NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

{0}------------------------------------------------ # PT. MAHAKARYA INTI BUANA Image /page/0/Picture/1 description: The image shows a stylized logo with the letters "MB" in a gothic or old English font. The letters are bold and black, with a textured appearance that gives them a three-dimensional effect. The overall design is simple yet striking, with the letters overlapping slightly to create a unified visual element. K053366 Jalan Sei Belumai Desa Dalu 10 A Dusun 1 N Tanjung Morawa - 20562 SUMUT - INDONESIA MAR 3 0 2006 +62-61-7941880 l`el +62-61-7941882 l'ax # 510 (K) SUMMARY #### 1.0 Submitter: | Name | PT MAHAKARYA INTI BUANA | |-----------|-----------------------------------------------------------------------------------------------| | Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18<br>Tanjung Morawa - 20362<br>SUMUT - INDONESIA | | Phone No. | +62-61-7944880 | | Fax No. | +62-61-7944882 | Date of Summary Prepared: #### 2.0 Contact Person: | Name | : | Mr. Sasitharan Nair | |---------|---|---------------------| | Phone | : | +62-61-7944880 | | Fax No. | : | +62-61-7944882 | #### 3.0 Name or the device: | Trade Name | : | 1) Senstouch and<br>2) Multiple or Customers' Trade Name | |---------------------|---|----------------------------------------------------------| | Device Name | : | Powdered Nitrile Blue Examination Gloves, Blue. | | Non | : | Sterile | | Common Name | : | Examination Gloves | | Classification Name | : | Nitrile Examination Gloves (Class I) | #### 4.0 Identification of The Legally Marketed Device: Class I Nitrile Examination Gloves, 80LZA, powdered, that meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test. #### 5.0 Description of The Device The Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test. #### 6.0 Intended Use of The Device The Powdered Nitrile Examination Gloves, Blue, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner. 1 {1}------------------------------------------------ PT. MAHAKARYA INTI BUANA Image /page/1/Picture/1 description: The image shows a stylized logo with the letters "MB" in a bold, gothic-style font. The letters are large and take up most of the frame. The logo is black and white, with the letters appearing in solid black against a white background. The font style gives the logo a vintage or medieval appearance. Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa -- 20362 SUMUT - INDONESIA I el +62-61-7944880 +62-61-7944882 l·ax #### 7.0 Summary of The Technological Characteristics of The Device The Powdered Nitrile Examination Gloves, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------|---------------------------------------|----------------------------------------| | Dimension | D 6319-00aE3 | Meets | | Physical Properties | D 6319-00aE3 | Meets | | Freedom from Pinholes | D 6319-00aE3<br>FDA 21 CFR 800.20 | Meets | | Powder Residue | D 6319-00aE3<br>D6124 - 01 | 10 mg/dm² | | Biocompatibility | Primary Skin Irritation in<br>Rabbits | Passes<br>(No primary skin irritation) | | | Dermal Sensitization | Passes<br>(No contact sensitizer) | ### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above. ## 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for gloves or for most devices cleared by the 510 (k) processes. #### 10.0 Conclusion It can be concluded that The Powdered Nitrile Blue Examination Gloves, Blue, Non Sterile will perform according to the gloves performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged on a single line. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA MAR 3 0 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Sasitharan Nair Pt. Mahakarya Inti Buana J1 Sei Belumai, Desa Dalu 10 A Dusun I No. 18, Tanjung Morawa, Sumut Indonesia, 20362 Re: K053366 Trade/Device Name: Nitrile Examination Gloves, Powdered, Non Sterile Regulation Number: 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: March 3, 2006 Received: March 15, 2006 Dear Mr. Nair: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ ## Page-2 Mr. Sasitharan Nair 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. 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 continue 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chris Chiu Lin, Ph.D. Director Division of Dental, Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use # 510(k) Number (if known): 《OS-3366 Device Name: Indications For Use: NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE Powdered Nitrile Examination Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jula P. Murphy 3/30/06 y, General H. .31 K053344 Page 1 of 1