Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. January 8, 2018 Beta Healthcare Products Pvt. Ltd. % Manoj Zacharias President Liberty Management Group Ltd 75 Executive Dr., Ste 114 Aurora, Illinois 60504 Re: K172942 Trade/Device Name: Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: November 29, 2017 Received: December 5, 2017 Dear Manoj Zacharias: 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. {1}------------------------------------------------ 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Tina Kiang -S 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) K172942 #### Device Name Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein) #### Indications for Use (Describe) A latex surgeon's glove is a device made of natural rubber 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ # K172942 #### PAGE NO -1 #### 510K SUMMARY as required by: 21CFR § 807.92 A. APPLICANT INFORMATION | 1. | Submitter Name | Beta Healthcare Products Pvt.Ltd. | |----|----------------|-------------------------------------------------------------------------------------------| | | Date Submitted | November 29, 2017 | | | Address | Plot No 21B,<br>Cochin Special Economic Zone,<br>Kakkanad,Kochi-682037.<br>Kerala, India. | | | Phone | +91 484 2413389 , 2413390 | | | Fax | +91 484 2413341 | | | E-mail | betahealthcare@gmail.com | | | Contact Person | Boney Moolayil | | | Designation | Director | | | Contact Number | +91 974700797 | | | Contact Email | betahealthcare@gmail.com | #### B. US AGENT & CONTACT PERSON INFORMATION | 17 | US agent & contact person name | Manoj Zacharias | |----|--------------------------------|-----------------------------------------------------------------------------------| | 18 | Address | Liberty Management Group Ltd.<br>75 Executive Dr, STE 114, Aurora, IL-60504, USA. | | 19 | Phone | (630) 270-2921 | | 20 | Fax | (815) 986-2632 | | 21 | E-mail | manoj@libertymanagement.us | #### C. DEVICE IDENTIFICATION | Common Name | Surgeon's Glove | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Surgeon's Glove powder free | | Product proprietary or trade name | Pristeen (Latex Surgeon's Gloves<br>Powder Free, Polymer coated with<br>protein content labeling claim of 50<br>µg/dm² or less per glove of<br>extractable protein) | | Classification name | Surgeon's Glove | | Device Classification | 1 | | Product Code | KGO | | Regulation Number | 21 CFR 878.4460 | | Review Panel | Gen & Plastic Surgery | {4}------------------------------------------------ #### K172942 ## PAGE NO -2 #### D.PREDICATE DEVICE INFORMATION | Sl.No | Name of devices | 510k Number | 510K Owner | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------------------------------------------------| | Predicate device-1 | Medismart+ Latex Surgeon's<br>Glove powder free-polymer<br>coated with protein content<br>labeling claim of 50 $ \u00b5g $ /dm² or<br>less per glove of extractable<br>protein | K151114 | St.Marys Rubbers Pvt.Ltd.<br>Koovappally P.O,<br>Kanjirappally, Kottayam<br>District, Kerala State, India-<br>686518 | | Predicate device-2 | SURGTEX Latex Surgeon's<br>Glove powder free-polymer<br>coated with protein content<br>labeling claim of 50 $ \u00b5g $ /dm² or<br>less per glove of extractable<br>protein | K130450 | Purna Bina SDN BHD<br>Plo 5, Jalan Mahsuri, 7.5km,<br>Jalan Mersing,<br>Kluang Industrial Area<br>Kluang, Johor 86000 | #### E. DESCRIPTION OF THE DEVICE The proposed device, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09 The classification is: Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years. #### F. INDICATIONS FOR USE STATEMENT: A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. {5}------------------------------------------------ #### K172942 #### PAGE NO - 3 #### G. NON-CLINICAL TEST