SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT

{0}------------------------------------------------ K991744 # APPENDIX G ## 510(K) SUMMARY # SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR SMART SHIELD POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT ## Contact person : Ong Lay Mau This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. ## Device Information: | Trade Name | - SMART SHIELD™ POWDER FREE COLORED NITRILE | |----------------------------|--------------------------------------------------------------------| | | EXAMINATION GLOVES WITH BUBBLE GUM SCENT | | Common Name | - Exam gloves | | Classification Name | - Patient examination glove (per 21 CFR 880.6250) | | Classification Information | - Class I, 80 LZA - Nitrile patient examination glove, Powder free | | | Meets all requirements of the ASTM Draft Standard Specification | | | for Nitrile Examination Gloves for Medical Application. | ## Device Description: Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application. ## Intended Use of Device: A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient. ## Technological Characteristics of Device: ### 1. Dimension | DIMENSION | ASTM D3578-95 | ROYAL SHIELD | |------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------| | Small<br>Medium<br>Medium-Large<br>Large | 80 mm +/- 10mm<br>90 mm +/- 10mm<br>100mm +/- 10mm<br>111mm +/- 10mm | 80 - 85 mm<br>90 - 97 mm<br>105 - 110 mm<br>111 - 114 mm | | Length | 230 mm minimum<br>for all sizes | 240mm min.<br>for all sizes | | Thickness -<br>Finger<br>Palm | 0.08mm minimum<br>0.08mm minimum | 0.08 mm min.<br>0.08 mm min. | {1}------------------------------------------------ K991744 ## 2. Physical Properties | TESTS | TENSILE STRENGTH | | | ULTIMATE ELONGATION | | | |----------------------------------|-------------------|--------------------------|---------------------------|---------------------|--------------------------|---------------------------| | | ASTM<br>D 3578-95 | ASTM<br>DRAFT<br>NITRILE | SHIELD<br>GLOVES<br>MFR'S | ASTM<br>D 3578-95 | ASTM<br>DRAFT<br>NITRILE | SHIELD<br>GLOVES<br>MFR'S | | BEFORE<br>AGING | 14.0 MPa | 12.5 MPa | 18.0 MPa | 700% | 500% | 600% | | AFTER AGING<br>22 HRS @<br>100°C | 14.0 MPa | 12.5 MPa | 16.0 MPa | 500% | 400% | 500% | Our Smart Shield™ Powder free, Colored Nitrile Gloves with Bubble Gum Scent meets all the current ASTM D 6319-99 standards for Nitrile Examination Gloves. # 3. Water Tight Test Using the FDA specified 1,000 ml water leak test, 200 pieces of each size of the gloves were tested following G1 single sampling plan and our results are as given below: | BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED | |------------|---------|-------------|-------------|------------------| | 9904071315 | Small | 200 | Yes | 4 | | 9904061313 | Medium | 200 | Yes | 1 | | 9904061313 | M-Large | 200 | Yes | 2 | | 9904061313 | Large | 200 | Yes | 3 | The above meets the FDA Water Leak Test Requirements. ## 4. Biocompatibility The test results below shows that the gloves meet FDA biocompatibility requirements: | BIOCOMPATIBILITY TESTS | RESULTS | |--------------------------------|---------| | Primary Dermal Irritation Test | Passes | | Skin Sensitization Study | Passes | {2}------------------------------------------------ # 5. Total Residual Powder Content & Presence of Cornstarch | TESTS | FDA INTERNAL<br>REQUIREMENTS | SHIELD GLOVES MFR'S | |-------------------------------------------|---------------------------------|---------------------------------------------------| | RESIDUAL POWDER<br>CONTENT<br>ASTM D 6124 | NOT EXCEEDING<br>2 Mg PER GLOVE | RANGE:1.4-1.9 Mg/ GLOVE<br>MEAN :1.7 Mg PER GLOVE | | CORNSTARCH PRESENCE<br>(IODINE TEST) | NEGATIVE | NEGATIVE | The glove conforms to FDA's proposed requirement not to exceed 2 mg/glove of total powder residue (using ASTM D 6124 Method for Residual Powder on Medical Gloves) and negative Iodine test. # CONCLUSION :- It is concluded that the Smart Shield™ Powder Free, Colored Nitrile with Bubblegum scent gloves meet:- - ASTM D 3578-95 specifications. - FDA proposed requirement not to exceed 2 mg/glove of total powder residue per ASTM D 6124. - ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves - the FDA Water Leak Test requirements per ASTM D 5151. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, which is the department's emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 3 1999 Shield Gloves Manufacturer (M) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114 Re : K991744 SMART SHIELD™ Powder-Free Blue Nitrile Trade Name: Examination Glove with Bubble Gum Scent Requlatory Class: I Product Code: LZA Dated: May 10, 1999 Received: May 21, 1999 Dear Mr. Smith: 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Reqister. {4}------------------------------------------------ Page 2 - Mr. Smith this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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.qov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowsk Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K991744 # INDICATIONS FOR USE STATEMENT Applicant: Shield Gloves Manufacturer (M) Sdn Bhd. 510K Number: Device Name: SMART SHIELD TM Powder Free Colored Nitrile Examination Gloves With Bubblegum Scent Indications For Use : This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient. .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use ... ... ... ... ... ..... Per 21 CFR 801.109 OR Over-The-Counter........X Chin S. Lim (Division Sign-Division of Dental, Int and General Hospita 510(k) Number