NITRILE GLOVES

{0} Aug. 20. 1997 5:54AM SAGE PRODUCTS INC No. 4554 3/5 SAGE PRODUCTS INC K970135 Examination AUG 25 1997 # 14 510(k) Summary for Sage Nitrile Gloves, K970135 This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 90. | Submitter Name | Karen Pinto, Regulatory Affairs Manager | | --- | --- | | Company Name | Sage Products Inc. | | Street Address | 815 Tek Drive, Crystal Lake, IL 60014 | | Contact Person | Karen Pinto, Regulatory Affairs Manager | | Telephone of Contact Person | 815-455-4700 ext. 1383 | | Fax of Contact Person | 815-455-5599 | | Date of Summary Preparation | May 8, 1997 | | Device Name | | | Trade or Proprietary Name | Nitrile Gloves (POWDER FREE EXAMINATION GLOVE) | | Classification Name | Patient Examination Gloves (CFR: 800.6250) | | Common Name^{1} | Exam Gloves | | Indications for Use | A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents. | | Description: | 8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with beaded cuff extending beyond the wrist. | Page 13 of 16 Response to 8/19/1997 Request for Revisions "Innovative health care products since 1971" 815 Tek Drive ■ P.O. Box 9693 ■ Crystal Lake, IL 60039-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599 {1} Aug. 20. 1997 5:54AM SAGE PRODUCTS INC No. 4564 P. 4/5 # SAGE # PRODUCTS INC ## 14 510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) ### Substantial Equivalence Comparison | Product Name | Nitrile Gloves | Safeskin | Nitrex | N-Dex | N-Dex | N-Dex | | --- | --- | --- | --- | --- | --- | --- | | Manufacturer | Sage Products, Inc. | Safeskin | Delta Hospital Supply, Inc. or Delta Medical Systems | Best | Best | Best | | Product Code | LZC Undetermined | N-110 | UNT-100 | 8005 | 9005 | 9905 | | K Number | Has not been assigned yet | Could not locate | Could not locate | Could not locate | K902696 | K915086 | | Address | Crystal Lake, IL | San Diego, CA | Norwood, Mass or Duluth, GA | Menlo, GA | Menlo, GA | Menlo, GA | | Intended Use of Product | Patient examination and personal protection | Patient examination and personal protection | Patient examination and personal protection | Personal protection, Food and Pharmaceutical | Patient examination, personal protection, Food and Pharmaceutical | Patient examination, personal protection, Food and Pharmaceutical | | Sizes available | xs, s, m, l, xl | xs, s, m, l, xl | s, m, l, xl | s, m, l, xl | s, m, l, xl | s, m, l, xl | | Material | Nitrile | Nitrile | Nitrile | Nitrile | Nitrile | Nitrile | | Orientation | Fitted and Ambidextrous | Ambidextrous | Ambidextrous | Ambidextrous | Fitted | Ambidextrous | | Cuff | Beaded | Beaded | Beaded | Beaded | Beaded | Beaded | | Color | White | Blue | Blue | Blue | Blue | Blue | | Product Code | Undetermined | N-110 | UNT-100 | 8005 | 9005 | 9905 | | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | | Length (in.) | 12 | 9 1/2 | 11 | 9 1/2 | 11 | 11 | | Fingertip Thickness (mil) | 8 | 6 | 6 | 8 | 6 | 6 | | Presence of Donning Powder | No | No | No | Yes | Available with and without | Available with and without | Page 14 of 16 Response to 8/19/1997 Request for Revisions "Innovative health care products since 1971" 815 TEX DRIVE ■ P.O. Box 9693 ■ CRYSTAL LAKE, IL 60039-9693 815-455-4700 ■ 800-323-2220 ■ FAX: 815-455-5599 {2} Aug. 20. 1997 5:55AM SAGE PRODUCTS INC 30.4334 5/5 SAGE PRODUCTS INC # 14 510(k) Summary for Sage Nitrile Gloves, K970135 (Continued) ## Performance Test Summary The Sage nitrile glove have been tested per the following standards - 21 CFR 800.20 - ASTM D412 - ASTM 1342-91 - ASTM 739-91 - NFPA 1999 - Blue Book Memorandum #G95-1, Sensitization, and Primary Irritation Testing Page 15 of 16 Response to 8/19/1997 Request for Revisions "Innovative health care products since 1971" 815 TEK DRIVE ■ P.O. Box 9693 ■ CRYSTAL LAKE, IL 60039-9693 815-455-4700 ■ 800-323-2220 ■ FAX: 815-455-5599 {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Karen Pinto Regulatory Affairs Manager Sage Products Incorporated 815 Tek Drive P.O. Box 9693 Crystal Lake, Illinois 60014-9693 AUG 25 1997 Re: K970135 Trade Name: Sage Powder-Free Nitrile Examination Gloves Regulatory Class: I Product Code: LZC Dated: May 23, 1997 Received: June 3, 1997 Dear Ms. Pinto: 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 action. In addition, FDA may publish further announcements 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 {4} Page 2 - Ms. Pinto through 542 of the Act for devices under the Electronic Product Radiation Control 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} Aug. 18. 1997 12:08PM SAGB PRODUCS .NC No. 4042 1. 5/7 Page 1 of 1 510(k) Number (if known): K970135 Device Name: Sage Nitrile Gloves (POWDER FREE EXAMINATION GLOVE) Indications For Use: A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents. [Section 15, page 16 of 16, Pre-Market Notification: Nitrile Gloves] (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 K970135 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use ☑ (Optional Format 1-2-96)