Sterile Latex Surgical Gloves, Powder Free

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it. July 13, 2018 Sanrea Healthcare Products Pvt Ltd Jose M Manager QA & RA Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, 678 621 In Re: K171550 Trade/Device Name: Sterile Latex Surgical Gloves, Powderfree Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: June 8, 2018 Received: June 12, 2018 Dear Jose M: 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 (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. 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 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, ### Elizabeth F. Claverie -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) K171550 Device Name STERILE LATEX SURGICAL GLOVES, POWDER FREE Indications for Use (Describe) The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is 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) | 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}------------------------------------------------ ### 1.0 SUBMITTER | 1.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD | |--------------------|---|----------------------------------------------------------------------------------------------------------------------| | 1.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 | | 1.3 Telephone | : | + 91-491-2970145 | | 1.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,<br>qa@sanrea.com | | 1.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER QA & RA | ### 2.0 OFFICIAL CORRESPONDENT | 2.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD | |----------------------|---|----------------------------------------------------------------------------------------------------------------------| | 2.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 | | 2.3 Telephone | : | + 91-491 -2970145 | | 2.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,<br>qa@sanrea.com | | 2.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER QA & RA | | 3.0 PREPARATION DATE | : | 05TH July 2018 | #### IDENTIFICATION OF THE SUBJECT DEVICE 4.0 {4}------------------------------------------------ | 4.1 Device Name | : STERILE LATEX SURGICAL GLOVES, POWDER FREE | |---------------------------|-----------------------------------------------------------------------------------| | 4.2 Trade Name | : SANCARE STERILE LATEX SURGICAL GLOVES,<br>GLOVTEK STERILE LATEX SURGICAL GLOVES | | 4.3 Common Name | : SURGEON'S GLOVES | | 4.4 Classification | : SURGEON'S GLOVES | | 4.5 Class | : CLASS I | | 4.6 CFR Regulation Number | : 21 CFR 878.4460 | | 4.7 Product Code | : KGO | #### 5.0 IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE | 5.1 Device Name | : | Powder free Sterile Latex Surgical Gloves, Yellow Color | |---------------------------|---|---------------------------------------------------------------------------------------------------| | 5.2 510(k) Number | : | K140988 | | 5.3 Company | : | M/S. Hebei HongSen Plastic Technology Co. Ltd<br>853 Dorchester Ln Unitb<br>New Milford, NJ 07646 | | 5.4 Device Description | : | Powder free Sterile Latex Surgical Gloves, Yellow Color | | 5.5 Classification | : | SURGEON'S GLOVES | | 5.6 Class | : | CLASS I | | 5.7 CFR Regulation Number | : | 21 CFR 878.4460 | | 5.8 Product Code | : | KGO | | 5.9 Classification Panel | : | General Hospital | {5}------------------------------------------------ #### DESCRIPTION OF THE DEVICE 6.0 The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use. #### 7.0 INDICATIONS FOR USE The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. #### 8.0 TECHNOLOGICAL CHARACTERISTICS COMPARISON | Characteristics | PREDICATE - 510(K) :<br>K140988 | SUBJECT DEVICE : | Comparison | | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Manufacturer | M/S. Hebei HongSen Plastic<br>Technology Co. Ltd<br>853 Dorchester Ln Unitb<br>New Milford, NJ 07646 | SANREA HEALTHCARE<br>PRODUCTS PVT LTD. Plot # P-<br>56, Pearl Road, Kinfra Integrated<br>Industrial & Textile Park,<br>Kanjikode, Palakkad, Kerala, India<br>- 678 621 | - | | | Product Name | Powder free Sterile Latex<br>Surgical Gloves, Yellow Color | Sterile Latex Surgical Gloves,<br>Powder free | Similar | | | Intended Use | Intended to be worn by<br>operating room personnel to<br>protect a surgical wound from<br>contamination. | Intended for medical