CONCLUSION Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards: ASTM D3577-09:- Standard Specification for Rubber Surgical Gloves. ASTM D 5151-2011:-Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-2011:- Standard Test Method for Residual Powder on Medical Gloves. ASTM D5712-10:-Standard Test Method for the Analysis of Aqueous Extractable Protein in NaturalRubber and Its Products Using the Modified Lowry Method. ASTM D6499-12:-Standard Test Method for the Immunological Measurement of Antigenic Proteinin Natural Rubber and Its Products. ASTM F 1929-2004:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. 1S01137-2: 2013. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose. ISO 10993-7:2008:-Biological evaluation of medical devices -: Ethylene oxide sterilization residuals ISO 11135-1:2007 :- Sterilization of healthcare products -- Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. {6}------------------------------------------------ #### K172942 #### PAGE NO -4 #### H. PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-09 STANDARD SIZES AVAILABLE: - 5'/2, 6, 6'/2, 7, 7'/2, 8, 8'/2, 9 | SL.NO | CRITERIA | SPECIFICATION AS<br>PER ASTMD3577-09<br>STANDARD | AVERAGE VALUE OF<br>SUBJECT DEVICE | WHETHER SUBJECT<br>DEVICE COMPLIED<br>WITH THE<br>ASTMD3577 -09<br>STANDARD | |-------|-------------------------------------------------------|--------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------| | 1 | Length | | | | | | Size 5′/2 | Min 265mm | 281 mm | Yes | | | Size 6 | Min 265mm | 281mm | Yes | | | Size 6′/2 | Min 265mm | 282mm | Yes | | | Size 7 | Min 265mm | 282mm | Yes | | | Size 7′/2 | Min 265mm | 282mm | Yes | | | Size 8 | Min 265mm | 283mm | Yes | | | Size 8′/2 | Min 265mm | 283mm | Yes | | | Size 9 | Min 265mm | 283mm | Yes | | 2 | Width | | | | | | Size 5′/2 | 70+/-6mm | 74mm | Yes | | | Size 6 | 76+/-6mm | 78mm | Yes | | | Size 6′/2 | 83+/-6mm | 84mm | Yes | | | Size 7 | 89+/-6mm | 91mm | Yes | | | Size 7′/2 | 95+/-6mm | 97mm | Yes | | | Size 8 | 102+/-6mm | 103mm | Yes | | | Size 8′/2 | 108+/-6mm | 109mm | Yes | | | Size 9 | 114+/-6mm | 115mm | Yes | | 3 | Finger Thickness<br>(All sizes) | Min 0.10mm | 0.18mm | Yes | | 4 | Palm Thickness<br>(All sizes) | Min 0.10mm | 0.16mm | Yes | | 5 | Cuff Thickness<br>(All sizes) | Min 0.10mm | 0.13mm | Yes | | SL.NO | CRITERIA | SPECIFICATION AS<br>PER ASTMD3577-09<br>STANDARD | AVERAGE VALUE<br>OF SUBJECT<br>DEVICE | WHETHER SUBJECT<br>DEVICE COMPLIED<br>WITH THE ASTMD3577<br>-09 STANDARD | | 6 | Tensile Strength | | | | | | Before aging<br>(All sizes) | 24Mpa minimum | 28.0Mpa | Yes | | | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 18Mpa minimum | 24.0Mpa | Yes | | 7 | Ultimate Elongation | | | | | | Before aging<br>(All sizes) | 750% minimum | 920% | Yes | | | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 560% minimum | 750% | Yes | | 8 | Stress at 500%<br>before ageing<br>(All sizes) | 5.5 MPa Max | 3 Mpa | Yes | | 9 | Pinhole AQL | | | | | | Before aging<br>(All sizes) | Max 1.5 | 1.0 | Yes | | | After aging@<br>70°C for 7 days<br>(All sizes) | Max 1.5 | 1.0 | Yes | {7}------------------------------------------------ # PAGE NO - 5 {8}------------------------------------------------ # K172942 #### PAGE NO - 6 #### I. SUBSTANTIAL EQUIVALENCE COMPARISON #### General Characteristics Comparison a. | Characteristic | Subject device<br>K172942 | Predicate device-1<br>K151114 | Predicate device-2<br>K130450 | Substantially<br>Equivalent<br>(SE) or Not<br>(NSE) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Product Code | KGO | KGO | KGO | SE | | Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | SE | | Class | 1 | 1 | 1 | SE | | Intended Use for<br>Latex Surgeon's<br>Gloves Powder<br>Free, Polymer<br>coated with<br>protein