Sterile Latex Surgical Glove, Powder Free

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 30, 2019 Careglove Global Sdn Bhd Lim Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, 70450 My # Re: K190241 Trade/Device Name: Sterile Latex Surgical Glove, Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: November 8, 2019 Received: November 12, 2019 # Dear Lim Shyan: 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 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, For Elizabeth Claverie, M.S. Assistant Director for THT4B2 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 510(k) Number (if known) K190241 Device Name STERILE LATEX SURGICAL GLOVES, POWDER FREE Indications for Use (Describe) A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. 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. 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FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large, blue, sans-serif font. Below that, the word "GLOVE" is in a smaller, yellow, sans-serif font. In the middle of the word "GLOVE" is a blue circle with a yellow hand in the center. Below that, the words "CAREPLUS-DESCARPACK" are in a small, black, sans-serif font. # OVE GLO orong Senawang 3/2, Off Jalan Senaw vang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. 82377, 60-6-6788377 Fax: 60-6-6785377 @careelove.com # K190241 ### 510(K) SUMMARY #### CAREGLOVE GLOBAL SDN BHD Applicant: - Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. - Fax No. (60) 66785377 Phone No. (60) 6 6782377 Contact Person: Lim Kwee Shyan Summary Preparation Date: 23rd December, 2019 #### Device Information | Trade Name: | STERILE LATEX SURGICAL GLOVES, POWDER FREE | |----------------------|--------------------------------------------| | Common Name: | STERILE LATEX SURGICAL GLOVES, POWDER FREE | | Classification Name: | Surgeon's Gloves | | Product Code: | KGO | | Regulation: | 21 CFR 878.4460 | | Device Class: | I | #### Predicate device Device Name: STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) Company name: SUPERMAX GLOVE MANUFACTURING SDN BHD 510(K) Number: K014230 ### Device Description The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. #### Indication for Use A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "CARE GLOVE" in a stacked format. The word "CARE" is in a larger, blue font on top, while "GLOVE" is in a smaller, yellow font below it. A hand graphic is placed within the word "GLOVE". The text "CAREPLUS-DESCARPACK" is at the bottom in a smaller, sans-serif font. # CAREGLOVE GLOBAL S Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com ### Summary of the Technological Characteristics of the Device Table 1: Comparison of the Technological Characteristics of the Subject and Predicate Device. | Characteristic | Standard | Specification | Subject Device<br>Sterile Latex<br>Surgical Powder<br>Free<br>K190241 | Legally Marketed<br>Predicate Device<br>K014230 | Remark | |-------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product Code | - | - | KGO | KGO | Same | | Indication for Use<br>Statement | - | - | A sterile latex<br>surgical glove,<br>powder free is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>by operating room<br>personnel to protect<br>a surgical wound<br>from contamination. | A sterile latex surgical<br>glove, powder free is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | Same | | Design | - | - | Powder Free, Sterile,<br>Hand Specific,<br>Beaded Cuff | Powder Free, Sterile,<br>Hand Specific, Beaded<br>Cuff | Same | | Construction | - | - | Hand Specific,<br>Polymer Coated or<br>Chlorinated, Latex<br>Surgical Gloves,<br>Powder Free | Hand Specific, Polymer<br>Coated or Chlorinated,<br>Latex Surgical Gloves,<br>Powder Free with<br>Protein Claim (50<br>Microgram or less Per<br>Gram of Gloves) | Similar | | Color Information | - | - | Natural | Natural | Same | | Material | - | | Natural Rubber | Natural Rubber | Same | | Single Use | - | - | Yes | Yes | Same | | Sterility | ISO<br>11737-2 | - | Sterile | Sterile | Same | | Sterilization Method | - | - | Gamma Irradiation | Gamma Irradiation | Same | | Packaging | - | - | Packed in Pouches | Packed in Pouches | Same | | Table 2: Summary of the Non-Clinical Testing for the Subject Device and Comparison to the Predicate Device. | | | | | | | Characteristic | Standard | Specification | Subject Device<br>Sterile Latex<br>Surgical Powder<br>Free<br>K190241 | Legally Marketed<br>Predicate Device<br>K014230 | Remark | | Dimension | ASTM<br>D3577-<br>15 | | | | | | Length (size: 5.5), mm | | 245 min | Meet 245mm min | Meet 245mm min | Same | | Length (size: 6.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 6.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 7.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 7.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 8.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 8.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Length (size: 9.