POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
Device Facts
| Record ID | K110972 |
|---|---|
| Device Name | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR |
| Applicant | Ppp Medical and Safety Products Company Limited |
| Product Code | LYZ · General Hospital |
| Decision Date | Jun 6, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Story
Disposable vinyl patient examination gloves; worn on examiner's hand or finger; intended to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare providers. Device is non-sterile and powder-free.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including physical properties, dimensions, freedom from pinholes (21 CFR 800.20), powder residual (ASTM D6124-06), and biocompatibility (ISO 10993-10).
Technological Characteristics
Vinyl material; powder-free; non-sterile. Meets ASTM D5250-06e1 for dimensions and physical properties. Biocompatibility testing per ISO 10993-10 (primary skin irritation and dermal sensitization).
Indications for Use
Indicated for use as a disposable, non-sterile patient examination glove worn by examiners to prevent cross-contamination between patient and examiner.
Regulatory Classification
Identification
A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. (K091663)
Submission Summary (Full Text)
{0}------------------------------------------------
## Section C 510(k) Summary (21 CFR 807.92)
K110972
JUN - 6 2011
# 510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________ " (applicant leave blank)
Premarket Notification [510(k)] Summary
### [(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | PPP Medical and Safety Products Company<br>Limited |
|--------------------------------|----------------------------------------------------|
| Submitter's address : | Xinlian,Houqiao Town, Wuxi,Jiangsu,214106,China |
| Phone number : | 0086-510-88725378 |
| Fax number : | 0086-510-88725378 |
| Name of contact person: | Mr. Zou Xiaojun |
| Date the summary was prepared: | Feb 9. 2011 |
#### [(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves,<br>Light Yellow Color |
|-------------------------|-------------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves,<br>Light Yellow Color<br>Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
#### [(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
{1}------------------------------------------------
Predicate device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.. K091663 .
#### [(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
#### [(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.
## [(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimension | ASTM standard D 5250-06 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 el<br>and D6124-06 | Meets<br><2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits<br>AAMI / ANSI / ISO 10993-10<br>Dermal sensitization in the guinea pig<br>AAMI / ANSI / ISO 10993-10 | Passes<br>Not a Primary Skin Irritation<br>Passes<br>Not a Dermal sensitization |
### [(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, meet requirements per ASTM D5250-06 e1. per ASTM D6124-06. per 21 CFR 800.20 and FDA recognition number 2-152: AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006.
### [(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
### [{b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AOL., meet labeling claims.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is as safe, as effective, and performs as well as the predicate device,
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.. K091663 .
. .
{2}------------------------------------------------
Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
PPP Medical and Safety Products Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606, Building 1, Jian Xiang Yuan No. 209, Bei Si Huan Zhong Road Hai Di, Beijing CHINA 100083
JUN - 6 2011
Re: K110972
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves. Light Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 20, 2011 Received: May 12, 2011
Dear Mr. Xiaoan:
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.
{3}------------------------------------------------
Page 2 - Mr. Xiaoan
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 régulations 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Anthony Di awater
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
#### INDICATIONS FOR USE
PPP Medical and Safety Products Company Limited Applicant:
510(k) Number (if known): *
Device Name: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elynchith R, Claverie-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110972
