Powder Free Vinyl Patient Examination Gloves (Green)

{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 or a representation of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 21, 2015 Supermax Plastic Products Co., Ltd % Ms. Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Ave. Chino, California 91710 Re: K152692 Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 24, 2015 Received: November 27, 2015 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}------------------------------------------------ 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 and Part 809); medical device 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. 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 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152692 Device Name Powder Free Vinyl Patient Examination Gloves (Green) Indications for Use (Describe) The Powder Free Vinyl Patient Examination Gloves (Green) 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 Druq 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}------------------------------------------------ # Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000 ## 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: K152692 #### 1. Owner's Identification : Mr. Wu Zhigang Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, 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: December 15, 2015 ## 2. Name of the Device: Trade Name: Powder Free Vinyl Patient Examination Gloves (Green) Common Name: Patient Examination Gloves Classification Name: Patient Examination Glove Classification Regulation: 21 CFR 880.6250 Classification Panel: 80 General Hospitals Product Code: LYZ Device Class: Class I ## 3. Predicate Device Information: Tangshan Hongyun Plastic Products Company Limited Powder-Free Yellow Vinyl Patient Examination Gloves (K141878) #### 4. Device Description: Powder Free Vinyl Patient Examination Gloves (Green) 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 (Reapproved 2011)--Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application. #### 5. Intended Use of the Device: {4}------------------------------------------------ # Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000 The Powder Free Vinyl Patient Examination Gloves (Green) 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: Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Green) is substantially equivalent in safety and effectiveness to the Tangshan Hongyun Plastic Products Company Limited's Powder-Free Yellow Vinyl Patient Examination Gloves (K141878). 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 | |-------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | Predicate device | Subject Device | comparison | | 510K number | | K141878 | K152692 | -- | | Product name | 1 | Powder-Free Yellow Vinyl<br>Patient Examination<br>Gloves | Powder Free Vinyl<br>Patient Examination<br>Gloves (Green) | Similar | | Product Code | | LYZ | LYZ | Same | | Intended Use | | Powder-Free Yellow Vinyl<br>Patient Examination<br>Gloves is a non sterile<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | The Powder Free Vinyl<br>Patient Examination<br>Gloves (Green) is<br>disposable non-sterile<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Same | | Size | | S/M/L/XL | S/M/L/XL | Same | | Compare all<br>materials used<br>to fabricate the<br>devices | | PVC | PVC | Same | | Dusting or<br>Donning<br>powder | | PU | PU | Same | | Compare<br>performance<br>data supporting<br>substantial<br>equivalence | | Meets<br>ASTM D5151-06(2011)<br>ASTM D 5250-06 (2011)<br>ASTM D6124-06(2011) | Meets<br>ASTM D5151-06(2011)<br>ASTM D 5250-06 (2011)<br>ASTM D6124-06(2011) | Same | | Color | | Yellow | Green | Similar | | | Standard | Device Performance | | Result of | | Characteristics | | Predicate device | Subject Device | comparison | | Single patient<br>use | / | Single patient use | Single patient use | Similar | | Dimensions:<br>Length | ASTM D 5250-<br>06 (2011) | Meets<br>230 mm min for all sizes | Meets<br>230 mm min for all sizes | Similar | | Dimensions:<br>Width | ASTM D 5250-<br>06 (2011) | Meets<br>S: 83-86 mm<br>M: 94-97 mm<br>L: 104-107 mm<br>XL: 113-115 mm | Meets<br>S: 85±5 mm<br>M: 95±5 mm<br>L: 105±5 mm<br>XL: 115±5 mm | Similar | | Dimensions:<br>Thickness | ASTM D 5250-<br>06 (2011) | Meets<br>Palm: 0.08 mm min<br>Finger: 0.05 mm min | Meets<br>Palm: 0.08 mm min<br>Finger: 0.05 mm min | Similar | | Tensile<br>strength:<br>before<br>and<br>after aging | ASTM D 5250-<br>06 (2011) | Meets<br>Tensile Strength≥11MPa | Meets<br>Tensile Strength≥11MPa | Similar | | Elongation<br>before and after<br>aging | ASTM D 5250-<br>06 (2011) | Meets<br>Elongation≥300% | Meets<br>Elongation≥300% | Similar | | Freedom from<br>pinholes | ASTM D 5250-<br>06 (2011)<br>ASTM D5151-<br>06<br>(Reapproved<br>2011) | Meets<br>G-I, AQL2.5 | Meets<br>G-I, AQL2.5 | Similar | | Residual<br>powder | ASTM D 5250-<br>06 (2011)<br>ASTM D6124-<br>06(Reaffirmati<br>on 2011) | Meets<br>Results below 2mg of<br>residual powder | Meets<br>Not more than 2mg per<br>glove | Similar | | Biocompatibility | Skin irritation<br>ISO 10993-10 | Under conditions of<br>the<br>study, not an irritant | Under conditions of the<br>study, not an irritant | Same | | | Sensitization<br>ISO 10993-10 | Under the conditions of the<br>study, not a sensitizer | Under the conditions of<br>the study, not a sensitizer | Same | | Labeling | / | Powder Free<br>Devices color: Yellow<br>Patient examination Glove<br>Non Sterile<br>Single use only<br>Manufactured for:<br>Lot | Powder Free<br>Devices color: Green<br>Patient examination<br>Glove<br>Non Sterile Single<br>use only<br>Manufactured for:<br>Lot | Similar | {5}------------------------------------------------ Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000 {6}------------------------------------------------ # Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000 Powder Free Vinyl Patient Examination Gloves (Green) 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: Powder Free Vinyl Patient Examination Gloves (Green) meet requirements per ASTM D 5250-06(2011), per ASTM D6124-06 (2011), ASTM D5151-06(2011), 21CFR 800.20 and ISO 10993-10 third edition 2010-08-01 #### 8. Discussion of Clinical Tests Performed: Clinical data was not included in the submission. Substantial equivalence of the subject device was supported by non-clinical testing. ## 9. Conclusions: Powder Free Vinyl Patient Examination Gloves (Green) 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. Drawn from the complete list of non-clinical tests, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. The subject device is substantially equivalent to the predicate device.