Iconic Nitrile Glove

{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 Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 11, 2021 Iconic Medicare Sdn Bhd % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main Road, Anna Nagar West Chennai, Tamil Nadu 600040 India Re: K212182 Trade/Device Name: Iconic Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 26, 2021 Received: November 10, 2021 Dear A.C. Thirumaran: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Clarence W. Murray, III, PhD. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K212182 Device Name Iconic Nitrile Glove Indications for Use (Describe) This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. 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}------------------------------------------------ Iconic Medicare Sdn Bhd 510(k) Premarket submission Iconic Nitrile Glove #### 510(K) Summary K212182 #### ICONIC NITRILE GLOVE Preparation Date: 12/10/2021 #### 1. Submitter: Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: No. 1-2,jalan City, Icon City.14000, Bukit Mertajam, Pulau Pinang, Malaysia Telephone No: 6045040588 Email: cctan(@jconic.com.my #### 2. Name of the Device Trade Name / Proprietary Name: Iconic Nitrile Glove Device Common Name: Powder Free Nitrile Examination gloves. Device Classification Name: Polymer Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA #### 3. Official Correspondent Mr.A.C.Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com #### 4. Identification of the Legally Marketed Device: Predicate Device: Meditech Gloves SDN BHD 510k Number: - K210755 Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA {4}------------------------------------------------ #### 5. Device Description The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large. #### 6. Intended use of the Device Iconic Nitrile Glove, a polymer patient examination glove is a disposable device & Non Sterile which is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is for over-the-counter use. {5}------------------------------------------------ | /. Technological characteristics Comparison for the proposed and predicatedences | | | | | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--| | Characteristics<br>Acceptance Criteria | | Subject device:<br>Iconic Nitrile Glove- Blue | Predicate Device | Remarks | | | | | (Small, Medium, Large,<br>X-Large) | Powder Free Nitrile Patient<br>Examination Gloves, Non-<br>Sterile (Blue) | | | | Product Code | LZA | LZA | LZA | same | | | Intended use | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over- the-<br>counter use. | This powder free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. The<br>device is for over- the-<br>counter use. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner. | same | | | Material used | Nitrile compound | Nitrile compound | Nitrile compound | same | | | Colour | N/A | Blue | Blue | same | | | Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same | | | Single use | Single use | Single use | Single use | same | | | Dimensions | Overall Length (mm) Min Meets ASTM D6319-19<br>230mm | | Meets ASTM D6319- 19 | same | | | | Width (±10mm)<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120<br>Thickness at Palm (mm) | Meets ASTM D6319- 19<br>Meets ASTM D6319- 19 | Meets ASTM D6319- 19<br>0.06— 0.09mm | | | | | Min; 0.05 mm<br>Thickness at Finger Tip | Meets ASTM D6319- 19 | 0.07-0.10mm | | | | | (mm) Min 0.05 mm | | | | | | Physical<br>Properties | a.Before Aging<br>(i) Tensile Strength=14 MPa,<br>min.<br>(ii) Ultimate Elongation= 500 %<br>min | Meets ASTM D6319- 19 | Meets ASTM D6319- 19 | same | | ## 7. Technological characteristics Comparison for the proposed and predicatedevices {6}------------------------------------------------ # lconic Medicare Sdn Bhd 510(k) Premarket submission Iconic Nitrile Glove | b. After Accelerated Aging<br>(i) Tensile Strength=14 MPa,<br>min.