Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them, possibly representing hair or movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 2, 2017 Semperit Investments Asia Pte. Ltd. % Thomas Knott Senior Regulatory Advisor Benjamin L. England & Associates, LLC 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061 Re: K160781 Trade/Device Name: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 27, 2017 Received: March 29, 2017 Dear Thomas Knott: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160781 ## Device Name Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves ### Indications for Use (Describe) The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Semperit, a company that specializes in rubber and plastic products. The logo consists of the word "SEMPERIT" in large, bold, blue letters, followed by a blue circle with a stylized "S" inside. The logo is simple and modern, and the blue color gives it a professional and trustworthy look. The logo is likely used on the company's website, marketing materials, and products. # 510(k) Summary #### 1.0 Submitter : Semperit Investment Asia Pte. Ltd. (SIA) 8 Jurong Town Hall Road, #29-03 to 06 The JTC Summit Singapore 609434 | Phone No. | : | +65 6705 2257 | |----------------|---|-----------------| | Fax No. | : | +65 6274 6977 | | Contact Person | : | Clemens Eichler | Date of Preparation April 20, 2017 #### 2.0 Name of the Device | Trade Name | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | |---------------------|-----------------------------------------------------------------------------| | Common Name | Synthetic Rubber Surgical Gloves | | Classification Name | Sterile Surgical Gloves | | 510(K) Number | K160781 | #### 3.0 Identification of The Legally Marketed Devices That equivalency is claimed: | Primary Predicate: | K013560 | |--------------------|---------| |--------------------|---------| | Name of the Device: | Sempermed® Supreme | |---------------------|-----------------------------------------------------| | Company: | SEMPERIT TECHNISCHE PRODUKTE<br>GESELLSCHAFT M.B.H. | #### 4.0 Description of the Device: Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SEMPERIT" in large, bold, blue letters. To the right of the word is a blue circle with a stylized "S" shape inside. The text and symbol appear to be a logo for a company or organization. settings, to provide a barrier against potentially infectious materials and other contaminants. #### 5.0 Indications for Use The Sterile Powder Free Synthetic Rubber Surgical Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. #### 6.0 Summary of the Technological Characteristics of the Device: The Sterile Powder Free Synthetic Rubber Surgical Gloves is summarized with the following technological characteristics compared to ASTM Specification D3577-09 Standard Specification for Rubber Surgical Gloves or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Dimensions | ASTM 3577-09 | Meets standard<br>requirements | | Physical Properties | ASTM 3577-09 | Meets standard<br>requirements | | Thickness | ASTM 3577-09 | Meets standard<br>requirements | | Biocompatibility | ISO 10993-10:2002/Amd<br>1:2006(E) Biological<br>evaluation of medical devices<br>– Part 10: Tests for irritation<br>and delayed-type<br>hypersensitivity – Amendment<br>1:2006-07-15 | Pass<br>Under the conditions of the<br>studies, the device is non-<br>irritating | | | ISO 10993-10:2002/Amd<br>1:2006(E) Biological<br>evaluation of medical devices<br>– Part 10: Tests for irritation<br>and delayed-type<br>hypersensitivity – Amendment<br>1:2006-07-15 | Pass<br>Under the conditions of the<br>studies, the device is a non-<br>sensitizer. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "SEMPERIT" in large, bold, blue letters, followed by a blue circular logo. The logo appears to be a stylized letter "S" enclosed within a circle. The text and logo are aligned horizontally and are the primary focus of the image. | Watertight (1000ml) | ASTM D 5151 | Pass | |---------------------|-------------|------| |---------------------|-------------|------| #### Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 7.0 The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above. #### 8.0 Substantial Equivalence Comparison | CHARACTER-<br>ISTICS | STANDARDS | DEVICE PERFORMANCE | | CONCLUSION | |----------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | | | | | | | Predicate | Current | | | Applicant | | Semperit Technische<br>Produkte GmbH & Co<br>KG | Semperit<br>Investment<br>Asia Pte, Ltd. (SIA) | | | 510(k) Number | | K013560 | K160781 | | | Dimensions | ASTM D3577 | Meets, | Meets, | Identical | | | $\leq$ 0.10 mm | Min 0.10 mm | Min 0.10 mm | | | Physical<br>Properties<br>Before Aging | ASTM D3577 | Meets, | Meets, | Identical | | Tensile Strength: | $\geq$ 17 MPa | 24 MPa min | 17 MPa min | | | Ultimate<br>Elongation: | 650 % min | 750% min | 650% min | | | Stress at 500%<br>Elongation: | $\leq$ 7.0 MPa | 7.0 MPa | 7.0 MPa | | | Physical<br>Properties After<br>Aging | ASTM D3577 | Meets, | Meets, | Identical | | Tensile Strength: | $\geq$ 12 MPa | 18 MPa min | 12 MPa min | | | Ultimate<br>Elongation | 490 % min | 560 % min | 490 % min | | | Powder Free | ASTM D6124-06 | Meets, | Meets, | Identical | | | | Requirements of $\leq$ 2 | Requirements of $\leq$ 2 | | | CHARACTER-<br>ISTICS | STANDARDS | DEVICE PERFORMANCE | | CONCLUSION | | | (≤ 2 mg/glove) | mg/glove for Powder-<br>Free designation per<br>ASTM D3577 | mg/glove for Powder-<br>Free designation per<br>ASTM D3577 | | | Sterile or Non-<br>sterile | - | Sterile | Sterile | Identical | | Biocompatibility | Primary Skin<br>Irritation<br>ISO 10993-10 | Under the conditions of<br>the studies, the device<br>is non-irritating | Under the conditions of<br>the studies, the device is<br>non-irritating | Identical | | | Dermal<br>Sensitization -<br>ISO 10993-10 | Under the conditions of<br>the studies, the device<br>is a non-sensitizer | Under the conditions of<br>the studies, the device is<br>a non-sensitizer | Identical | | Watertight<br>(1000ml) | ASTM D5151 | Passes<br>ASTM D3577 when<br>tested in accordance<br>with ASTM 5151<br>Inspection Level 1,<br>AQL 1.5 | Passes<br>ASTM D3577 when<br>tested in accordance<br>with ASTM 5151<br>Inspection Level 1,<br>AQL 1.5 | Identical | | Intended use | - | A surgeon's glove is a<br>device made of natural<br>or synthetic rubber<br>intended to be worn by<br>operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | The Sterile Powder Free<br>Synthetic Rubber<br>Gloves is a single use<br>disposable device<br>intended to be worn by<br>operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | Identical | | Material | ASTM D6319-10 | Natural Latex | Synthetic Rubber | Similar | | Innercoating | - | Synthetic | Synthetic | Identical | | Color | - | Natural White | Crème | Similar | | CHARACTER-<br>ISTICS | STANDARDS | DEVICE PERFORMANCE | DEVICE PERFORMANCE | CONCLUSION | | Texture | - | Textured (Micro-rough) | Textured (Micro-rough) | Identical | | Size | - | 51/2, 6, 61/2, 7, 71/2, 8, 81/2, and 9 | 51/2, 6, 61/2, 7, 71/2, 8, 81/2, and 9 | Identical | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SEMPERIT" in blue, block letters. To the right of the word is a blue circle with a stylized "S" shape inside. The logo is simple and clean, with a focus on the company name and a recognizable symbol. The color scheme is limited to blue and white. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "SEMPERIT" in large, bold, blue letters, followed by a blue circle with a stylized "S" inside. The font is sans-serif and appears to be a company logo. The logo is simple and modern. #### 9.0 Conclusion There is no significant difference between the two devices. While the two devices use different materials, both devices meet ASTM standards, FDA's requirement for water leak testing, and other considerations. Since the intended use is the same and they have the same technological characteristics, therefore, the new device is substantially equivalent to the predicate.