DIGIFLEX SURGICAL GLOVES

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circle's perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 OCT 21 1997 Mr. Harsh Aqqarwal HMS Services, Incorporated 48 Alvin Road West Milford, New Jersey 07480 K972277 Re : Digiflex Surgical Gloves (Powdered) Trade Name: Requlatory Class: I Product Code: KGO September 8, 1997 Dated: Received: September 8, 1997 Dear Mr. Aggarwal: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Aggarwal through 542 of the Act for devices under the Electronic chrough 542 or the not 10 provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debting of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marree 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and old (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regulation chercica, "hibbranding a" "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health . Enclosure {2}------------------------------------------------ 3.0 INDICATIONS FOR USE STATEMENT: Include the following or equivalent Indications for Use page. The information , data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement. ## INDICATIONS FOR USE Applicant: DIGIFLEX INDIA LIMITED 2277 510(k) Number (if known): Device Name: Sterile Surgical Glove ( POWDERE Indications for Use: A Surgical Glove is a device made of natural or Synthetic rubber, intended to be worn by operating room personnel to protect a surgical wound from contamination. (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH Office of Device Evaluation (ODE) | | |----------------------------------------------------------------------|--------------------------------------------------------------------| | (Division Sign-Off) | | | Division of Dental, Infection Control, and General Hospital Devices, | | | 510(k) Number | K972277 | | Prescription Use Per 21 CFR 801.109 | OR | | | Over-The-Counter <span style="text-decoration: overline;">X</span> | * For a new submission, do NOT fill in the 510(k) number blank.