<br>(ii)Ultimate Elongation= 400 %<br>min | | | |-------------------------------------------------------------------------------------------------------------|--|--| | | | | {7}------------------------------------------------ ## Iconic Medicare Sdn Bhd 510(k) Premarket submission Iconic Nitrile Glove | Freedom from<br>pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM D5151- 19 | Meets ASTM D5151- 19 | same | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------| | Residual<br>Powder | < 2.0 mg/pc | Meets ASTM D6124- 06<br>Result obtained: 0.24 | Meets ASTM D6124- 06 | same | | | ISO 10993-10:2010<br>Biological evaluation of<br>medical devices — Part<br>10: Tests for irritation<br>and skin sensitization | Under the conditions of this<br>study, the test article was a<br>non- irritant. | Under the conditions of this<br>study, the test article was a<br>non- irritant. | same | | Biocompatibility | ISO 10993-10:2010<br>Biological evaluation of<br>medical devices — Part<br>10: Tests for irritation<br>and skin sensitization | Under the conditions of this<br>study, the test article was a<br>non- sensitizer. | Under the conditions of this<br>study, the test article was a<br>non- sensitizer. | same | | | ISO 10993-5:2009<br>Biological evaluation of<br>medical devices - Part<br>5: Tests for in vitro<br>cytotoxicity | Complies with the<br>requirement of this<br>standard | Complies with the<br>requirement of this standard | Same | | | ISO 10993-11:2017<br>Biological evaluation of<br>medical devices — Part<br>11: Tests for systemic<br>toxicity | Not induce systemic<br>toxicity | N/A | same | {8}------------------------------------------------ #### 8. Summary of non-clinical testing results Iconic Nitrile Glove was tested and found in conformance with the following standards: | ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application | |---------------|------------------------------------------------------------------------------------------------| | ASTM D5151-19 | Standard Test Method for detection of Holes in Medical Gloves | | ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves | | ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10 | Biological evaluation on medical device Part 10: Test for irritation and Skin<br>Sensitization | | ISO 10993-11 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | | ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation | | Test<br>Methodology | Purpose | Acceptance<br>Criteria | Average Results | | | | Final<br>status | |---------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------|-------------|-------------|-------------|-----------------| | | Sterility | | SMALL | Medium | Large | X Large | - | | | Freedom from<br>hole - ASTM<br>D5151-19 | AQL 2.5 | Non sterile | Non sterile | Non sterile | Non sterile | Pass | | | Dimensions -<br>width, Length,<br>Thickness | Overall Length<br>(mm) Min<br>230mm. | 234.9 | 246 | 236.5 | 241.0 | Pass | | | | Width (±10mm)<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120 | 84.7 | 97.4 | 106.4 | 114.6 | Pass | | | | Thickness at Palm & fingertip Min: 0.05 mm | | | | | | | | | Palm | 0.10 | 0.06 | 0.08 | 0.09 | Pass | | | | Fingertip | 0.12 | 0.10 | 0.13 | 0.13 | Pass | | | | | a. Before Aging | | | | | | ASTM D6319-<br>19 | Physical<br>properties before<br>aging, after<br>accelerated aging | Tensile<br>Strength=14 MPa,<br>min. | 21.2 | 25 | 18.9 | 18.4 | Pass | | | | Ultimate<br>Elongation= 500<br>% min | 896.3 | 893.8 | 919.7 | 930.9 | Pass | | | | b. After Accelerated Aging | | | | | | | | | Tensile<br>Strength=14 MPa,<br>min. | 23.5 | 26.8 | 22.2 | 19.3 | Pass | | | | Ultimate<br>Elongation= 400<br>% min | 879.2 | 787.9 | 855.3 | 858.6 | Pass | | | Powder-free<br>Residue exceeds<br>maximum limit -<br>ASTM D6124-06 | < 2.0 mg per<br>glove | 0.78 | 0.24 | 0.38 | 0.54 | Pass | | ISO 10993-5 | Test for Invitro<br>cytotoxicity | Cytotoxic<br>Characteristics | Pass | | | | | | ISO 10993-10 | Test for irritation<br>and Skin<br>Sensitization | Non - Skin<br>Sensitized | Pass | | | | | {9}------------------------------------------------ | ISO 10993-11 | Tests for systemic<br>toxicity | Not induce<br>systemic toxicity | Pass | |--------------|--------------------------------|---------------------------------|------| | ISO 10993-23 | Tests for irritation | Non-Irritant | Pass | #### 9. Summary of clinical Performance data Not applicable - Clinical data was not used to assess performance of the subject device. #### 10. Conclusion The Conclusion drawn from the Non-Clinical test demonstrates that the subject device- Iconic Nitrile Glove is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K210755.