Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )

{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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 18, 2014 Ever Light Plastic Products Company, Ltd. C/O Ms. Kathy Liu Project Manager Hongray USA Medical Products, Inc. 3973 Schaefer Avenue Chino, CA 91710 Re: K142570 Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 22, 2014 Received: October 28, 2014 Dear Ms. Liu: 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. {1}------------------------------------------------ Page 2 - Ms. Liu 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 (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142570 Device Name Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Indications for Use (Describe) A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) ### 510(K) SUMMARY This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR \$807.92. The assigned 510(K) number is: #### 1. Owner's Identification : Mr. Zhang Litao Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Tel: 86-311-83601854 Fax: 86-311-83616934 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: September 9, 2014 ### 2. Name of the Device: Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I ### 3. Predicate Device Information: Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K101135) ### 4. Device Description: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 {4}------------------------------------------------ Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application. ### 5. Intended Use of the Device: A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. ### 6. Technological Characteristics and Substantial Equivalence: Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) is substantially equivalent in safety and effectiveness to the Hongze Plastic Technology Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K 101135). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use. And the properties between the subject device and the predicate device are compared in the following table: | Characteristics | Standard | Device Performance | | Result of<br>comparison | |--------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | | | Predicate device | Subject Device | | | Product Code | / | LYZ | LYZ | Similar | | Intended Use | / | Predicate device is<br>disposable non-<br>sterile device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | Subject device is<br>disposable non-<br>sterile device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | Similar | | Labeling | / | There are no special<br>labeling claims and<br>do not claim gloves<br>as hypoallergenic on<br>labels. | There are no special<br>labeling claims and<br>do not claim gloves<br>as hypoallergenic on<br>labels. | Similar | | Device Materials | / | Vinyl | Vinyl | Similar | | Color | / | Yellow White Blue<br>Pink | Yellow White Blue<br>Pink | Similar | | Device tolerances and specifications & Performance Data: | | | | | | Characteristics | Standard | Device Performance | | Result of<br>comparison | | Tensile strength:<br>before and after<br>aging | ASTM<br>D 5250-06<br>(2011) | Before aging:<br>14.3-17.6MPa<br>After aging:<br>13.3-16.8Mpa | Before aging:<br>15.2-18.1Mpa<br>After aging:<br>14.6-17.4Mpa | Similar | | Ultimate<br>elongation:<br>before and after<br>aging | ASTM<br>D 5250-06<br>(2011) | Before aging:<br>380-429%<br>After aging:<br>370-401% | Before aging:<br>390-470%<br>After aging:<br>360-450% | Similar | | Freedom from<br>pinholes | ASTM<br>D 5250-06<br>(2011) | G-I, AQL2.5<br>125 glove sampled<br>and 1 piece leaks | G-I, AQL2.5<br>125 glove sampled<br>and 0 piece leaks | Similar | | Dimensions:<br>Overall<br>length,<br>Width, Palm<br>and<br>Finger<br>thickness | ASTM<br>D 5250-06<br>(2011) | Length:245-246mm<br>Width: S/86, M/96,<br>L/106, XL/116<br>Palm Thickness:<br>0.08-0.10mm<br>Finger Thickness:<br>0.10-0.11mm | Length:232-245mm<br>Width: S/87, M/97,<br>L/107, XL/118<br>Palm Thickness:<br>0.08-0.10mm<br>Finger Thickness:<br>0.10-0.12mm | Similar | | Residual powder | ASTM<br>D 5250-06<br>(2011) | 0.9mg/glove | 0.16 mg/glove | Similar | | Biocompatibility | | | | | | Primary<br>skin<br>irritation test | ISO<br>10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Similar | | Dermal<br>sensitization<br>assay | ISO<br>10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Similar | | Indications<br>For<br>Use | / | Predicate device is<br>disposable non-<br>sterile device<br>intended for<br>medical purpose<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination | Subject device is<br>disposable non-sterile<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and | Similar | | Characteristics | Standard | Device Performance | | Result of comparison | | | | Predicate device | Subject Device | | | | | between patient and examiner. | examiner. | | {5}------------------------------------------------ Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) {6}------------------------------------------------ Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device. # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows: | Testing Items | FDA-recognized<br>Standard<br>Requirements | Inspection<br>Level and AQL | Actual Testing<br>Results | Conclusion | |-----------------------------|---------------------------------------------|-----------------------------|-------------------------------------------------------------|------------| | Overall<br>Length<br>(mm) | 230 for all sizes<br>minimum | S-2, AQL4.0 | S: 232-245mm<br>M:233-241mm<br>L:236-243mm<br>XL: 234-242mm | Pass | | Width<br>(mm) | S: 85±5<br>M: 95±5<br>L: 105±5<br>XL: 115±5 | S-2, AQL4.0 | 87-88 mm<br>97-98 mm<br>107-108 mm<br>118-119 mm | Pass | | Palm<br>Thickness<br>(mm) | 0.08mm<br>minimum | S-2, AQL4.0 | 0.08mm | Pass | | Finger<br>Thickness<br>(mm) | 0.05mm<br>minimum | S-2, AQL4.0 | 0.10-0.12mm | Pass | | Tensile Strength (Mpa) | | | | | | Before aging | 11Mpa minimum | S-2, AQL4.0 | 15.2-18.1Mpa | Pass | | After aging | 11Mpa minimum | S-2, AQL4.0 | 14.6-17.4Mpa | Pass | | Ultimate Elongation (%) | | | | | | Before aging | 300% minimum | S-2, AQL4.0 | 390-470% | Pass | | After aging | 300% minimum | S-2, AQL4.0 | 360-450% | Pass | | Pinhole | 2.5 | G-I | 125 glove sampled<br>and 0 piece leaks,<br>meet AQL2.5 | Pass | {7}------------------------------------------------ Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000 Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) | | | | requirements | | |----------------------------------------|---------------------------------------------------|-----|---------------------------------------------------|------| | Residual<br>Powder | Not more than<br>2mg per glove | N=5 | 0.16mg | Pass | | (a) Primary<br>Skin Irritation<br>Test | Under conditions of the study, not<br>an irritant | | Under conditions of the study, not<br>an irritant | | | (b) Dermal<br>Sensitization<br>Study | Under conditions of the study, not<br>an irritant | | Under conditions of the study, not<br>an irritant | | # 8. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing. # 9. Labeling: We do not claim our gloves as hypoallergenic on our labels. # 10. Conclusions: Ever Light Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) conform fully to ASTM D 5250-06 (2011) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.