UniTex Non-Sterile, Powder-Free, Latex Examination Glove

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a series of human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 11, 2017 UG Global Resources Sdn Bhd Kenneth Stanton President UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, California 92626 Re: K161961 Trade/Device Name: UniTex Non-Sterile, Powder-Free, Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 5, 2017 Received: April 7, 2017 Dear Kenneth Stanton: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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. # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161961 Device Name UniTex Non-Sterile, Powder-Free, Latex Examination Glove Indications for Use (Describe) A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Publishing Services (301) 443-6740 EF PAGE 8. 56 {3}------------------------------------------------ #### SUMMARY PREMARKET 510(k) NOTIFICATION UniTex Non-Sterile, Powder-Free, Latex Examination Glove K161961 #### Submission Applicant- UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Data Abd Rahman 70000, Seremban, Negeri Sembilan, Malaysia #### Official Correspondent - Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271 Date of Preparation: April 13, 2017 #### Trade Name: UniTex Non Sterile, Powder Free, Latex Examination Glove Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Latex examination glove, LYY that meets all of the requirements of ASTM D3578-05(2015). Predicate Device: K010879.UniGlove Powder-Free Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Device Description: The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color. 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 the patient and the examiner. {4}------------------------------------------------ Substantial Equivalence Table- | | Color | Material | Biocompatibility Tests | ASTM D3578<br>Tensile Strength (MPa) | ASTM D3578<br>Elongation % | |--------------------------------|---------|----------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------| | Subject<br>Device<br>K161961 | Natural | Latex | ISO 10993-10 - Primary Irritation Test- Under the<br>conditions of the study, the device is non-irritating | Before Aging- min 18.0 | Before Aging - min.<br>650 | | | | | ISO 10993-10 - Dermal Sensitization Assay -<br>Under the conditions of the study, the device is a<br>non-sensitizer | After Aging - min 14.0 | After Aging - min.<br>500 | | Predicate<br>Device<br>K010879 | Natural | Latex | ISO 10993-10 - Dermal Sensitization Assay - Under<br>the conditions of the study, the device is a non-<br>sensitizer | Before Aging- min 21.0 | Before Aging- min.<br>700 | | | | | ISO 10993-10 - Primary Irritation Test- Under the<br>conditions of the study, the device is non-irritating | After Aging- min 16.0 | After Aging - min.<br>500 | | | ASTM D3578<br>Dimensions | ASTM D5151<br>Waterleak | ASTM D5712<br>Protein Claim | ASTM D6124<br>Powder Content | | Sizes | Single Use | Indications for Use | |--------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------|------------------------------------|--------------------------------|-------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject<br>Device<br>K161961 | Palm Width - 95mm+/-10 Medium size<br>Length: 240mm min<br>Thickness; Min .08mmPalm and finger | AQL 1.5 | 50 Micrograms or less of total<br>water Soluble Protein per dm2 | Max 2.0mg/glove<br>Avg .06mg/glove | Subject<br>Device<br>K161961 | XS-XL | Yes | A patient examination glove is a disposable device intended for medical purposes that is worn on the<br>examiner's hand or finger<br>to prevent contamination between patient and examiner | | Predicate<br>Device<br>K010879 | Palm Width- 95mm +/- 10 Medium size<br>Length: 240 mm min<br>Thickness: Min .15mm Palm and Min .17mm finger | AQL 1.5 | 50 Micrograms or less | Max 2.0mg/glove<br>Avg .40mg/glove | Predicate<br>Device<br>K010879 | XS-XL | Yes | A patient examination glove is a disposable device intended for medical purposes that is worn on the<br>examiner's hand or finger to prevent contamination between patient and examiner | {5}------------------------------------------------ Comparisons- Both Kl61961 and K110879 are Chlorination Gloves. Both gloves have protein levels below the 50 Microgram per dm Threshold, both have the same specifications, both have the same AQL 1.5 for pinholes and similar powder content. Both glocomatibility tests. Additionally, both devices have similar tensile strength and elongation performance. {6}------------------------------------------------ | Material: | Latex | Cuff: | Beaded | Summary of Technological Characteristics: | | | | |--------------------|------------------------------------------------------------------------------------------|-------|--------|-------------------------------------------|-------------------|--|--| | Protein: | 50 Micrograms or less of total water soluble protein per dm2 | | | Powder Residue: | Maximum 2mg/glove | | | | Quality Assurance: | In compliance with ASTM D3578-05, ISO 2859-1:1999, manufactured under ISO 9001:2008, ISO | | | | | | | | 13485:2003 | and | EN | ISO | 13485:2012 | | | | # Inspection Parameters: | Criteria | Inspection Level | AQL | |-------------------------|------------------|-----| | Dimensions | S-2 | 4.0 | | Physical Properties | S-2 | 4.0 | | Water Tight Test 1000ml | G-1 | 1.5 | | Visual Major Defects | G-1 | 1.5 | | Visual Minor Defects | G-1 | 2.5 | {7}------------------------------------------------ Physical Properties: Dimensions: Overall Length: 240 mm minimum Width: Thickness: 95 mm minimum (for medium glove) 0.08 mm minimum BEFORE AGING Tensile Strength: 18.0 Mpa minimum Ultimate Elongation: 650% minimum ## AFTER AGING 14.0 Mpa minimum 500% minimum ### Special Properties: None Packaging: 100 gloves per dispenser box, 10 boxes per case, 1,000 gloves per case Sizes: XS-XL Conclusion: The UniTex Non-Sterile, Powder-Free, Latex Examination Glove meets the physical property requirements of ASTM D3578-05(2015), the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at 50 Micrograms or less of total water soluble protein per dm² controlled during routine production as per ASTM 5712-15. This product is as safe, as effective, and performs as well or better than the legally marketed device cleared under 510(k) # K010879.