FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE

{0}------------------------------------------------ K 042239 Image /page/0/Picture/1 description: The image shows a stylized, gothic-style monogram consisting of the letters 'M', 'I', and 'B'. The letters are rendered in a bold, black color, with sharp, angular edges that give them a medieval or fantasy-like appearance. The design is compact and the letters are closely intertwined, creating a unified and distinctive logo or emblem. 1.0 PT MANDIRI INTI BUANA DEC 1 6 2004 Jalan Sei Belumai Desa Dalu 10 A Dusun I Tanjung Morawa - 20362 SUMUT - INDONESIA +62-61-7944880 Tel Fax +62-61-7944882 ## 510 (K) SUMMARY | Submitter: | | |------------|-----------------------------------------| | Name | PT MANDIRI INTI BUANA | | Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I | | | Tanjung Morawa - 20362 | | | 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 | |---------------------|---|----------------------------------------------------------------------| | | | 2) Multiple or Customers' Trade Name | | Device Name | : | Powder Free Nitrile Blue Examination Gloves,<br>Blue, Non<br>Sterile | | Common Name | : | Examination Gloves | | Classification Name | : | Nitrile Blue Examination Gloves (Class I) | ### 4.0 Identification of The Legally Marketed Device: Class I Nitrile Examination Gloves, 80LZA, powder free, that meets all the Test. ### 5.0 Description of The Device The Powder Free 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 Powder Free 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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a stylized logo with the letters "MB" in a gothic-style font. The letters are bold and black, with intricate details and sharp edges. The overall design has a vintage or medieval feel, with the letters slightly overlapping each other. Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA +62-61-7944880 Tel +62-61-7944882 Fax ### Summary of The Technological Characteristics of The Device 7.0 The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 | < 2 mg/glove | | Biocompatability | Primary Skin Irritation in<br>Rabbits<br>Dermal Sensitization | Passes<br>(No primary skin irritation)<br>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) process. ### Conclusion 10.0 It can be concluded that The Powder Free 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a stylized, black and white logo or emblem. It features two large, bold letters, 'M' and 'B', interlocked or placed closely together. The font style is somewhat gothic or medieval, with thick strokes and sharp angles, giving the letters a strong, imposing appearance. The overall design is simple yet striking, making it easily recognizable. Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT – INDONESIA +62-61-7944880 Tel +62-61-7944882 Fax ### Premarket Notification 510 (k) Submission Applicant: 1.0 | Name | : PT MANDIRI INTI BUANA | |-----------|------------------------------------------------------------------------------------------| | Address | : Jl. Sei Belumai, Desa Dalu 10 A Dusun I<br>Tanjung Morawa - 20362<br>SUMUT - INDONESIA | | Country | : INDONESIA | | Phone No. | : +62-61-7944880 | | Fax No. | : +62-61-7944882 | #### 1.1 Activity of Applicant: [ ] Importer [V] Manufacturer | Repacker [ ] Other [V] Contact Manufacturing | Consultant ### 1.2 Contact Person: Proprietary or Trade Name: | Name | : | Mr. Sasitharan Nair | |---------|---|---------------------| | Phone | : | +62-61-7944880 | | Fax No. | : | +62-61-7944882 | ### Truthful and Accurate Statement: As shown in Attachment A 2.0 - Indication for Use Statement: As shown in Attachment B 3.0 - Trade Name: 4.0 1) Glovetex and 2) Multiple Free Nitrile Examination Gloves, Blue, Non Sterile. ### 5.0 Name and Location of ACTUAL Manufacturer: | Name | PT MANDIRI INTI BUANA | |-----------|-----------------------------------------| | Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I | | | Tanjung Morawa - 20362 | | | SUMUT – INDONESIA | | Country | INDONESIA | | Phone No. | +62-61-7944880 | | Fax No. | +62-61-7944882 | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a stylized logo with 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 font choice gives the logo a vintage or medieval feel. The letters are slightly distorted, adding to the unique character of the design. Jalan Sci Bclumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA Tel +62-61-7944880 +62-61-7944882 Fax ### 6.0 Labels, Labeling and Advertisings: Copy of dispenser box labeling is provided in Attachment C ### 7.0 Classification Information: - 7.1 Device Class: I - 7.2 Substantial Equivalent Device Description: Nitrile Examination Gloves ### 7.3 Product Code - [] Vinyl 80 LYZ - [ ] Polymer 80 LZA - [] Specialty 80 LZC - [] Finger Cot 80 LZB - [ ] Other 80 FMC = = - [V] Nitrile 80 LZA - [ ] Latex 80 LYY - [] Latex (Powdered) LYY - [] Latex (Powder-free) 80 LYY - [ ] Latex (hypoallergenic) 80 LYY - [ ] Latex ( powder-free/hypoallergenic- 80LYY - ] Latex (protein label claim) 80 L Y Y ### 8.0 Specifications: | Size | 230 | WIDTH, mm | |------|-----|--------------| | XS | 230 | $70 \pm 10$ | | S | 230 | $80 \pm 10$ | | M | 230 | $95 \pm 10$ | | L | 230 | $111 \pm 10$ | | XL | 230 | $115 \pm 10$ | | SINGLE WALL THICKNESS, mm (minimum) | | |-------------------------------------|------| | Finger | 0.08 | | Palm | 0.08 | | | BEFORE AGING | AFTER AGING<br>At @ 100°C for 22 hr | |---------------------|--------------|-------------------------------------| | Tensile Strength | 14 MPa, min | 14 MPa, min | | Ultimate Elongation | 500 % min | 400 % min | ASTM Pinhole Requirements: Single, General Inspection Level G-1, AQL 2.5 ### Reference Performance Standards: 8.1 ASTM D 6319 - 00a53 Adherence: [V] FULL [ ] PATRIAL {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a stylized, black and white graphic of the letters "MB" in a gothic-style font. The letters are bold and textured, giving them a rough, almost medieval appearance. The overall design is simple yet striking, with the letters dominating the composition. Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA +62-61-7944880 Tel 462-61-7944882 Fax ### Quality Assurance Testing (of Finished Gloves): 9.0 Does quality assurance conform to ALL ASTM D 6319-00a53 procedures and FDA water leak test? [V] YES [ ] NO A summary of Quality Assurance Testing Procedure, Sampling Plan and Acceptance Criteria for Gloves Inspection and Testing, and Device Test Report of Compliance of finished gloves are provided in Attachment D, E and F ### 10.0 Dusting Powder Information of Powder used is provided in Attachment #### Finished Powder Free Gloves: 11.0 Information for Finished Powder Free Gloves is provided in Attachment G #### 12.0 Colour Additive: A material safety data sheet for the colour additive used and colour fastness test report are provided in Attachment I and J ### 13.0 Glove Biocompatibility: Powder Free Nitrile Examination Glove, Blue, Non Sterile has been sent for biocompatibility test i.e. FDA Primary Skin Irritation Test and FDA Dermal Sensitization Test were performed on the finished gloves and the test result are provided in Attachment K and L respectively. {5}------------------------------------------------ Image /page/5/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. Inside the circle is an image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 1 6 2004 Mr. P. Sasitharan Nair Quality Regulatory Manager PT Mandiri Inti Buana Jalan Sei Belumai, Desa Dalu 10 A Dusun 1 Tanjung Morawa-20362 SUMUT-INDONESIA Re: K042239 Trade/Device Name: Powder Free Nitril Examination Gloves, Blue, Non Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 23, 2004 Received: November 26, 2004 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 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. {6}------------------------------------------------ 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. 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), 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 vours, 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 {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K 04 2 2 3 9 Device Name: POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE Indications For Ilse: pouder Eroe Nitrile Examination Gloves, Non Sterile is a disposable device and make of Synthetic Is a Gropodosatibits rubber like Characteristics Intended For Medical Purpose that is worn on the Incended roz finger to prevent contamination between patient and examiner - Prescription Use CERBO1 . 109 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONNIINUE ON ANOTHER PAGE IN NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sonette M. Chins Doos (Division Sign-Cip Division of Anesths stology Infection Control, Dental Dental Di 510(k) Number. K042239 Page 1 of