SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date November 5, 1999. The month is abbreviated to NOV. The day is the number 5. The year is 1999. K992752 Image /page/0/Picture/2 description: The image shows a close-up of the word "Ma" written in a stylized, cursive font. The letters are bold and black, contrasting with the white background. Horizontal lines run across the top portion of the image, creating a textured effect behind the letters. A black border is visible at the bottom and left side of the image, framing the word. ## PT. MAJA AGUNG LATEXINDO MANUFACTURING OF LATEX GLOVES Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180 Page Numbers 1 of 2 ### "510 (K)" SUMMARY | (1) Name of applicant<br>Address | : Mr. Hansen Laurence<br>: PT. MAJA AGUNG LATEXINDO<br>Jl. H. Yamin No. 40 - 40 A<br>Medan 20234<br>Indonesia<br>Phone No. : 62-61-328888 ; 62-61-859170<br>Fax No. : 62-61-520588 ; 62-61-520588 | |--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The contact persons within the firm as well as in U.S.A are given below: | | | Contact person in firm | : Mr. Hansen Laurence<br>Fax No. : 62-61-520588 : 62-61-859180 | | Contact person in U.S.A | : Emmy Tjoeng<br>Fax No. : 626-913-1498 | | (2) Device details<br>Trade Name | : Latex Surgeon's Gloves Pre-Powdered<br>Sterile | | Classification Name | : Latex Surgeon's Gloves Pre-Powdered<br>Sterile | | (3) Product Code | : 79 KGO | | (4) Equivalent device legally<br>marketed | : Class I Surgeon's Gloves 79 KGO<br>meeting ASTM D 3577 - Sterilized<br>by gamma radiation | | (5) Intended use | : A surgeon's glove is a disposable device intended for<br>medical purpose that is worn on surgeon's hands during<br>surgical operations to prevent contamination between<br>patient surgeon's | {1}------------------------------------------------ K992752 Image /page/1/Picture/1 description: The image shows a stylized logo with the letters "Ma" in a cursive font. The letters are black and stand out against a background of horizontal lines. The left side of the logo has a thick black vertical bar, and the bottom of the logo has a thick black horizontal bar. # PT. MAJA AGUNG LATEXINDO MANUFACTURING OF LATEX GLOVES Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180 Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA | a. Dimensions<br>Sizes | 6½ | 7 | 7½ | 8 | 8½ | |-------------------------------|----------|----------|----------|-----------|-----------| | Length mm (min.) | 265 | 265 | 265 | 265 | 265 | | PalmWidth mm | $83\pm6$ | $89\pm6$ | $95\pm6$ | $102\pm6$ | $108\pm6$ | | Thickness<br>1. Cuff mm (min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 | | 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 | | 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 | #### b. Physical Properties | | Before ageing | After ageing<br>at 70°C 168 hrs | |----------------------------|----------------|---------------------------------| | Tensile Strength | : 24 Mpa (min) | 18 Mpa (min) | | Ultimate Elongation | : 750 % (min.) | 560 % (min.) | | Stress at 500 % Elongation | : 5.5 (max) | : | #### c. Performance Requirement | Characteristic | Related Defects | Inspection<br>Level | AQL | |---------------------|-----------------------------|---------------------|----------------| | Watertight | Holes | S-4 | 1.5 | | Dimensions | Width Length<br>& Thickness | S-2 | 4.0 | | Physical Properties | Before and<br>after ageing | S-2 | 4.0 | | Sterility | Fails sterility | | Not Acceptable | - (7) Performance data is the same as mentioned immediately above. - (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process. - (9) Non-clinical data We certify that the gloves meet or exceed the ASTM D 3577Standard Meets FDA pin hole requirement. Meets labeling claim. Meets the sterility assurance level. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MUN - 5 1999 PT. Maja Aqunq Latexindo c/o Ms. Emmy Tjoeng Official Correspondent for PT. Maja Aqunq Latexindo Shamrock Marketing Company, Incorporated 889 South Azusa Avenue City of Industry, California 91748 Re : K992752 Trade Name: Pre-Powdered Sterile Latex Surgeon's Gloves Requlatory Class: I Product Code: KGO Auqust 11, 1999 Dated: Received: August 16, 1999 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 qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਉ 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 {3}------------------------------------------------ Page 2 - Ms. Tjoenq 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 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, Clutrust thy A. Ulatowski Diredtor 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/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '992752'. The digits are written in a simple, slightly irregular style, typical of handwriting. Image /page/4/Picture/1 description: The image shows a close-up of the letters 'Ma' in a stylized font. The letters are black and are set against a background of horizontal lines. The letters are bold and have a rounded appearance. ## MAJA AGUNG LATEXIN MANUFACTURING OF LATEX GLOVE Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180 ### ANNEXURE II ### INDICATION FOR USE | Applicant | : Mr. Hansen Laurence | |--------------------|--------------------------------------------------| | Device Name | : Latex Surgeon's Gloves Pre-Powdered<br>Sterile | | Indication for use | : | A latex surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hand during surgical operation to prevent contamination between patient and surgeon. (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) | | | | <i>Division Sign-Off</i> | | | Division of Dental, Infection Control, | | | and General Hospital Devices | | 510(k) Number | K992752 | | Over-The-Counter Use | X | | | (Optional Format 1-2-96) |