Iconic Latex Glove

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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. August 25, 2022 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: K221648 Trade/Device Name: Iconic Latex Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: May 20, 2022 Received: June 7, 2022 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 mediation-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. Bifeng Qian, M.D., Ph.D 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) K221648 Device Name Iconic Latex 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. 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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}------------------------------------------------ #### 1.0 Submitter: Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: PMT 798, LINGKARAN CASSIA SELATAN. TAMAN PERINDUSTRIAN BATU KAWAN, 14110 BANDAR CASSIA, PULAU PINANG. MALAYSIA Email: cctan@iconic.com.my Telephone: 60 4 504159 Date of Summary Prepared: 15th March 2022 #### 2.0 Subject Device Identification: Trade Name / Proprietary Name: Iconic Latex Glove Device Common Name: Non-powder Patient Examination gloves. Device Classification Name: Natural Rubber Latex Patient Examination gloves Device Classification: 1 Regulation Number: 21 CFR 880.6250 Product Code: LYY #### 3.0 Official Correspondent Mr. A.C. Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main road, Anna Nagar west, Chennai- 600040, India. Telephone: 91-44-26162670 Email: iasfda16@gmail.com ### 4.0 Identification of the Legally Marketed Device: Predicate Device: Careglove Global SDN BHD 510k Number: - K161833 Device Name: Latex Examination Gloves Powder Free Classification Name: Natural Rubber Latex Patient Examination Gloves Device Classification: 1 Regulation Number: 21 CFR 880.6250 #### 5.0 Device Description The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe. ### 6.0 Indications for Use {4}------------------------------------------------ lconic Latex Glove. 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. ### 7.0 Technological characteristics Comparison for the proposed and predicate devices The Iconic Latex Glove is a Powder Free Latex Examination Glove, Non-sterile, with the following summarized technological characteristics, in comparison to the Predicate device and specifications in ASTM D3578-19. | Characteristics | Acceptance Criteria | Subject device:<br>Iconic Latex Glove<br>(Small, Medium, Large,<br>X-Large) | Predicate Device Latex<br>Examination Gloves<br>Powder Free Careglove<br>Global SDN BHD | Comparison<br>Analysis | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | 510(k) Number | - | K221648 | K161833 | - | | Product Code | LYY | LYY | LYY | same | | Intended use | A powder free<br>patient examination<br>glove is a<br>disposable device<br>intended for<br>medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. The<br>device is for over-<br>the-counter use. | This 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 to<br>prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the- counter use. | A patient examination<br>glove is a disposable<br>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. | same | | Material used | Latex - Natural<br>Rubber | Latex - Natural Rubber | Latex - Natural Rubber | same | | Color | N/A | Natural White | Natural White | same | | Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same | | Single use | Single use | Single use | Single use | same | | | Overall Length<br>(mm) Min 230mm | Meets ASTM D3578-19 | Meets ASTM D3578-19 | | | Dimensions | Width (±10mm)<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120 | Meets ASTM D3578-19 | Meets ASTM D3578-19 | same | | Characteristics | Acceptance Criteria | Subject device:<br>Iconic Latex Glove<br>(Small, Medium, Large,<br>X-Large) | Predicate Device Latex<br>Examination Gloves<br>Powder Free Careglove<br>Global SDN BHD | Comparison<br>Analysis | | Physical<br>Properties | Thickness at Palm<br>(mm) Min; 0.05 mm | Meets ASTM D3578- 19 | 0.06-0.09mm | same | | | Thickness at Finger<br>Tip (mm) Min 0.05<br>mm | Meets ASTM D3578- 19 | 0.07-0.10mm | | | Physical<br>Properties | Before Aging<br>Tensile Strength =<br>18 MPa, min.<br>Ultimate<br>Elongation = 650<br>% min Stress at<br>500 % Elongation<br>(MPa)<br>After Accelerated<br>Aging<br>Tensile Strength<br>=14 MPa, min.