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | | | Thickness (cuff), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | Same | | Thickness (palm), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | | | Thickness (finger), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | | | Width (size: 5.5), mm | | $70 \pm 6$ | Meet $70 \pm 6$ mm | Meet $70 \pm 6$ mm | | | Width (size: 6.0), mm | | $76 \pm 6$ | Meet $76 \pm 6$ mm | Meet $76 \pm 6$ mm | | | Width (size: 6.5), mm | | $83 \pm 6$ | Meet $83 \pm 6$ mm | Meet $83 \pm 6$ mm | Same | | Width (size: 7.0), mm | | $89 \pm 6$ | Meet $89 \pm 6$ mm | Meet $89 \pm 6$ mm | | | Width (size: 7.5), mm | | $95 \pm 6$ | Meet $95 \pm 6$ mm | Meet $95 \pm 6$ mm | | | Width (size: 8.0), mm | | $102 \pm 6$ | Meet $102 \pm 6$ mm | Meet $102 \pm 6$ mm | | | Width (size: 8.5), mm | | $108 \pm 6$ | Meet $108 \pm 6$ mm | Meet $108 \pm 6$ mm | | | Width (size: 9.0), mm | | $114 \pm 6$ | Meet $114 \pm 6$ mm | Meet $114 \pm 6$ mm | | | Water Leak Test,<br>1000 ml | ASTM<br>D3577-<br>15 ASTM<br>D5151-<br>06 | | | | Same | | Before Aging, AQL | | G- I, AQL 1.5<br>(FDA GII, AQL<br>1.5) | Meet AQL 1.5 | Meet AQL 1.5 | | | After Aging, AQL | | | Meet AQL 1.5 | Meet AQL 1.5 | | | Physical Properties | ASTM<br>D3577-<br>15 | | | | | | (Before Ageing)<br>i) TensileStrength<br>(MPa) | | Min. 24 | Meet 24MPa min. | Meet 24MPa min. | Similar | | ii) Ultimate Elongation<br>(%) | | Min. 750 | Meet 750% min | Meet 750% min | | | ii) Stress at 500%<br>Elongation (MPa) | | Max. 5.5 | Meet 5.5 MPa max | Meet 5.5 MPa max | | | (After Aging)<br>i) Tensile Strength<br>(MPa) | | Min. 18 | Meets 18MPa min | Meets 18MPa min | | | ii) Ultimate Elongation<br>(%) | | Min. 560 | Meet 560% min. | Meet 560% min. | | | Characteristic | Standard | Specification | Subject Device<br>Sterile Latex<br>Surgical Powder<br>Free<br>K190241 | Legally Marketed<br>Predicate Device<br>K014230 | Remark | | Residual<br>Powder<br>Content | ASTM<br>D3577-15<br>ASTM<br>D6124-06 | Max.<br>2mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Similar | | Residual<br>Powder<br>Content, mg/glove | | | | | | | Extractable<br>Protein<br>Content | ASTM<br>D5712-10 | 50 µg/dm²<br>and below | Meet Specification | 50 µg/dm² and below | Similar | | Water Extractable<br>Protein Content,<br>µg/dm² | | | | | | | Biocompatibility Test | | | | | | | i) Primary Skin<br>Irritation Test | ISO 10993-<br>10 | No Animal<br>Irritation | Passes<br>i) Primary Skin<br>Irritation Test.<br>Conclusion: Under the<br>conditions of this<br>study the test material<br>did not cause an<br>irritant response | Passes<br>i)Primary Skin Irritation<br>Test.<br>Conclusion: Under the<br>conditions of this study<br>the test material did not<br>cause an<br>irritant<br>response. | Same | | ii) Skin Sensitization<br>Test | ISO 10993-<br>10 | No Animal<br>Sensitization | ii)Dermal<br>Sensitization<br>Test.<br>Conclusion: Under<br>the conditions of this<br>study, the test<br>material did not<br>produce a skin<br>sensitization effect | ii) Dermal Sensitization<br>Test.<br>Conclusion: Under the<br>conditions of this study,<br>the test material did not<br>produce a skin<br>sensitization effect | Same | | iii) Cytotoxicity Test | ISO 10995-<br>5 | Non-<br>cytotoxicity | moderate-cytotoxicity<br>at 6 cm²/mL<br>extraction | Data not available from<br>manufacture | Different | | iv) Acute Toxicity Oral | ISO 10993-<br>11 | No toxic | No adverse biological<br>reaction | Data not available from<br>manufacture | Different | | v) Pyrogenic Test | USP<br>General<br>Chapter<br>40, | Non<br>pyrogenic | Non pyrogenic | Data not available from<br>manufacture | Different | ### Summary of Non-Clinical Testing Testing performed as per ASTM D3577-15, Standard Specification for Rubber Surgical Gloves, and 21 CFR 878.4460. The subject device meets all the ASTM D3577-15 requirements. The table below summarizes the non-clinical tests performed and the standards used in this submission. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" which is in a light yellow color. In the middle of the word "GLOVE" is a blue circle with a light yellow hand in the center. Below the word "GLOVE" is the text "CAREPLUS-DESCARPACK". # CAREGLOVE GLOBAL SDN B Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" in smaller yellow letters. A hand is in the middle of the word "GLOVE". The words "CAREPLUS-DESCARPACK" are in small blue letters at the bottom. # CAREGLOVE GLOBAL SD Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com Non-clinical laboratory and animal-based tests indicate that the sterile latex surgical glove, powder free meets all the performance and biocompatibility requirements for the referenced standards. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the words "CARE GLOVE" stacked on top of each other. The word "CARE" is in blue, and the word "GLOVE" is in yellow, with a yellow hand in the middle of the word. Below the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in a smaller font size. # CAREGLOVE GLOBAL SD Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com ### Summary of Clinical Testing Not applicable. Conclusions: The conclusions drawn from nonclinical tests demonstrate that the subject device (K190241) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K014230.