Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". May 7, 2021 Meditech Gloves SDN BHD Wan Hassan Assistant Manager - QA/RA PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, Negeri Sembilan 71800 Malaysia Re: K210755 Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 5, 2021 Received: March 15, 2021 Dear Wan Hassan: 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 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 {1}------------------------------------------------ 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, Clarence W. Murray, III, Ph D. Acting 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) K210755 Device Name Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) ### Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <input type="checkbox"/> Residential (Dwelling) CER-WA Category 1 | |-----------------------------------------------------------------------| | <input type="checkbox"/> Care-Type Community Health CER-WA Category 2 | | | 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}------------------------------------------------ #### 1.0 Submitter: | Name: | Dr Effendi Tenang | |------------|---------------------------------------------------------------------------------------------------------------------------------| | Address: | Meditech Gloves Sdn Bhd<br>PT3345, Jalan Permata 1/3, Arab Malaysian Industrial Park,<br>71800 Nilai, Negeri Sembilan, MALAYSIA | | Phone No.: | +60 6 799 7742 | | Fax No.: | +60 6 799 7749 | Date of Summary Prepared: May 4, 2021 #### 2.0 Name of the device: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Common Name: Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) #### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed: Dermagrip Powder Free Blue Nitrile Examination Gloves 510(k): K133168 Regulatory Class I Product Code: LZA #### 4.0 Description of The Device: Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. #### 5.0 Intended Use of the Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. {4}------------------------------------------------ #### 6.0 Comparison of the Technological Characteristics of the Device: The Powder Free Nitrile Examination Gloves, Non-Sterile (Blue) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |-------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | | | PREDICATE<br>BLUE | CURRRENT<br>BLUE | | | 510(k) Number | - | K133168 | K210755 | N/A | | Manufacturer(s) | - | WRP Asia Pacific Sdn Bhd | Meditech Gloves Sdn Bhd | Same | | Material | ASTM D6319-10 | Nitrile | Nitrile | Same | | Color | - | Blue | Blue | Same | | Texture | - | Finger textured | Finger textured | Same | | Physical Properties | ASTM D6319-10 | | | | | Before Aging<br>Tensile Strength :<br>Ultimate Elongation : | | 14MPa min<br>500% min | 14MPa min<br>500% min | Same | | After Aging<br>Tensile Strength :<br>Ultimate Elongation : | | 14MPa min<br>400% min | 14MPa min<br>400% min | Same | | Thickness - Finger<br>- Palm<br>- Cuff | ASTM D6319-19 | 0.07-0.10mm<br>0.07-0.09mm<br>0.06-0.08mm | 0.07- 0.10mm<br>0.06- 0.09mm<br>0.06- 0.08mm | Similar | | Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS | | | | PREDICATE<br>BLUE | CURRRENT<br>BLUE | | | Biocompatibility | Primary Skin Irritation -<br>ISO 10993-10:2010 | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site after<br>(24±2), (48±2) and (72±2)<br>hours. The primary Irritation<br>Index (PII) was "0" | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site after<br>(1±0.1), (24±2), (48±2) and<br>(72±2) hours. The primary<br>Irritation Index (PII) was "0".<br>Also, no mortality after 72<br>hours. The gloves considered<br>negligible. | Similar | | Biocompatibility | Dermal Sensitization- ISO<br>10993-10:2010 | Passes (Not a contact<br>sensitizer)<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 24 hours<br>and 48 hours) in animals<br>treated with the test material<br>and negative control. | Passes (Not a contact<br>sensitizer)<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 0, 24<br>hours and 48 hours) in<br>animals treated with the test<br>material and negative control. | Similar | | Biocompatibility | Cytotoxicity - MEM Elution,<br>ISO 10993-5:2009 | Exhibit severe cytotoxicity<br>reactivity at 100%, 66%, 44%<br>and 30% extract concentration.<br>Slight cytotoxicity reactivity at<br>20% and no cytotoxicity<br>reactivity at 15% extract<br>concentrations. | Exhibit severe cytotoxicity<br>reactivity at 100%, 50%, and<br>25% extract concentration.