<br>Ultimate<br>Elongation = 500<br>% min | Meets ASTM D3578- 19 | Meets ASTM D3578- 19 | same | | Freedom from<br>pinholes | AQL 2.5 Inspection<br>Level G-1 | Meets ASTM D5151- 19 | Meets ASTM D5151- 19 | same | | Residual<br>Powder | < 2.0 mg/pc | Meets ASTM D6124- 06 | Meets ASTM D6124- 06 | same | | Bio-<br>Compatibility | ISO 10993-23:2010<br>Biological<br>evaluation of<br>medical devices:<br>Tests for irritation | Under the conditions of<br>this study, the test article<br>was a non- irritant. | N/A | same | | | ISO 10993-10:2021<br>Biological<br>evaluation of<br>medical devices -<br>Part<br>10: Tests For skin<br>sensitization | Under the conditions of<br>this study, the test article<br>was a non- sensitizer. | N/A | same | | | ISO 10993-5:2009<br>Biological<br>evaluation of<br>medical devices -<br>Part<br>5: Tests for in vitro<br>cytotoxicity | Complies with the<br>requirement of this<br>standard | N/A | same | | Characteristics | Acceptance Criteria | Subject device:<br>Iconic Latex Glove<br>(Small, Medium, Large,<br>X-Large) | Predicate Device Latex<br>Examination Gloves<br>Powder Free Careglove<br>Global SDN BHD | Comparison<br>Analysis | | | ISO 10993-11:2017<br>Biological<br>evaluation of<br>medical devices —<br>Part<br>11: Tests for<br>systemic toxicity | Not induce systemic<br>toxicity | N/A | Same | | Extractable<br>Protein | Water Extractable<br>Protein, Maximum<br>50 µg/dm²<br>ASTM D 5712-<br>15 | Small = 10.3 µg/dm²<br>Medium = 8.7 µg/dm²<br>Large = 9.9 µg/dm²<br>X Large = 8.8 µg/dm² | < 50 µg/dm² | Same | {5}------------------------------------------------ # 510(k) SUMMARY 510(k) No: K221648 {6}------------------------------------------------ # 510(k) SUMMARY 510(k) No: K221648 ## 8.0 Summary of non-clinical testing results lconic Nitrile Glove was tested and found in conformance with the following standards: | ASTM D3578-19 | Standard Specification for Rubber 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 | | ASTM D5712 -15 | Standard Test Method for Analysis of Aqueous Extractable Protein in Latex,<br>Natural Rubber, and Elastomeric Products Using the Modified Lowry Method | | ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10:2021 | Biological evaluation on medical device Part 10: Test for Skin Sensitization | | ISO 10993-11:2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | | ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation | | Test<br>Methodology | Purpose | Acceptance<br>Criteria | Average Results | | | | Final<br>Results | |---------------------|--------------------------------------------|---------------------------------------------------------------------------|-----------------|-------------|-------------|-------------|------------------| | | | | SMALL | Medium | Large | X Large | | | | Sterility | - | Non sterile | Non sterile | Non sterile | Non sterile | - | | ASTM D3578-<br>19 | Freedom from<br>hole - ASTM<br>D5151-19 | AQL 2.5 | Pass | Pass | Pass | Pass | Pass | | | | Overall Length<br>(mm) Min<br>230mm. | 230.8 | 240.5 | 237.5 | 236.8 | Pass | | | Dimension - width,<br>Length,<br>Thickness | Width (±10mm)<br>Small - 80<br>Medium - 95<br>Large -111<br>X-large - 120 | 83 | 96 | 108.4 | 118.7 | Pass | | | | Thickness at Palm & fingertip Min: 0.08 mm | | | | | | {7}------------------------------------------------ ## 510(k) SUMMARY 510(k) No: K221648 | Test<br>Methodology | Purpose | Acceptance<br>Criteria | Average Results | | | | Final | |---------------------|--------------------------------------------------------------------|--------------------------------------|-----------------|--------|--------|---------|---------| | | | | SMALL | Medium | Large | X Large | Results | | | | Palm | 0.14 | 0.13 | 0.12 | 0.14 | Pass | | | | Fingertip | 0.10 | 0.10 | 0.09 | 0.14 | Pass | | | | a. Before Aging | | | | | | | | | Tensile<br>Strength=18<br>MPa, min. | 20.8 | 23.4 | 21.4 | 20.7 | Pass | | | | Ultimate<br>Elongation=<br>650% min | 1018.7 | 878.9 | 1127.9 | 1097.6 | Pass | | | Physical<br>properties before<br>aging, after<br>accelerated aging | Stress at 500%<br>Elongation | 3.3 | 3.9 | 3.7 | 3.3 | Pass | | | | b. After Accelerated Aging | | | | | | | | | Tensile<br>Strength=14<br>MPa, min. | 15.3 | 17.3 | 16.9 | 17.4 | Pass | | | | Ultimate<br>Elongation= 500<br>% min | 856.4 | 890.8 | 1077.3 | 956.8 | Pass | | | Powder-free<br>Residue exceeds<br>maximum limit -<br>ASTM D6124-06 | < 2.0 mg per<br>glove | 0.12 | 0.26 | 0.38 | 0.18 | Pass | | | Extractable<br>Protein content | $50 µg/dm2$ | 10.3 | 8.7 | 9.6 | 8.8 | 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 | | ISO 10993-11 | Tests for systemic<br>toxicity | Not induce<br>systemic toxicity | | | | | Pass | | ISO 10993-23 | Tests for irritation | Non-Irritant | | | | | Pass | ### 9.0 Summary of clinical Performance data Not applicable - Clinical data was not used to assess performance of the subject device. ### 10.0Conclusion The Conclusion drawn from the Non-Clinical test demonstrates that the subject device- Iconic Latex Glove is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K161833.