn for the Nonclinical and Clinical Tests : Nonclinical laboratory and animal data indicate that Medigloves® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves meets all performance and biocompatibility requirements. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal for 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 image of an eagle. Public Health Service APR 1 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medigloves Limited C/O Mr. Kobby Dankwah Medigloves Representative Westminster Capital, Incorporated 9665 Wilshire Boulevard, Suite M-10 Beverly Hills, California 90212 Re: K050181 Trade/Device Name: Medigloves® Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves (Green) Regulation Number: 878.4460 Regulation Name: 878.4460 Regulatory Class: II Product Code: KGO Dated: January 26, 2005 Received: January 31, 2005 Dear Mr. Dankwah: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined the device is substantially equivalent (for the itelerenced above and nave actecinclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinens, of to devices that have oost (Act) that do not require approval of a premarket the rederal Pood, Drug, and Conners , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fist. Food, listing of devices, good manufacturing practice, requirements for sibitions 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 (PMA), it may oc subject to such adata and Regulations, Title 21, Parts 800 to 898. In your device can be found in the South no mouncements concerning your device in the Federal Register. {3}------------------------------------------------ #### Page 2 -Mr. Dankwah Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC s lestainer on that your device complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and registments, including, but not limited to: registration 1 ou must comply with an the Pieceling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), labeling (21 CFR Part 820); and if requirents as set form in the quality special (S) (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) This letter will anow you to begin mainerally your device of your device to a premarket notification. - The PD 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), If you desire specific at rio to for your 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of 0101638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chris 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}------------------------------------------------ . | Section D-1 – Statement of Indications for Use | | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Indications for Use | | | | 510(k) Number (if known) : | K050181 | | | Device Name : | Medigloves ^® Sterile Powder-free Synthetic Polyisoprene Surgical Gloves (Green) | | | Indications For Use: | A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. | | | | <div> <p>Sheila P. Magilay</p> <p>(Division Sign-Off)</p> <p>Division of Anesthesiology, General Hospital, Infection Control, Dental Devices</p> </div> | | | 510(k) Number: | K050181 | | | Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 . :