NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)

{0}------------------------------------------------ Mar-13-98 12:02P G S I APR - 2 1998 P.04 | | K980729 | |--|---------| |--|---------| | | PT. EKA WIRA ASIA | |--|--------------------------------| | | Jl. Haji Zainal Arifin 128 B-C | | | Medan 20112 - Indonesia | | | Tel. 62-61-328888 (Hunting) | |--|-----------------------------| | | 62-61-520688 (Direct) | | | 62-61-730008 | | | Fax. 62-61-520588 | | | 62-61-730008 | | | Page Numbers 1 of 2 | |-----------------------|----------------------------------------| | | SUMMARY OF 510(K) SUBMISSION # K980729 | | (1) Name of applicant | : Mr. Hansen Laurence | | Address | : PT. EKA WIRA ASIA | | | Jl. Haji Zainal Arifin 128 B-C | | | Medan 20112 - Indonesia | | Phone No. | 62-61-328888; 62-61-730008 | | Fax No. | 62-61-520588; 62-61-730007 | The contact persons within the firm as well as in U.S.A. are given below: | Contact person in firm | : Mr. Hansen Laurence | |--------------------------|----------------------------| | Fax No. | 62-61-520588; 62-61-730007 | | Contact person in U.S.A. | : Emmy Tjoeng | | Fax No. | 562-693-8866 | | (2) Device details | | |----------------------------------------|---------------------------------------------------------------| | Trade Name | : Private Label - Nitrile Examination Gloves | | | Pre-Powdered, Blue and White Color | | Classification Name | : Patient Examination Gloves | | Product Code | : Nitrile 80 LZA | | (3) Equivalent device legally marketed | : Class I Nitrile Examination Gloves 80 LZA Pre-Powdered | | | meeting ASTM D 3578 - 95 | | (4) Intended use | : A patient examination glove is a disposable device intended | | | for medical purpose that is worn on examiner's hand or finger | | | to prevent contamination between patient and examiners. | 2121 FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows a black and white logo. The logo is circular and contains a figure standing with their legs apart and arms raised. Above the figure are several lines radiating outwards, resembling sun rays. There are also two horizontal lines on either side of the figure. EKA WIRA ASIA Jl. Haji Zainal Arifin 128 B-Medan 20112 - Indonesia "|"click. 62-61 - 328888 (11. 62-61 - 520688 (1)ire 62-61 - 730008 ドはメ 62-61 - 520588 62-61 - 730008 Page Numbers 2 of 2 After Aging at 100° for 22 hrs AQL # SUMMARY OF 510(K) SUBMISSION # K980729 - (5) Technological characteristic of the gloves. - g. Dimensions | SIZES | SMALL | MEDIUM | LARGE | |------------------------------------------------------|--------------------|--------------------|---------------------| | Length (min) mm<br>Palm width mm<br>Thickness | 240<br>$85 \pm 10$ | 240<br>$95 \pm 10$ | 240<br>$111 \pm 10$ | | 1. Cuff (min)<br>2. Palm (min)<br>3. Fingertip (min) | 0.1<br>0.1<br>0.1 | 0.1<br>0.1<br>0.1 | 0.1<br>0.1<br>0.1 | - h. Physical Properties | Tensile Strength | 14 Mpa | 14 Mpa | |---------------------------|--------|--------| | Ultimate Elongation (min) | 700 % | 500 % | Before Aging Performance Requirement i. Inspection Related defeats Characteristic Level | Watertightness | Holes | S - 4 | 2.5 | |---------------------|----------------------------|-------|-----| | Dimension | Width, length<br>Thickness | S - 2 | 4 | | Physical Properties | Before & After<br>Aging | S-2 | 4 | Weight of residual powder in medium size gloves: 150 ± 50 mg j. | k. Bio-Compatibility (attached) | Annexure XI | |----------------------------------------------------|-------------| | l. Test Results as per ASTM D 3578 - 95 (attached) | Annexure V | - (6) Performance data is the same as mentioned immediately above. - (7) Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. - (8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meet FDA pin holes requirement. Meet labeling claim. FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 2 1998 PT. Eka Wira Asia ·C/O Ms. Emmy Tjoeng Official Correspondent for PT, Eka Wira Asia Glove Source, Incorporated 12110 East Slauson Avenue #3 Santa Fe Springs, California 90670 Re : K980729 Nitrile Examination Gloves - Powdered Blue Trade Name: and White Requlatory Class: I LZA Product Code: February 23, 1998 Dated: February 25, 1998 Received: Dear Ms. Tjoeng: 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 requlations 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {3}------------------------------------------------ Page 2 - Ms. Tjoeng 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.fdag.gov/cdrh/dsmamain.html". Sincerely yours, K. Whitaker Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/3 description: The image is a black and white logo. The logo features a stylized figure standing with legs apart and arms raised, resembling a person or abstract form. Above the figure, there are radiating lines that suggest sunlight or energy emanating from the figure. The figure and radiating lines are set against a backdrop of two curved shapes that create a sense of enclosure or containment. # EKA WIRA ASIA Jl. Haii Zainal Arifin 128 B-C Medan 20112 - Indonesia 62-61 - 328888 (Illunling) . ان ا 62-61 - 520688 (1)recel) 62-61 - 73000x 62-61 - 520588 ドは、 62-61 - 730008 ## ANNEXURE II ### INDICATION FOR USE : Mr.Hansen Laurence Applicant : : K980729 510(k) Number Device Name : Nitrile Patient Examination Gloves - Powder . Blue and White Color Indication for use A patient examination glove is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiners. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Division of Dontal, Infection Control, and General Hospital Device (Division Sign-Oif) 510(k) Number OR Over-The Counter-Use X (Optional Format 1-2-96) FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG 4