purposes<br>that is worn by operating room<br>personnel to protect a surgical<br>wound from contamination. | Same | | | Indication for<br>use | The powder free sterile latex<br>surgical glove, yellow color<br>(Brand Name: Titanfine), is a<br>disposable device made of | The Sterile Latex Surgical<br>Gloves, Powder free, is a<br>disposable device made of<br>natural rubber, intended for | Similar | | | | natural rubber intended to be<br>worn by operating room<br>personnel to protect a surgical<br>wound from contamination. | medical purposes that is worn by<br>operating room personnel to<br>protect a surgical wound from<br>contamination. | | | | Description | Sterile Powder free, surgical<br>gloves are made of natural<br>rubber latex. The gloves are<br>provided in Sizes 6.0, 6.5, 7.0,<br>7.5, 8.0, 8.5 and 9.0 | Sterile Powder free , surgical<br>gloves are made of natural rubber<br>latex. The gloves are provided in<br>Sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5<br>and 9.0 | Same | | | Presentation | Sterile gloves are provided in<br>pouches | Sterile gloves are provided in<br>pouches | Similar | | | Material | Natural Rubber Latex | Natural Rubber Latex | Same | | | Color | Yellow Color | Natural (No color is added) | Different | | | Non-sterile or<br>sterile | Sterile | Sterile | Same | | | Single Use | Yes | Yes | Same | | | Anatomic | Yes | Yes | Same | | | Dimensions | Meets ASTM D3577-09 -<br>Overall length min 265 mm<br>,width varies from 76 mm for<br>6.0 size to 114 mm for 9.0 size,<br>thickness in cuff, finger and<br>palm has a minimum 0.10mm | Meets ASTM D3577 - 09<br>Dimension for size 7.5 :<br>Length : 300mm<br>Width : 95mm<br>Thickness - Cuff : 0.14mm, Palm :<br>0.19mm, Finger : 0.22mm | Similar | | | Tensile<br>Strength | Meets ASTM D3577 -09 and<br>ASTM D412, D573. Tensile<br>strength 24 Mpa min for before<br>aging and 18 Mpa min for after<br>aging. Aging done at 70 $\pm$ 2 deg<br>C for 166 $\pm$ 2 hrs or 100 $\pm$ 2deg C | Meets ASTM D3577 -09 and<br>ASTM D412, D573.<br>Results for size 7.5 :<br>Tensile strength<br>(Before Ageing): 31.22 MPa<br>Tensile strength | Similar | | | | for 22±0.3 hrs | (After Ageing): 24.43 MPa | | | | Ultimate<br>Elongation | Meets ASTM D 3577-09 -<br>Ultimate elongation 750% min<br>for before aging and 560 % min<br>for after aging. Aging done at<br>70 ±2 deg C for 166±2 hrs or<br>100±2deg C for 22±0.3hrs | Meets ASTM D 3577-09 Results<br>for size 7.5 :<br>Ultimate Elongation<br>(Before Ageing) : 843.09 %<br>Ultimate Elongation<br>(After Ageing) : 762.28 % | Similar | | | | Freedom from<br>pinholes | Meets ASTM D 5151 -06 and<br>ASTM D3577 – 09 | Meets ASTM D 5151 -06 (2011)<br>and ASTM D3577- 09<br>Results for size 7.5 :<br>Inspection level/AQL :<br>ISO 2859-1 / G1 / AQL 1.5<br>Lot Size : 35001 – 150000 pair<br>Sample size : 200 pair<br>Holes found : 0 holes<br>Accept/Reject : 10/11 | Similar | | | Residual Powder<br>Content | Meets ASTM D 6124-06(2011) | Meets ASTM D 6124-06(2011)<br>Result for size 7.5 :<br>Powder content : 0.9mg/glove | Similar | | | Residual<br>Protein Content | Meets ASTM D 5712 | Meets ASTM D 5712<br>Result for size 7.5 :<br>Protein Content : 25.56 µg/ dm2 | Similar | | | Biocompatibility<br>Tests -<br>ISO 10993-10 | Under the conditions of the<br>study the device is not an<br>irritant | Under the conditions of the study<br>the device is not an irritant | Same | | Under the conditions of the<br>study the device is not a<br>sensitizer | | Under the conditions of the study<br>the device is not a sensitizer | Same | | | Sterility | Sterile | Sterile | Same | | | Mode of<br>Sterilization | Irradiation | EO Sterilization | Different | | | Labeling | * Powder free<br>* Latex Surgical Glove<br>* Sterile<br>* Single use only | * Powder free<br>* Latex Surgical Glove<br>* Sterile<br>* Single use only | Identical | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | * Anatomic | * Anatomic | |---------------------|---------------------| | * Manufactured for | * Manufactured for | | * Lot No | * Lot No | | * Intended use | * Intended use | | * Quantity | * Quantity | | * Country of origin | * Country of origin | The above table shows similarities and differences of the performance between the subject device and the predicate device. There are only two minor differences between the subject device and the