<br>No cytotoxicity reactivity at<br>12.5%,6.25% and 3.125%<br>extract concentrations. | Similar | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | | | | PREDICATE | CURRENT | | | | | BLUE | BLUE | | | Biocompatibility | Acute Systemic Toxicity,<br>ISO 10993-11:2017 (E) | Not Available | Passes (no adverse biological<br>reaction)<br>No mortality was observed<br>(72±2) hours | Not Available | | Watertight (1000ml) | ASTM D5151-19 | Inspection<br>Level 1, AQL 1.5 | Inspection<br>Level 1, AQL 1.5 | Same | | Intended use | | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between patient<br>and examiner. | A patient examination glove<br>is a disposable device<br>intended for medical purposes<br>that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner. | Same | | Size | Medical Glove Guidance<br>Manual - Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same | | Single Use | Medical Glove Guidance<br>Manual – Labeling | Single use | Single use | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ There are no significant differences between the two products and they are the same or similar in terms of intended use, materials, design, manufacturing methods. #### 7.0 Summary of Non-Clinical Performance Data The performance test data of the non-clinical tests for this powder free nitrile examination gloves is summarized as per below. {8}------------------------------------------------ | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | |------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|---------------|---------|------|--------| | Physical<br>Properties | ASTM D412-16<br>(Standard Test Method<br>for Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the tensile<br>(tension) properties of<br>glove. | Tensile<br>Strength | Min 14<br>MPa | 15.3 | 14.8 | Pass | | | | | Ultimate<br>Elongation | Min 500% | 500 | 460 | Pass | | | | | | Min 400% | | | | | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | | |----------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------|----------------------------------|--------------------------------------------|------| | Dimension | ASTM D3767-<br>03(2020) Standard<br>Practice for Rubber –<br>Measurement of<br>Dimensions | To measure the<br>length, width, and<br>thickness of glove | Length | Min 240mm | Min 240 | Pass | | | | | Width: | | | | | | | | XS | 70 ± 10 mm | Ave = 72 mm | Pass | | | | | S | 80 ± 10 mm | Ave = 84 mm | Pass | | | | | M | 95± 10 mm | Ave = 95 mm | Pass | | | | | L | 110 ± 10 mm | Ave = 102 mm | Pass | | | | | XL | >110 | Ave = 113 mm | Pass | | | | | Thickness | Finger – 0.05mm<br>Palm – 0.05mm | Thickness Finger – 0.10mm<br>Palm – 0.06mm | Pass | | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |----------------|----------|--------------------|---------------------|---------|--------| |----------------|----------|--------------------|---------------------|---------|--------| {9}------------------------------------------------ | Water Tight | ASTM D 5151-19<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | To detect holes that<br>leak water and thereby<br>compromise the<br>usefulness of the glove | Sample Size : 315<br>Inspection Level : GI<br>AQL : 1.5<br>Acceptance No : 10 | This batch sampling is 150,001 to<br>500,000. Hence according to single<br>sampling plan GI, the sample to be<br>drawn is under Code M equivalent<br>to 315 pieces with accept 10 and<br>reject 11.<br>During the test , 6 pieces were<br>found with leaks. Hence it falls<br>within the acceptance criteria. | Pass | |-------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| |-------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |--------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------|--------| | Residual<br>Powder | ASTM D6124-06<br>(2017) Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | To determine the<br>amount of residual<br>powder and non-<br>powder solids found on<br>gloves | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result : 1.5 mg/glove | Pass | {10}------------------------------------------------ #### 8.0 Summary of Clinical Performance Data Not applicable - Clinical data was not used to assess performance of the subject device. #### 9.0 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210775), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Dermagrip Powder Free Blue Nitrile Examination Gloves (K133168).