LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a stylized logo or graphic. The letters "Ma" are prominently displayed in a bold, sans-serif font. The letters are overlaid on a background of horizontal lines, creating a textured effect. The overall design is simple and modern, with a focus on the typography. # A AGUNG LAT MANUFACTURE OF LATEX GLOVE Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180 Page Numbers 1 of 2 13996 #### FEB 2 6 2002 "510 (K)" SUMMARY | (1) Name of applicant | : Mr. Hansen Laurence | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | : PT. MAJA AGUNG LATEXINDO<br>Jl. Utama No. 98 Puji Mulio<br>Sunggal -Deli Serdang<br>North Sumatra - Indonesia | | Phone No. | : 62-61-845-9170 | | Fax No. | : 62-61-845-9180 | | 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. | : 62-61-845-9180 | | Contact person in U.S.A | : Emmy Tjoeng | | Fax No. | : 909-591-8878 | | (2) Device details<br>Trade Name | : Latex Powder free Sterile Examination Gloves | | Classification Name | : Latex Powder free Sterile Examination Gloves | | (3) Product Code | : Latex 80 LYY | | (4) Equivalent device legally<br>marketed | : Class I Latex Examination Gloves 80 LYY<br>Pre - Powdered meeting ASTM D 3578 – 01<br>Sterilized by gamma radiation | | (5) Intended use | : A latex examination glove is a disposable device intended<br>for medical purpose that is worn on examiner's hand or<br>finger to prevent contamination between patient and<br>examiners | {1}------------------------------------------------ # 196 Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180 Page Numbers 2 of 2 #### (6) Technological characteristic of the gloves. | Dimensions<br>Sizes | XS | S | M | L | XL | |----------------------------|-------------|--------------|--------------|---------------|--------------| | Length | 240 mm | 240 mm | 240 mm | 240 mm | 240 mm | | Width | $75\pm5$ mm | $80\pm10$ mm | $00\pm10$ mm | $105\pm10$ mm | $115\pm5$ mm | | THICKNESS<br>1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | | 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | | 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | - b. Physical Properties a. | | Before ageing | After ageing<br>at 70°C 168 hrs | |-----------------------|---------------|---------------------------------| | Tensile Strength : | 14 Mpa | 14 Mpa | | Ultimate Elongation : | 650 % (min.) | 600 % (min.) | #### c. Performance requirement | Characteristic | Related Defects | Inspection<br>Level | AQL | |-------------------------------------|--------------------------------------|---------------------|-----| | Sterility | Fails sterility | A | N/A | | Freedom from holes | Holes | 1 | 2.5 | | Dimensions<br>& Thickness | Width Length | S-2 | 4 | | Physical Properties<br>after ageing | Before and | S-2 | 4 | | Powder Free Residue | Exceeds Maximum Limit | N=5 | N/A | | Protein Content | Exceeds Recommended<br>Maximum Limit | N=3 | N/A | | Powder Amount | Exceeds Recommended<br>Maximum Limit | N=2 | N/A | (7) Performance data is the same as mentioned immediately above. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is a black and white logo. The logo has a large letter "L" on the left side. The letter "Ma" is written in cursive on the right side of the logo. The background of the logo has horizontal lines. **MAJA AGUNG LATE** MANUFACTURE OF LATEX GLO Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax. - (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 3578 - 01 Standard. Meets FDA pinhole requirement. Meets labeling claim. Meets the sterility assurance level. {3}------------------------------------------------ Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and body. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 2 6 2002 PT. Maja Agung Latexindo C/O Ms. Emmy T. Joeng Shamrock Marketing Company, Incorporated 5445 Daniel Street Chino, California 91710 Re: K013996 Trade/Device Name: Latex Powderfree Sterile Examiantion Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 29, 2001 Received: December 3, 2001 Dear Ms. Joeng: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becament mined the device is substantially equivalent (for the releveloca above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichements, or to do rood alle metic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, Lrag, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls providents or a 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it inch be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. or rouncements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {4}------------------------------------------------ You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Kane 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}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized graphic to the left of the company name in bold, sans-serif font. Above the company name is the number 013996. Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax. #### ANNEXURE II ## INDICATION FOR USE | Applicant | : Mr. Hansen Laurence | |--------------------|-----------------------------------------------| | Device Name | : Latex Powderfree Sterile Examination Gloves | | Indication for use | : | A sterile latex powderfree examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners. Sisan Pani (Tivision Sign-Off) Tivision Sign-Off) Dontal ("Tivision Sign-Off) Division of Dental, Infection Control, Division of Dental, Infection Devienti Division of General Hospital D r 10(k) Number -