predicate device. One of the differences is that the predicate device has yellow color, while our device in submission is natural in color. The second difference is that the subject device is sterilized by EO sterilization where as the predicate device is sterilized by irradiation method. These minor differences do not impact the intended use, safety and performance of the device. #### SUMMARY OF NON-CLINICAL TESTING 9.0 There is no difference in technological characteristics compared to the predicate device. Gloves are made from Latex compound, which is Sterile and Powder free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below, | Characteristics | Standards | Performance of<br>Sterile Latex Surgical<br>Gloves, Powder free | |----------------------------------|----------------------------------------|-----------------------------------------------------------------| | Freedom from<br>Holes | ASTM D3577-09 / ASTM D5151-06 | Meets | | Dimensions | ASTM D3577-09 | Meets | | Physical Properties | ASTM D3577-09 / ASTM D412-06 | Meets | | Powder-free<br>residue | ASTM D6124-06 | Meets | | Bio-compatibility | Primary skin irritation - ISO 10993-10 | Non-irritant | | | Skin Sensitization - ISO 10993-10 | Non-sensitizer | | Expiration dating/<br>Shelf life | ASTM D7160-05 | Three years | | Sterilization | ISO 11135-2014(E) | Meets | {9}------------------------------------------------ | | Sterilization of healthcare products - Ethylene<br>Oxide - Requirements for the development,<br>validation and routine control of a sterilization<br>process for medical devices | | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | | ISO 10993-07:2008<br>Biological evaluation of medical devices- Part 7:<br>Ethylene oxide sterilization residuals<br>Maximum limit of EO Residue :<br>0.0025mg/device | Meets | | EO Residue | | | | | ISO 10993-07:2008<br>Biological evaluation of medical devices- Part 7:<br>Ethylene oxide sterilization residuals<br>Maximum limit of ECH Residue :<br>0.0025mg/device | Meets | | ECH Residue | | | | | ISO 11737 -2<br>Sterilization of Medical devices-Microbiological<br>methods Part 2: Test of sterility performed in the<br>definition , validation and maintenance of<br>sterilization process | Sterile | | Sterility | | | ### Performance data of gloves based on ASTM D3577-09 and FDA 1000ml water leak test | ASTM D3577 - 09 and FDA 1000 ml water leak test | | | | | | |-------------------------------------------------|-----------------------------------|--------------------------------------|---------------------------------------------|--------------------------------------------------|--------| | Characteristics | Test | Test standard | Sampling plan<br>/Inspection<br>level / AQL | Sterile Latex<br>Surgical Gloves,<br>Powder free | Result | | Freedom from<br>Pin holes | FDA 1000 ml<br>water leak<br>test | ASTM D5151 -06<br>(Re-approved 2011) | ISO 2859-1 /<br>G1/AQL 2.5 | PASS | PASS | | | Length | ASTM D3577 -09 | ISO 2859-1 /<br>S2/AQL 4.0 | > 265 mm | PASS | {10}------------------------------------------------ | Dimensions | Width | ASTM D3577-09 | ISO 2859-1 /<br>S2/AQL 4.0 | 76±6 mm to 114±6<br>mm (sizes 6.0 to 9.0) | PASS | |------------------------|-------------------------------|------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------|------| | | Thickness | ASTM D3577-09 | ISO 2859-1 /<br>S2/AQL 4.0 | > 0.10 mm<br>(Cuff, palm&<br>finger) | PASS | | Physical<br>properties | Before aging | ASTM D3577-09<br>and ASTM D412-06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 24 Mpa | PASS | | | | | | Ultimate Elongation<br>: >750% | PASS | | | After<br>Accelerated<br>aging | ASTM D3577-09<br>and ASTM D573-04 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 18 Mpa<br>Ultimate Elongation<br>: > 560% | PASS | | Powder-free<br>residue | Powder-free<br>residue | ASTM D3577-09 and<br>ASTM D6124-06 | N=5 | Less than 2 mg per<br>glove | PASS | | Biocompatibility | Primary skin<br>irritation | ISO 10993 -10 | Under the conditions of the study the<br>device is not an irritant | | PASS | | | Skin<br>Sensitization | ISO 10993 -10 | Under the conditions of the study the<br>device is not a sensitizer | | PASS | | Sterility | Sterility | ISO-11737-2 | Sterile | | PASS | ### 10.0 CONCLUSION Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed predicate device.