VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE

{0}------------------------------------------------ MAY - 4 2005 K 0409/6 | 510(k) Summary | |----------------| |----------------| | Date: | March 24, 2004 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Submitter: | VitalCare Group Inc.<br>8935 NW 27th Street<br>Miami Fl. 33172 | | Contact: | Michael McAvenia<br>Director of Quality Assurance<br>(305) 620-4007<br>Fax: (305) 620-5220<br>Internet: michaelm@vitalcare.com | | Establishment Number: | 1063200 | | Address of Manufacturing Site: | VitalCare Malaysia, SDN BHD, Inc.<br>Lot 7, Jalan 16/11<br>Shah Alan - Selangor<br>Malaysia | | Name of Device: | VitalCare Powder Free Synthetic Vinyl Examination<br>Glove | | Predicate Device: | VitalCare Vinyl Powdered Examination Glove | | Device Common and Classification Name(s): | | |-------------------------------------------|-----------------------------------------------------------------------------------------------| | | Common Name: Powder Free Exam Glove<br>Classification Name: Glove, Patient Examination, Vinyl | | Classification Information: | | | | | | | | | | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------|--------|------------------|---------------|-----|-------|----------| | | | | | | | | | | | | | <table><tr><td>Class:</td><td>Class I</td></tr><tr><td>Panel:</td><td>General Hospital</td></tr><tr><td>Product Code:</td><td>LYZ</td></tr><tr><td>Cite:</td><td>880.6250</td></tr></table> | Class: | Class I | Panel: | General Hospital | Product Code: | LYZ | Cite: | 880.6250 | | Class: | Class I | | | | | | | | | | Panel: | General Hospital | | | | | | | | | | Product Code: | LYZ | | | | | | | | | | Cite: | 880.6250 | | | | | | | | | {1}------------------------------------------------ Intended Use of the New Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment Guidance Documents: ASTM -D-5250-00, ASTM- D-6124-01, FDA 1000 ml Water Leak Test. {2}------------------------------------------------ | Feature\Claim | Detail | Predicate | |---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Intended Use | A patient examination glove is a disposable device<br>intended for medical purposes that is worn on the<br>hand of healthcare professional and similar personnel<br>to prevent contamination between the healthcare<br>personnel and the patient's body, fluids, waste or<br>environment | Similar | | Materials | Vinyl, Synthetic<br>Plastic Bag<br>Corrugated | Similar<br>Similar<br>Similar | | Labeling | VitalCare Powder Free Synthetic Vinyl Examination<br>Glove<br>Reorder Number<br>Size<br>Quantity<br>Non - Sterile, pouch and shipping case<br>Manufacturer Address | Powdered<br>Similar<br>Similar<br>Similar<br>Similar<br>Similar<br>Similar | | Packaging | One plastic bag, 100 pouches per case | Similar | {3}------------------------------------------------ ## Labels, Labeling: See Attachments : ! Package labels: Copies of the labels for the Powder Free Synthetic Vinyl Exam glove pouch and shipping case are included. See Attachment 1 Promotional Materials: No promotional materials have been developed for this device. Engineering Drawings: Engineering drawings, with dimensions and tolerances, are included in Attachment 2 Performance Data: VitalCare Powder Free Vinyl Examination Glove meets all requirements for ASTM Standard D-5250-00 physical and dimensional testing, ASTM D6124-01 for starch to determine the gloves meet the powder free claim, no more than 2mg powder per glove. FDA 1000ml Water Leak Test. Primary Skin Irritation and Skin Sensitization tests demonstrate no skin irritation or sensitization. Comparative Claims: No comparative claims are made for the VitalCare Powder Free Synthetic Vinyl Examination glove. The glove is not claimed as hypoallergenic. It will not be compared in labeling or advertising to other devices. Unique Designs: The design of the VitalCare Powder Free Vinyl Examination Glove is not unique. Sterilization Information: Bulk Non - Sterile Description of the Marketed Equivalent Device: Classified by FDA's General Hospital Panel as Class I, 21 CFR 880.6250, Powdered Vinyl Examination Glove, 880 LYZ meets all the requirements of ASTM Standard D5250-00 Device Trade or Proprietary Name: VitalCare Powdered Vinyl Examination Glove Device Common and Classification Name(s): Common Name: Powdered Exam Glove Classification Name: Glove, Patient Examination, Vinyl {4}------------------------------------------------ Classification Information: Class I Panel: General Hospital Product Code: LYZ Cite: 880.6250 ## Document Control Number: K 992289 Type of Device: Patient Examination Glove Use with other devices: N\A Intended Use of the Marketed Equivalent Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment. Labels and Labeling: See Attachment 3 Summary of technological characteristics of new device compared to predicate device: The proposed device has the same technological characteristics and is substantially equivalent to the predicate device, however, the glove is not powdered. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the central emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 4 2005 Mr. Michael McAvenia Director, Quality Assurance VitalCare Group, Incorporated 15800 NW 13th Avenue Miami, Florida 33169 Re: K040916 Trade/Device Name: VitalCare Powder Free Synthetic\Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 1, 2005 Received: April 20, 2005 Dear Mr. McAvenia: 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your de roe is onabitional controls. Existing major regulations affecting (1 Writ), it may be backed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to real rot 10 loasish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ ## Page 2 - Mr. McAvenia 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 modi that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ouchar time Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice und noting (21 et read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic 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 premiurner notified 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), 11 you dosite specific across 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 maj vours 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/industry/support/index.html. Sincerely yours, Spute Y. Michai O ms. Chíu 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 {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K040916 Device Name: VitalCare Powder Free Synthetic\Viry| Examination Glove Indications for Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between the patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Shade P. Murphy S. 305 Page 1 of (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: 11:3