content<br>labeling claim of<br>50 $\mu$ g/dm² or less<br>per glove of<br>extractable<br>protein. | A latex surgeon's glove is a<br>device made of natural rubber<br>intended to be worn by<br>operating room personnel to<br>protect a surgical wound from<br>contamination. | A latex surgeon<br>Surgeons glove is<br>a device made of<br>natural rubber<br>intended to be<br>worn by operating<br>room personnel to<br>protect a surgical<br>wound from<br>contamination | A latex surgeon<br>Surgeons glove is<br>a device made of<br>natural rubber<br>intended to be<br>worn by operating<br>room personnel to<br>protect a surgical<br>wound from<br>contamination - | Substantially<br>equivalent | | Powdered or<br>Powder free | powered free | Powdered, and<br>powered free | powered free | SE | | Classification per<br>ASTMD3577-99 | Type I - gloves compounded<br>primarily from natural rubber<br>latex | Type I - gloves<br>compounded<br>primarily from<br>natural rubber<br>latex | Type I - gloves<br>compounded<br>primarily from<br>natural rubber<br>latex | SE | | Sterilization | ETO/as well as Radiation,<br>SAL- 10-6 | ETO/as well as<br>Radiation,<br>SAL- 10-6 | Radiation<br>SAL: 10-6 | SE | | Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's<br>Requirements | Meet FDA's<br>Requirements | SE | | Special label<br>claim | Protein content labeling claim<br>of 50 $\mu$ g/dm² or less per glove<br>of extractable protein for Latex<br>Surgeon's Gloves<br>Powder<br>Free, Polymer coated | Same | same | SE | | Type of use | Over the counter use | Over the counter<br>use | Over the counter<br>use | SE | {9}------------------------------------------------ # K172942 #### PAGE NO - 7 #### b. Technological Characteristics Comparison | Characteristics | Acceptance criteria of the standard | | | Whether the<br>subject device<br>met the<br>acceptance<br>criteria of the<br>standard | |--------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------| | | Subject device<br>K172942 | Predicate device-1<br>K151114 | Predicate device-2<br>K130450 | | | Dimensions | ASTM D3577-<br>09(published date<br>02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes | | Physical<br>Properties | ASTM D3577-09<br>(published date<br>02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes | | Freedom from<br>Holes | ASTM D3577 and<br>AST M D5151,(published<br>date 08/20/2012) | ASTM D3577 and<br>AST M D5151 | ASTM D3577 and<br>AST M D5151 | Yes | | Powder Content<br>for powdered<br>glove | ASTM D3577 and ASTM<br>D6124,(published date<br>08/20/2012) | ASTM D3577 and<br>ASTM D6124 | ASTM D3577 and<br>ASTM D6124 | Yes | | Powder Content<br>for powder free<br>glove | ASTM D3577 and ASTM<br>D6124,(published date<br>08/20/2012)<br>Powder content < 2<br>mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content < 2<br>mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content <<br>2 mg/Glove | Yes | | Protein Content | ASTM D3577, ASTM<br>D5712-10 and ASTM<br>D6499<br>(published date<br>02/01/2009) | ASTM D3577,<br>ASTM D5712-10<br>and ASTM D6499 | ASTM D3577,<br>ASTM D5712-10<br>and ASTM D6499 | Yes | | Biocompatibility | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | Yes, Non-<br>irritant and Non-<br>Sensitizer | {10}------------------------------------------------ #### K172942 #### PAGE NO - 8 There is no difference with predicate device. #### Substantial equivalence based on non clinical performance data The performance test data of the non clinical tests are the same as mentioned immediately above. #### Substantial equivalence based on clinical performance data. Clinical data was not required for this submission. #### Substantial Equivalence Conclusions The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices identified in this submission (K151114 and K130450).