POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE

{0}------------------------------------------------ # 1 V | Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X) ## FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information #### 1.0 Submitter: WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia. APR - 3 2009 Telephone No.: +603 3392 3088 Fax No.: +603 3392 2118 #### 2.0 Contact Person: | Contact: | Mr. SH TAN | |----------------|---------------------| | E-mail: | shtan@kossan.com.my | | Telephone No.: | +603 3291 2657 | | Fax No.: | +603 3291 0584 | #### 3.0 Name of Device: | Trade Name: | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with<br>Protein Labeling claim of 50 micrograms per dm2 of glove or less of<br>water soluble protein. | | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common Name: | Patient Examination Glove | | | Classification Name: | Patient Examination Glove. | | #### 4.0 Identification of The Legally Marketed Device: The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein, Class I Patient Examination gloves, 80LYY, meets all of the requirements of ASTM D3578 Standard Specification for Rubber Examination Gloves. #### 5.0 Description of Device: The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein will meet all the current specification for ASTM D3578. Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599 {1}------------------------------------------------ # Wear Safe (Malaysia) Sdn.Blid. (Company No.204396-X) #### 6.0 Intended Use of the Device: The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. #### 7.0 Summary of The Technological Characteristics of The Device: The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein possesses the following technological characteristic (as compared to ASTM or equivalent standards): | Characteristic | Standards | Device Performance | |----------------------------|-------------------------------------------------------|-------------------------------| | Dimensions | ASTM D3578 - 05 | Meets | | Physical Properties | ASTM D 412 - 06ae1 | Meets | | Freedom from pin-<br>holes | ASTM D 5151 - 06 | Meets | | Powder Free Residue | ASTM D 6124 - 06 | Meets | | Biocompatibility | Dermal Sensitization<br>(as per ISO 10993-10) | Not a contact skin sensitizer | | | Primary Skin Irritation Test<br>(as per ISO 10993-10) | Not a primary skin irritant | #### 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. #### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data are not needed for market cleared examination gloves. #### 10.0 Conclusion It can be concluded that the Powder Free Polymer Coated Latex Examination Gloves. Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this device is substantially equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA. Lọt 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR - 3 2009 Mr. S.H. Tan Regulatory Affairs Department Manager Wear Safe (Malaysia) SDN BHD Lot PT 13726, Jalan Haji Salleh, Batu 51/4 Off Jalan Meru, 41050 Klang Selangor Darul Ehsan MALAYSIA Re: K090327 Trade/Device Name: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein. Regulation Number: 21 CFR 878.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 6, 2009 Received: February 9, 2009 Dear Mr. Tan: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ ### Page 2 - Mr. Tan 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Anthony, J. austin ben Ginette Y Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X) ## INDICATIONS FOR USE Applicant: ### WEAR SAFE (MALAYSIA) SDN. BHD. 510(k) Number (if known): |くの9つ327 Device Name: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein. Indication For Use: A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shelly Murphy (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K900327 Page 1 of 1 Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599