Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black

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April 11, 2022 AAMedix Glove Sdn Bhd Annette Schaps Regulatory Consultant Unit 19D, Level 19, No.16, Persiaran Setia Dagang Bander Setia Alam, 40170 Shah Alam Selanger Darul Ehsan, 40170 Malaysia Re: K220121 Trade/Device Name: Non Sterile Nitrile Powder Free Examination Gloves - Blue,Green, and Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 13, 2022 Received: January 18, 2022 Dear Annette Schaps: 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, 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K220121 Device Name NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES - BLUE, GREEN AND BLACK Indications for Use (Describe) A powder-free 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) 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}------------------------------------------------ # AAMedix Glove Sdn Bhd NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES – BLUE, GREEN AND BLACK # 510(K) Summary ## 510K SUMMARY Date of Summary Prepared: March 23, 2022 510K Number: K220121 - 1. Applicant : AAMedix Glove Sdn Bhd | Address | : Unit 19D, Level 19 | |---------|---------------------------------------| | | No. 16 Persiaran Setia Dagang | | | Bandar Setia Alam | | | 40170 Shah Alam, Selanger Darul Ehsan | | | MALAYSIA | | Tel | : 03-33592650 | | Fax | : 03-33592657 | | E-mails | : anson@aamedix-glove.com | Official Correspondence: Annette Schaps - 2. Device Name: Non Sterile Nitrile Powder Free Examination Gloves Blue, Green And Black color. Trade Name: Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color. Common Name: Nitrile Examination Gloves {4}------------------------------------------------ #### 3. Regulatory Information | Classification Name | Nitrile Powder Free Examination Gloves | |---------------------|----------------------------------------| | Classification | Class I | | Product Code | LZA | | Regulation Number | 21 CFR 880.6250 | #### 4. Predicate Device | 510K Number | : K143289- YTY Industry (Manjung) Sdn. Bhd. | |-------------|--------------------------------------------------------------------------------------------------| | Device Name | : Non Sterile, Powder Free Nitrile Examination Gloves -<br>Orange, Green, Blue and Violet Color. | #### 5. Intended Use A powder-free 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. #### 6. Description The Powder Free Nitrile Examination Gloves are non sterile, single use, and disposable. These gloves are available in Blue, Green, and Black colors. This device is to protect the examiner and prevent contamination between patient and the examiner when properly worn. The sizes of the gloves are Small, Medium, Large and X-Large. Non Sterile Nitrile Powder Free Examination Gloves meet all current specifications listed under ASTM Specifications D6319. {5}------------------------------------------------ | Summary of Comparison and Technological Characteristic | | | | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Table 1 - General Comparison | | | | | | SUBJECT DEVICE:<br>K220121 | PREDICATE DEVICE:<br>K143289 | Comparison | | Company Name | AAMedix Glove Sdn Bhd | YTY INDUSTRY<br>(MANJUNG) SDN. BHD | | | Product Name | Non Sterile, Powder Free<br>Nitrile Examination<br>Gloves-BLUE, GREEN AND<br>BLACK | Non Sterile, Powder Free<br>Nitrile Examination<br>Gloves-Orange, Green,<br>Blue and Violet Color | | | Available Colors | Blue, Green and Black | Blue, Green and Others | Similar | | Available Sizes | Small, Medium, Large and<br>X-Large | Not specified but data<br>provided on Medium | Similar | | Indications for 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. | A patient examination<br>gloves is a disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Similar | | MATERIALS | Carboxylated Butadiene<br>Acrylonitrile as base<br>material | Carboxylated Butadiene<br>Acrylonitrile as base<br>material | Same | | DIMENSIONS | Meets ASTM D6319<br>Criteria | Meets ASTM D6319<br>Criteria | Same | | PHYSICAL<br>PROPERTIES | Meets ASTM D6319<br>Criteria | Meets ASTM D6319<br>Criteria | Same | | FREEDOM