LATEX EXAMINATION GLOVES (POWDER FREE)

{0}------------------------------------------------ MAY 1 4 2012 K120692 ## FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information ## Date: 11 April 2012 ### 1.0 Submitter: Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, Malaysia +603 3291 0516 Telephone No .: +603 3291 0542 Fax No.: ### 2.0 Contact Person: | Contact: | Ms Tracy Ngui | |-----------------|----------------| | Telephone No .: | +603 3291 0516 | | Fax No .: | +603 3291 0542 | #### 3.0 Name of Device: Trade Name: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove #### 4.0 Identification of the Legally Marketed Device: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water. Extractable Protein). Class I patient examination gloves, Latex - 80LYY, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove. Predicate Device: K062917, Non-Sterile Powder Free Latex Patient Examination Glove, With Extractable Protein Content Labeling Claim (50 Micrograms per gram of glove or Less). {1}------------------------------------------------ ### 5.0 Description of Device: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). ### 6.0 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 to prevent contamination between patient and examiner. ### 7.0 Summary of the Technological Characteristics of the Device: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm4 of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards): | Characteristic | Standards | Device Performance | |------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Dimensions | ASTM D 3578-05<br>(2010) | Meets | | Physical Properties | ASTM D 3578-05<br>(2010) | Meets | | Freedom from pin-holes | ASTM D 5151-99<br>(2006)<br>ASTM D 3578-05<br>(2010) | Meets | | Powder Free Residue | ASTM D 6124-06<br>ASTM D 3578-05<br>(2010) | Meets | | Protein Content | ASTM D 5712-10<br>ASTM D 3578-05<br>(2010) | Meets | | Biocompatibility | Dermal Sensitization<br>(as ISO 10993-10:2010)<br><br>Primary Skin<br>Irritation Test<br>(as ISO 10993-10:2010) | Not a contact skin sensitizer<br><br>Not a primary skin irritant | {2}------------------------------------------------ ## 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The performance test data that support a determination of substantial equivalence are described above. - Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 Clinical data is not needed for market cleared examination gloves. #### 10.0 Conclusion It can be concluded that the Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dmof glove or Less of Water Extractable Protein), is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. The device comparison below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination. | Characteristics | Predicate Device | Proposed Device | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K062917, Non-Sterile Powder<br>Free Latex Patient Examination<br>Glove, with Extractable Protein<br>Content Labeling Claim (50<br>Micrograms per gram of glove<br>or less) | Powder Free Latex Patient<br>Examination Glove, with Protein<br>Content Labeling Claim,<br>Chlorinated (Contains 50<br>Micrograms per dm² of glove or<br>less of Water Extractable Protein) | | Device Description/<br>Regulation Number | Patient Examination Glove/<br>21 CFR Part 880.6250 | Identical | | Product Code | 80 LYY | Identical | | Intended Use | Intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner. | Identical | | Indications for Use | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | Identical | | Characteristics | Predicate Device | Proposed Device | | | K062917, Non-Sterile Powder<br>Free Latex Patient Examination<br>Glove, with Extractable Protein<br>Content Labeling Claim (50<br>Micrograms per gram of glove<br>or less) | Powder Free Latex Patient<br>Examination Glove, with Protein<br>Content Labeling Claim,<br>Chlorinated (Contains 50<br>Micrograms per dm² of glove or<br>less of Water Extractable Protein) | | Design | Ambidextrous, in different sizes<br>per ASTM D3578 dimension<br>requirement. | Identical | | Materials | Natural Rubber Latex | Identical | | Color | Natural Color | Identical | | Performance<br>I. Sterility | Not Applicable (Non-Sterile) | Identical | | II. Freedom from<br>holes | Meets ASTM D3578 | Identical | | III. Dimension | Meets ASTM D3578 | Identical | | IV. Physical<br>Properties | Meets ASTM D3578 | Identical | | V. Powder Free<br>Residue | Meets ASTM D3578 | Identical | | VI. Protein<br>Content | Meets ASTM D3578 | Identical | | Single Use | Yes | Identical | | Biocompatibility<br>Test | Passes<br>i. Primary Skin Irritation Test<br>ii. Dermal Sensitization Test | Identical | | Packaging | Packed in Dispenser Boxes | Identical | | Labeling Claim | With Extractable Protein<br>Content Labeling Claim | Identical | ## Substantial Equivalence Comparison Table {3}------------------------------------------------ . . ' : . {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly suggesting care or support. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Tracy Ngui Ouality Assurance Manager Top Calibre Sdn. Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, MALAYSIA MAY 1 4 2012 Re: K120692 Trade/Device Name: Powder Free Latex Examination Glove with Protein Content Labeling Claim, Chlorinated, (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 11, 2012 Received: April 12, 2012 Dear Ms. Ngui: 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. 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. {5}------------------------------------------------ ## Page 2 - Ms. Ngui 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, cam Anthur Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Healthealth ## Enclosure {6}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated, Device Name: (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) ## Indications for Use: A 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation (ODE) Elizabeth F. Clavint-Willens Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page I of × 510(k) Number: K120692