FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the letterhead for PT Mandiri Inti Buana. The letterhead includes the company name, address (Jalan Sei Belumai, Desa Dalu 10 A Dusun 1, Tanjung Morawa - 20362, SUMUT - INDONESIA), telephone number (+62-61-7944880), and fax number (+62-61-7944882). The date "OCT - 6 2005" is also present, along with the number K051987. ## 510 (K) SUMMARY | 1.0 | Submitter: | | | |-----|--------------------------|---|-----------------------------------------------------------------------------------------| | | Name | : | PT MANDIRI INTI BUANA | | | Address | : | Jl. Sei Belumai, Desa Dalu 10 A Dusun 1<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) Flexiskin and<br>2) Multiple or Customers' Trade Name | |---------------------|----------------------------------------------------------------------| | Device Name | Polymer Coated Latex Examination Gloves, Powder<br>Free, Non Sterile | | Common Name | Examination Gloves | | Classification Name | Patient Examination Gloves (Class I) | ### Identification of The Legally Marketed Device: 4.0 Class I Examination gloves, 80 LYY, Powder Free, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test. ### Description of The Device 5.0 The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile mects all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test. ### Intended Use of The Device 6.0 The Polymer Coated Latex Examination Glove, Powder Free, 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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a stylized logo or emblem consisting of the letters "MB" in a bold, gothic-style font. The letters are rendered in solid black, creating a strong contrast against the white background. The design appears to be hand-drawn or digitally created to mimic a hand-drawn aesthetic, with irregular edges and thick strokes that give it a somewhat rough and edgy appearance. The overall impression is that of a logo for a brand or organization with a bold, somewhat aggressive identity. ## PT MANDIRI INTI BUANA Jalan Sei Bclumai Desa Dalu 10 A Dusun 1 Taniung Morawa -- 20362 SUMUT - INDONESIA +62-61-7944880 ان ا 162-61-7944882 Fax ### 7.0 Summary of The Technological Characteristics of The Device The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile are summarized with the following technological characteristics compared to ASTM equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |----------------------------------|---------------------------------------|----------------------------------------| | Dimension | D 3587 -01 ae² | Meets | | Physical Properties | D 3587 -01 ae² | Meets | | Freedom from Pinholes | D 3587 -01 ae²<br>FDA 21 CFR 800.20 | Meets | | Powder Free Residue | D 3587 -01 ae²<br>D6124 - 01 | < 2 mg/glove | | Water Soluble Protein<br>Content | D 3587 -01 ae²<br>D 5712 - 99 | < 50 µg/g | | Biocompatibility | Primary Skin Irritation in<br>Rabbits | Passes<br>(No Primary Skin Irritation) | | | Dermal Sensitization | Passes<br>(No contact sensitizer) | - Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0 The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above. ### Substantial Equivalent Based on Assessment of Clinical Performance Data ಕ್ಕೆ () 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 Polymer Coated Latex Examination Gloves, Powder Free, 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 devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring four abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection. OCT 6 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. P. Sasitharan Nair TOM Manager Pt. Mandiri Inti Buana Jalan Set Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa, Sumut INDONESIA 20362 Re: K051987 Trade/Device Name: FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYY Dated: September 20, 2005 Received: September 29, 2005 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 application (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 such additional controls. Existing major regulations affecting (111) vice 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. 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. or the ret 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 and ifoune (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms retet 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), n you domact 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 maj volum 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/industry/support/index.html. Sincerely yours, Chiu-Liang PhD Chiu Lin, Ph.D. Director Division of 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): Device Name: POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE Indications For Use: > Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand 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) CRF801.109 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shilu A. Murphy, MD 11/4/15 (Division Sign Off) (Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Der 510(k) Number: N051987 Page 1 of _1____