FROM<br>HOLES/Watertight | Meets ASTM<br>D6319/ASTM D5151<br>Criteria | Meets ASTM D5151<br>Criteria | Same | | POWDER<br>FREE/Residual Powder | Meets ASTM D6319<br>Criteria | Meets ASTM D6319<br>Criteria | Same | | BIOCOMPATABILITY | Per ISO 10993-10: Non-<br>irritant (Response<br>Category is Negligible)<br>and Non-sensitizer (No<br>sensitization)<br><br>Per ISO 10993-11: Acute<br>Systemic Toxicity; No<br>toxic effects | Per ISO 10993-10: Non-<br>irritant and<br>Non-sensitizer | Same | | Product Common<br>Name | Non sterile Nitrile Powder<br>Free Examination Gloves | Non sterile Nitrile Powder<br>Free Examination Gloves | Same | | Product Code/Class | LZA | LZA | Same | | | Class I<br>(21 CFR 880.6250) | Class I<br>(21 CFR 880.6250) | | | Sterility/Use | Non-Sterile/Single Use | Non-Sterile/Single Use | Same | | OTC Use | Yes | Yes | Same | AAMedix Glove/40170 Shah Alam, Selangor Darul Ehsa, Malaysia {6}------------------------------------------------ | Table 2 Specifications and Performance Test Results Comparison | | | | | |----------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------|---------------------| | | SUBJECT DEVICE:<br>K220121<br>AAMedix Glove<br>Sdn Bhd | PREDICATE DEVICE:<br>K143289<br>YTY INDUSTRY<br>(MANJUNG) SDN.<br>BHD | Comparison | | | Glove Color/Size | BLUE/Medium | BLUE/Medium | | | | DIMENSION | ASTM D6319<br>Accept Criteria | | | | | Overall Length | 230 mm<br>Minimum | 240-246 mm | 240-250 mm | Same | | Width | 95 +/-10 mm | 95-98 mm | 95-99 mm | Same | | Palm Thickness | 0.05 mm<br>Minimum | 0.06-0.06 mm | 0.05-0.06 mm | Same | | Finger thickness | 0.05 mm<br>Minimum | 0.09-0.10 mm | 0.09-0.10 mm | Same | | PHYSICAL PROPERTIES | | | | | | Tensile Strength (before aging) | 14 MPa,<br>Minimum | 25.9-32.0 MPa | 28.46-33.44 MPa | Same | | Tensile Strength (after aging) | 14 MPa,<br>Minimum | 25.4-34.0 MPa | 29.76-34.18 MPa | Same | | Ultimate Elongation (before aging) | 500 %<br>Minimum | 500-540 % | 520-580 % | Same | | Ultimate Elongation (after aging) | 400 %<br>Minimum | 480-520 % | 440-520 % | Same | | FREEDOM FROM<br>HOLES/Watertight | Per ASTM<br>D5151-06<br>(2011) | Holes Found: 0 | Holes found: 0<br>(Accept 1, Reject 7) | Same | | Pinhole AQL | Inspection<br>Level G-1;<br>AQL=2.5 | Inspection Level G-<br>1; AQL=2.5 | Inspection Level G-<br>1; AQL=2.5 | Same | | POWDER<br>FREE/Residual<br>Powder | Residue limit<br>of 2.0<br>mg/glove | 0.70 mg/glove | 0.20 mg/glove | Same | | | ASTM D6319<br>Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | | DIMENSIONS | | | | | | Overall Length | | | | | | -Small | 220 mm minimum | Pass (242-253 mm) | Pass (237-243 mm) | Pass (239-248 mm) | | -Medium | 230 mm minimum | Pass (240-246 mm) | Pass (240-247 mm) | Pass (244-251 mm) | | -Large | 230 mm minimum | Pass (245-255 mm) | Pass (240-247 mm) | Pass (243-251 mm) | | -X large | 230 mm minimum | Pass (243-253 mm) | Pass (240-250 mm) | Pass (241-277 mm) | | Width | | | | | | -Small | 80 +/-10 mm | Pass (85-87 mm) | Pass (86-88 mm) | Pass (85-86 mm) | | -Medium | 95 +/-10 mm | Pass (95-98 mm) | Pass (95-96 mm) | Pass (95-97 mm) | | -Large | 110 +/-10 mm | Pass (106-109 mm) | Pass (106-106 mm) | Pass (105-106 mm) | | -X large | 120 +/-10 mm | Pass (113-115 mm) | Pass (114-116 mm) | Pass (115-115 mm) | | Palm Thickness | | | | | | -Small | 0.05 mm<br>minimum | Pass (0.06-0.07 mm) | Pass (0.12-0.14 mm) | Pass (0.07-0.08 mm) | | -Medium | 0.05 mm<br>minimum | Pass (0.06-0.06 mm) | Pass (0.13-0.13 mm) | Pass (0.07-0.07 mm) | | -Large | 0.05 mm<br>minimum | Pass (0.05-0.07 mm) | Pass (0.11-0.13 mm) | Pass (0.07-0.07 mm) | | -X large | 0.05 mm<br>minimum | Pass (0.06-0.06 mm) | Pass (0.12-0.13 mm) | Pass (0.06-0.07 mm) | | Finger thickness | | | | | | -Small | 0.05 mm<br>minimum | Pass (0.09-0.11 mm) | Pass (0.15-0.17 mm) | Pass (0.11-0.13 mm) | | -Medium | 0.05 mm<br>minimum | Pass (0.09-0.10 mm) | Pass (0.15-0.18 mm) | Pass (0.11-0.13 mm) | | -Large | 0.05 mm<br>minimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.13 mm) | | -X large | 0.05 mm<br>minimum | Pass (0.10-0.11 mm) | Pass (0.15-0.16 mm) | Pass (0.11-0.14 mm) | AAMedix Glove/40170 Shah Alam, Selangor