Nitrile Patient Examination Gloves, Powder Free

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". September 15, 2022 Lalan Rubbers (Pvt) Ltd Renuka Priyangi Manager - Quality Assurance No.95/B, Zone A, Export Processing Zone, Biyagama Malwana, Western EPZ 11672 Sri Lanka Re: K220697 Trade/Device Name: Nitrile Patient Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 29, 2022 Received: August 26, 2022 Dear Renuka Priyangi: 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. 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 {1}------------------------------------------------ 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, 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) K220697 Device Name Nitrile Patient Examination Gloves, Powder Free Indications for Use (Describe) Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands 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}------------------------------------------------ # 510(k) Summary K220697 #### APPLICANT | Company Name | Lalan Rubbers (Pvt) Ltd | |--------------|------------------------------------------------------------------------------------| | Address | No.95/B, Zone A, Export Processing Zone, Biyagama, Malwana<br>Sri Lanka, EPZ 11672 | #### CONTACT PERSON | Name | Renuka Priyangi | |-------------|-------------------| | Designation | Manager - QA | | Telephone | 0094716852746 | | Fax | 0094114311222 | | Email | qa@lalangroup.com | #### DATE PREPARED September 15, 2022 #### DEVICE | Trade Name | Nitrile Patient Examination Gloves, Powder Free | |----------------------|-------------------------------------------------| | Common Name | Nitrile Patient Examination Gloves | | Classification | Nitrile Patient Examination Gloves | | Product Code | LZA | | Device Class | Class I | | C.F.R. Section | 21 CFR 880.6250 | | Classification Panel | General Hospital | #### LEGALLY MARKETED PREDICATE DEVICE | Product Owner | Primus Gloves Private Limited | |---------------|-----------------------------------| | Trade name | Primus Nitrile Examination Gloves | | 510(k) Number | K143477 | | Device Class | Class I | | Product code | LZA | | | | #### DEVICE DESCRIPTION The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application. #### Characteristic | Sterility | Non Sterile | |-------------------|----------------------------------------| | Material | Nitrile | | Surface treatment | Inner chlorinated outer polymer coated | {4}------------------------------------------------ | Color | Blue | |--------------------|--------------------------------------------| | Geometry | Ambidextrous | | Texture | Full textured | | Cuff end finishing | Beaded | | Usage | Single use & Over-the counter | | Target Population | Adults | | Available sizes | Ex Small, Small , Medium , Large, Ex Large | | Shelf life | 3 Years | ## INDICATIONS FOR USE STATEMENT Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | Predicate Device | Proposed Subject<br>Device | Comparison<br>Result | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Trade name | Primus Nitrile<br>Examination Gloves | Nitrile Patient<br>Examination Gloves,<br>Powder Free | Not<br>applicable | | 510k Number | K143477 | K220697 | Not<br>Applicable | | Product Owner | Primus Gloves Private<br>Limited | Lalan Rubbers (Pvt) Ltd | Not<br>Applicable | | Product Code | LZA | LZA | Same | | Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Regulatory Class | 1 | 1 | Same | | Regulation Name | Patient Examination<br>Glove | Patient Examination<br>Glove | Same | | Classification Panel | General Hospital | General Hospital | Same | | Target Population | Adults | Adults | Same | | Intended Use/<br>Indications for Use | The Nitrile Patient<br>Examination gloves,<br>Powder free, Blue color, is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiners'<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Nitrile Patient<br>Examination Gloves,<br>Powder Free, are<br>intended for medical<br>purposes that are worn<br>on the examiners' hands<br>to prevent contamination<br>between patient and<br>examiner. | Same | | Material<br>Composition | Synthetic nitrile rubber | Synthetic nitrile rubber | Same | | Design | Non-sterile | Non-sterile | Same | | | Single use | Single use | Same | | | Powder-free | Powder-free | Same | {5}------------------------------------------------ | | | Ambidextrous | Ambidextrous | Same | |------------------------------|-------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | | | Beaded cuff | Beaded cuff | Same | | Sterility | | Non-sterile | Non-sterile | Same | | Shelf Life | | 3 years | 3 years | Same | | Performance<br>a. Dimensions | | Meets ASTM D6319<br>requirements | Meets ASTM D6319<br>requirements | Same | | b. Physical Properties | | Meets ASTM D6319<br>requirements | Meets ASTM D6319<br>requirements | Same | | c. Freedom from holes | | Meets ASTM D6319<br>requirements of GI, AQL<br>2.5 | Meets ASTM D6319<br>requirements of GI, AQL<br>2.5 | Same | | d. Powder Residual | | Meets ASTM D6319<br>requirements; Not more<br>than 2.0mg/glove | Meets ASTM D6319<br>requirements; Not more<br>than 2.0mg/glove | Same | | e. Sterility | | Non-sterile | Non-sterile | Same | | Biocompatibility | Skin Irritation | Under the conditions of the<br>study not an irritant | Under the conditions of<br>the study not an irritant | Same | | | Skin<br>Sensitization | Under the conditions of the<br>study not a sensitizer | Under the conditions of<br>the study not a sensitizer | Same | | | In Vitro<br>Cytotoxicity | No data available | Under the conditions of<br>the study for diluted<br>concentrations 12.5% and<br>6.25% are not cytotoxic.<br>Undiluted extract (100%)<br>,diluted concentrations<br>50% & 25% are<br>cytotoxic. | Similar | | | Acute<br>Systemic<br>Toxicity | No data available | Under the conditions of<br>the study no evidence of<br>systemic toxicity | Similar | #### DISCUSSION OF NON-CLINICAL TESTS PERFORMED Non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The test results demonstrated that the proposed subject device complies with the following standards: - ASTM, D6319-19, Standard Specification for Nitrile Examination Gloves for Medical । Application - -ASTM, D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves - ASTM, D5151-19, Standard Test Method for Detection of Holes in Medical Gloves - - ISO, 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices Part 10: -Tests for irritation and skin sensitization - ISO,10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation - ISO,10993-11 Third edition 2017-09, Biological evaluation of medical devices Part 11: Tests for systemic toxicity {6}------------------------------------------------ - ISO,10993-5 Third edition 2009-06-01, Biological evaluation of medical devices Part 5: -Tests for in vitro cytotoxicity - EN, 455-4:2009, Medical gloves for single use Part 4: Requirements and testing for shelf life determination | Characteristics | Standard/Specification | Result Summary | |------------------------------|------------------------|-----------------------------------------------------------------------| | 1. Physical Characteristics: | | | | 1.1 Dimensions | ASTM D6319 | Meets ASTM D6319 requirements for<br>length, palm width and thickness | | Length | Minimum 230mm | Minimum 240mm | | Palm width (mm) | | | | Size - XS | $70 \pm 10$ | $\leq 80$ | | Size - S | $80 \pm 10$ | $85\pm5$ | | Size - M | $95 \pm 10$ | $95\pm5$ | | Size - L | $110\pm 10$ | $105\pm5$ | | Size - XL | $120 \pm 10$ | $\geq 110$ | | Thickness (mm) - single-wall | | | | Finger | minimum 0.05 | Finger - $0.09 \pm 0.01$ | | Palm | minimum 0.05 | Palm - $0.07 \pm 0.01$ | | Cuff | - | Cuff - $0.05 \pm 0.01$ | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Lalan Rubbers. The logo consists of a stylized symbol in blue and green, resembling a curved or flowing shape. To the right of the symbol is the word "LALAN" in bold, dark blue letters. Below "LALAN" is the word "Rubbers" in a smaller, lighter font. | 1.2 Physical<br>Properties | ASTM D6319 | Meets ASTM D6319 requirements for<br>tensile strength and ultimate<br>elongation before and after<br>accelerated aging | |-----------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tensile Strength | | | | Before Aging | minimum 14 MPa | minimum 14 MPa | | After Aging | minimum 14 MPa | minimum 14 MPa | | Ultimate Elongation | | | | Before Aging | minimum 500% | minimum 500% | | After Aging | minimum 400% | minimum 400% | | 2. Freedom from<br>holes | ASTM D6319<br>ASTM D5151 | Meets ASTM D6319 and ASTM D5151<br>requirements of AQL 2.5 | | 3. Powder Residual | ASTM D6319<br>ASTM D6124 | Meets applicable requirement for powder<br>free; ≤ 2 mg per glove | | 4. Biocompatibility | | | | Skin Irritation<br>Test | ISO10993-23:2021 | Under the conditions of the study, not an<br>irritant | | Skin Sensitization Test<br>(GPMT) | ISO 10993-10:2010 | Under the conditions of the study, not a<br>sensitizer | | In Vitro<br>Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, diluted<br>concentrations 12.5% and 6.25% are not<br>cytotoxic. Undiluted extract (100%)<br>,diluted concentrations 50% & 25% are<br>cytotoxic. | | Acute Systemic<br>Toxicity | ISO 10993-11: 2017 | Under the conditions of the study, no<br>evidence of systemic toxicity | ### DISCUSSION OF CLINICAL TESTS PERFORMED Clinical testing is not needed for this device. ## CONCLUSION The conclusions drawn from the non-clinical tests demonstrate that Nitrile Patient Examination Gloves, Powder Free is as safe as effective, and performs as well as or better than the legally marketed predicate device previously cleared under K143477.