POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED

{0}------------------------------------------------ ## AUG 1 5 2003 # 510(K) SUMMARY ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER FREE NITRILE EXAMINATIN GLOVES (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on April 3,2003 The assigned 510(K) number is K031157 #### 1.0 Submitter: Qingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road. Pingdu., Qingdao, China #### 2.0 Regulatory Affairs Contact: ZeChuan Shao Name: Phone No .: 408 980 1348 408 980 1356 Fax No .: #### 3.0 Name of device: Undetermined Trade Name: Examination Glove Common Name: Classification Name: Patient Examination Glove, Powder Free ## 4.0 Identification of The Legally Marketed Device: Class I nitrile patient examination gloves, 80LZA, non-sterile, powder free with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, that meets all the requirements of ASTM standard D 6319-00ae3 and FDA 21 CFR 800.20. ### 5.0 Device Description: Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20. ## 6.0 Intended Use of The Device: The powder free nitrile examination glove (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, is a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants. {1}------------------------------------------------ K031157 ## 7.0 Summary of the Technological Characteristics of the Device: The Powder Free Nitrile Examination Gloves (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards: | Characteristics | Standards | Device Performance | |--------------------------|------------------------------------------------------------|--------------------| | Dimensions | ASTM D 6319-00ae3 | Meets | | Physical Properties | ASTM D 6319-00ae3 | Meets | | Freedom from<br>Pinholes | ASTM D 6319-00ae3<br>FDA 21 CFR 800.20 | Meets | | Powder Residue | ASTM D 6124-01 | Meets, <2 mg/glove | | Biocompatibility | Primary Skin Irritation In Rabbits<br>Dermal Sensitization | Passes<br>Passes | ## 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The standards used by Bestex Rubber & Plastic Products Co., Ltd. to determine substantial equivalence are based on ASTM 6319-00ae3 AND FDA 21 CFR 800.20. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5 Primary Skin Irritation and Skin Sensitization testing were also conducted with results meets all performance and biocompatibility requirements. - 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data No new clinical test were conducted under this 510(K) ## 10.0 Other Information Deemed Necessary by FDA: Not applicable. ## Conclusion The data presented indicate that the Powder Free Nitrile Examination Glove with water soluble natural Vitamin E and Aloe Vera, Peppermint Scented (blue) meets ASTM standards, meet FDA pinhole requirements, biocompatibility requirements, and labeling claims. Consequently, this device is substantially equivalent to currently marketed devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. AUG 1 5 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Qingdao Bestex Rubber & Plastic Products Company Limited C/O Mr. Zechuan Shao Regulatory Affairs 2576 Lafayette Street Santa Clara, California 95050 Re: K031157 Trade/Device Name: Powder-Free Nitrile Examination Glove (Blue) With Natural Water Soluble Vitamin E and Alove Vera, Peppermint Scented Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 2, 2003 Received: August 4, 2003 Dear Mr. Shao: 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. Zechuan Shao 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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Patricia Cuencoffor Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K031157 ## Qingdao Bestex Rubber & Plastic Products Co., Ltd. Add: 14-2, Hangzhou Road, Pingdao, China Tel: 0086 532 833339 Fax: 0086 532 8312027 ## 3.0 Indications for Use Statement: ## INDICATIONS FOR USE Applicant: Qingdao Bestex Rubber & Plastic Products Co., Ltd. 510(k) Number(if known): Device Name: Powder-free nitrile examination glove (blue) with natural water soluble Vitamin E and Alove Vera, Peppermint scented #### Indications For Use: The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s)to prevent contamination between patient and examiner. > .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation(ODE) Prescription Use Per 21 CFR 801.109 OR Over-The-Counter (Optional Format 1-2-96) Qlin S. Lin Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K031157 3