Darul Ehsa, Malaysia {7}------------------------------------------------ ## Summary of Nonclinical Testing: ## Table 3 Summary of Device Specifications and Performance Results {8}------------------------------------------------ | | ASTM D6319<br>Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |---------------------|------------------------------------|----------------------|----------------------|----------------------| | PHYSICAL PROPERTIES | | | | | | | Tensile Strength (Before Aging) | | | | | -Small | 14 MPa minimum | Pass (25.2-31.9 MPa) | Pass (24.1-34.1 MPa) | Pass (33.5-41.2 MPa) | | -Medium | 14 MPa minimum | Pass (25.9-32.0 MPa) | Pass (25.9-32.0 MPa) | Pass (34.3-46.5 MPa) | | -Large | 14 MPa minimum | Pass (23.9-34.3 MPa) | Pass (21.2-28.8 MPa) | Pass (31.6-42.2 MPa) | | -X large | 14 MPa minimum | Pass (28.2-39.2 MPa) | Pass (19.6-29.9 MPa) | Pass (25.2-43.5 MPa) | | | Tensile Strength (After Aging) | | | | | -Small | 14 MPa minimum | Pass (25.6-34.9 MPa) | Pass (24.4-38.1 MPa) | Pass (25.7-43.5 MPa) | | -Medium | 14 MPa minimum | Pass (25.4-34.0 MPa) | Pass (24.8-32.3 MPa) | Pass (34.7-45.8 MPa) | | -Large | 14 MPa minimum | Pass (24.0-37.4 MPa) | Pass (20.7-33.9 MPa) | Pass (35.1-43.0 MPa) | | -X large | 14 MPa minimum | Pass (33.2-40.2 MPa) | Pass (21.6-32.1 MPa) | Pass (24.7-44.8 MPa) | | | Ultimate Elongation (Before Aging) | | | | | -Small | 500% minimum | Pass (500-540%) | Pass (500-580%) | Pass (540-600%) | | -Medium | 500% minimum | Pass (500-540%) | Pass (500-560%) | Pass (520-600%) | | -Large | 500% minimum | Pass (500-560%) | Pass (500-580%) | Pass (520-600%) | | -X large | 500% minimum | Pass (500-560%) | Pass (540-580%) | Pass (460-540%) | | | Ultimate Elongation (After Aging) | | | | | -Small | 400% minimum | Pass (480-520%) | Pass (460-540%) | Pass (540-580%) | | -Medium | 400% minimum | Pass (480-520%) | Pass (460-540%) | Pass (520-600%) | | -Large | 400% minimum | Pass (480-520%) | Pass (480-560%) | Pass (520-560%) | | -X large | 400% minimum | Pass (480-520%) | Pass (500-560%) | Pass (440-520%) | | | ASTM D6319 Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |-----------------------------------------|-------------------------------|----------------|----------------|----------------| | FREEDOM FROM HOLES (Pinhole Inspection) | | | | | | -Small | AQL=2.5; Accept on 10 (n=200) | Pass (Found=1) | Pass (Found=0) | Pass (Found=2) | | -Medium | AQL=2.5; Accept on 7 (n=200) | Pass (Found=0) | Pass (Found=0) | Pass (Found=0) | | -Large | AQL=2.5; Accept on 10 (n=200) | Pass (Found=1) | Pass (Found=1) | Pass (Found=0) | | -X Large | AQL=2.5; Accept on 10 (n=200) | Pass (Found=0) | Pass (Found=6) | Pass (Found=1) | | | ASTM D6319<br>Requirement | BLUE Gloves | GREEN Gloves | BLACK Gloves | |----------|-----------------------------------|--------------------------------------|--------------------------------------|--------------------------------------| | | POWDER FREE/Powder Content | | | | | -Small | does not exceed 2<br>mg per glove | Pass (Average: 0.36<br>mg per glove) | Pass (Average: 0.18<br>mg per glove) | Pass (Average: 0.04<br>mg per glove) | | -Medium | Does not exceed<br>2 mg per glove | Pass (Average: 0.70<br>mg per glove) | Pass (Average: 0.10<br>mg per glove) | Pass (Average: 0.06<br>mg per glove) | | -Large | Does not exceed<br>2 mg per glove | Pass (Average: 0.30<br>mg per glove) | Pass (Average: 0.16<br>mg per glove) | Pass (Average: 0.04<br>mg per glove) | | -X Large | Does not exceed<br>2 mg per glove | Pass (Average: 1.02<br>mg per glove) | Pass (Average: 0.24<br>mg per glove) | Pass (Average: 0.10<br>mg per glove) | AAMedix Glove/40170 Shah Alam, Selangor Darul Ehsa, Malaysia {9}------------------------------------------------ #### 7. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the device, AAMedix Glove Sdn Bhd NON STERILE NITRILE POWDER FREE EXAMINATION GLOVES – BLUE, GREEN AND BLACK , is as safe, as effective, and performs as well as or better than the legally marketed device, YTY INDUSTRY (MANJUNG) SDN. BHD Non Sterile, Powder Free Nitrile Examination Gloves- Orange, Green, Blue and Violet Color (cleared per 510(K) K143289).