ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its head and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Maryalice Smith Regulatory Affairs Manager JUL 28 1997 Allegiance Healthcare Corporation 1500 Waukeqan Road #K McGraw Park, Illinois 60085 K972291 Re : Trade Name: Alleqiance Non Sterile Powder Free Latex Examination Glove With Protein Labeling Claim Requlatory Class: I Product Code: LYY Dated: May 28, 1997 Received: June 19, 1997 Dear Ms. Smith: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 \ {1}------------------------------------------------ Page 2 - Ms. Smith through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one regarders fication" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Patriccia Guerite/for Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ NO.306 6.9/18 JUL.14.1997" 9:55AM Image /page/2/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is in black and the background is white. Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, Illinols 60085-6787 847.473.1600 FAX: 847.785.2460 Page 1 of 1 | Applicant: | Allegiance Healthcare Corporation | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K972291 | | Device Name: | Non Sterile Powder-Free Latex Examination Gloves with a Protein Label Claim | | Indications For Use: | A 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. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE | (Division Sign-Off | | |---------------------------------------------------------------------|--------------------------------------------------------| | Division of Dental, Infection Control, and General Hospital Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) | | 510(k) Number | 4972291 | | Prescription Use<br>(Per 21 CFR 801.109) | cr | | | Over-The Counter Uss <div></div> | {3}------------------------------------------------ ### JUL 28 1997 #### K972291 XIII.510(k) SUMMARY Allegiance Healthcare Corporation Applicant: 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085 Contact Person: Maryalice Smith, (847) 785-3322 2. Manufacturing and Allegiance Healthcare Sdn. Bhd. Chlorination Facility: Plot 87 Kampung Jawa Bayan Lepas, Penang, West Malaysia 11900 Digitcare Corporation Sdn. Bhd. 3. Chlorination Facility: Lot 3 Jalan 1/113A, Batu 4 1/2, Jalan Kelang Lama, Kilang Yee Seng, 58000 Kuala Lumpur, Malaysia Maxi Support Sdn. Bhd. 99-L Lorong Perak 4, Kawasan Perusahaan Mergong. 05150 Alor Setar, Kedah Darul Aman, Malaysia. - 5. The Powder-Free Non-Sterile Latex Examination Gloves, with a protein label claim, are substantially equivalent to the Flexam Powdered Non-Sterile Examination Glove in regard to the material, design, physical characteristics and intended use. A battery of performance tests were conducted, verifying the acceptability of this product for its intended use. The Powder-Free Non-Sterile Latex Examination Gloves with a protein label claim were subjected to biological evaluation. The gloves passed the acceptability criteria for primary skin irritation, intracutaneous reactivity and skin sensitization as outlined in ISO 10993 1/USP XXIII. In addition, the product was found acceptable based on chemical analysis of materials. Test methods for inspection of gloves and for chemical, biocompatibility and physical testing are listed in Appendix C of this document. The leak test method employed is the FDA 1000 mL test method which is described in 21 CFR §800.20. This product meets the requirement specified in ASTM Standard Specification for Rubber Examiniation Gloves D3578-95. {4}------------------------------------------------ ## XIII. 510(k) SUMMARY (Con't) #### 7. 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Dimensions of the medium glove is as follows: | Size: Medium | | | |----------------|-------------------|----------------| | Length (cm) | min. 23.0 | min. 23.0 | | Width (cm) | 9.8-10.0 | 8.5-10.5 | | Thickness (cm) | | | | Cuff | 0.13 mm<br>(min.) | NA | | Palm | 0.19 mm<br>(min.) | 0.08 mm (min.) | | Finger | 0.20 mm<br>(min.) | 0.08 mm (min.) | - 9. Powder manufactured by Roquette America, Inc., Keokuk, Iowa 52632, (NDA 85-356) is used during manufacture. Powders which may be present due to the manufacturing process are removed through chlorination. The Quality Assurance method is included in Appendix E. No special claims are made for this product and the product is not expiration dated. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word "Allegiance" is written in all caps and is slightly slanted to the right. # XIV. STATEMENT OF SAFETY AND EFFECTIVENESS #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVESWITH A PROTEIN LABEL CLAIM | Manufacturer: | Allegiance Healthcare Sdn. Bhd.<br>Plot 87 Kampung Jawa<br>Bayan Lepas<br>Penang, West Malaysia 11900 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Maryalice Smith<br>1500 Waukegan Road, Bldg. K<br>McGaw Park, IL 60085 | | Telephone: | (847) 785-3322 | | Date Summary Prepared: | May, 1997 | | Product Trade Name: | Powder-Free Non-Sterile Latex Examination Gloves with a<br>Protein Label Claim | | Common Name: | Patient Examination Glove | | Classification: | Glove, Examination (Latex) | | Predicate Devices: | Flexam Examination Gloves (latex). | | Description: | The Powder Free Non Sterile Examination gloves with a<br>protein label claim are formulated using in-house<br>compounded latex and offered non-sterile. | | Intended Use: | Powder-Free Non-Sterile Latex Examination gloves with a<br>protein label claim. Gloves are a disposable device<br>intended for medical purposes that are worn on the<br>examiner's hand or finger to prevent contamination<br>between patient and examiner. | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic of a cluster of small squares arranged in a pattern that resembles a starburst or a stylized flower. The word "Allegiance" is written in a slightly italicized font, giving it a sense of movement or dynamism. ## XIV. STATEMENT OF SAFETY AND EFFECTIVENESS #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES WITH A PROTEIN LABEL CLAIM | Substantial Equivalence | Powder Free Non-Sterile Examination Gloves with a<br>protein label claim are substantially equivalent to the<br>Flexam Non-Sterile Examination Gloves in that they<br>provide the following characteristics:<br>- intended use<br>- size, configuration, packaging<br>- made of natural rubber latex<br>- tensile strength and thickness profiles | | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Summary of Testing: | Test | Result | | | Intracutaneous Reactivity | Glove does not elicit<br>irritation following<br>intradermal injection of<br>extracts. | | | Kligman Maximization | Glove does not display<br>sensitization potential to<br>produce skin sensitization | | | Ultimate Elongation<br>& Tensile Strength | Glove meets or exceeds<br>requirements for rubber | 21 --- Barrier Defects examination gloves per ASTM D3578-95. Glove meets or exceeds requirements per 21 CFR ASTM D3578-95, AQL=4.0. §800.20 and {7}------------------------------------------------ Image /page/7/Picture/2 description: The image contains the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic that resembles a plus sign made up of small squares. The word is slightly slanted upwards from left to right, giving it a dynamic appearance. The overall design is simple yet impactful, with the focus on the brand name. # XIV. STATEMENT OF SAFETY AND EFFECTIVENESS #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES WOTH A PROTEIN LABEL CLAIM Summary of Testing: Test Data/Test Method Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch. Result Gloves meet requirements for a low protein claim designation of 50 microgram or less of total water extractable protein per gram per glove using the ASTM Lowry test method (ASTM 5712-95).