POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR

K110247 · Jiangsu Dongling Plastic & Rubber Co., Ltd. · LZA · Jun 10, 2011 · General Hospital

Device Facts

• Record ID: K110247
• Device Name: POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
• Applicant: Jiangsu Dongling Plastic & Rubber Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Patient Examination Gloves,Blue 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 nitrile synthetic rubber gloves; worn on examiner's hand or finger. Used in clinical settings to provide a protective barrier; prevents contamination between patient and examiner. Device is non-sterile. Performance verified against ASTM D 6319 standards for dimensions, physical properties, and powder residuals. Biocompatibility confirmed via ISO 10993-10 testing for skin irritation and sensitization.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing (ASTM D 6319), freedom from pinholes (21 CFR 800.20), powder residual analysis (ASTM D6124-06), and biocompatibility testing (ISO 10993-10 for primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Nitrile synthetic rubber. Form factor: Disposable, non-sterile glove. Standards: ASTM D 6319 00a(2005)e1, ASTM D6124-06, ISO 10993-10. Powder residual: <2mg/glove. Biocompatibility: Passes primary skin irritation and dermal sensitization tests.

Indications for Use

Indicated for use as a non-sterile, disposable protective barrier worn on the hands of healthcare 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 BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. (K082598)

Submission Summary (Full Text)

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### Section C (rev.02)510(k) Summary (21 CFR 807.92)

### 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: K 110247

Premarket Notification [510(k)] Summary

Submitter's name :

JiangSu DongLing Plastic & Rubber Co.,Ltd

DongWu Road, Economic Development Zone,

SuQian,JiangSu Province, 223800,China

Submitter's address :

Name of contact person:

Proprietary/Trade name:

Phone number :

Fax number :

Mr.ZhiJun Xu

0086-527-82860080

0086-527-82860080

Dec.24, 2010 Date the summary was prepared:

Device Name:

Powder Free Nitrile Patient Examination Gloves,Blue Color

Powder Free Nitrile Patient Examination Gloves, Blue Color clients private labeling Other

Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Exam gloves Patient examination glove 21 CFR 880.6250 General Hospital (80) LZA

Class 1* Powder Free Nitrile Patient Examination Gloves,Blue Color that meets all of the requirements of ASTM D 6319 00a(2005)e1.

Predicate device: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. K082598.

Device Description: Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

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Device Intended Use (indication for use): Powder Free Nitrile Patient Examination Device Intended 'Use (Indication' for use). Towardical purposes that is worn on the Gloves,Blue Color is a disposable device intended for then patient and examiner.

# A summary of the technological characteristics of new device compared to the predicate device.

The Powder Free Nitrile Patient Examination Gloves,Blue Color, non sterile are summarized The Powder Free Nitrile Patient Exammation Croves,Bhile Colors, Mor equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimension | ASTM standard D 6319 00a (2005)el. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)el. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)el.<br>and D6124-06 | Meets<br><2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits<br>ISO 10993-10<br>Dermal sensitization in the guinea pig<br>ISO 10993-10 | Passes<br>Not a Primary Skin Irritation<br>Passes<br>Not a Dermal sensitization |

## A brief discussion of the nonclinical submitted, reference, or relied on in the premarket A brief discussion of the or a determination of substantial equivalence _

Powder Free Nitrile Patient Examination Gloves,Blue Color, meet requirements per ASTM
Portal Property on Organise One SER 10002 10: 2007/4md 11 Powder Free Nitrile Patient Exammation Oloves,Diae Color, Most Squares 2006.

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

# A brief discussion of the clinical submitted, reference, or relied on in the premarket A brief discussion of the Chilection of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### Conclusions

....

Conclusions
It can be concluded that the Powder Free Nitrile Patient Examination Gloves and pinhology A Ol It can be concluded that the Powder Free Nithic Fatent Bhanniation and FDA is and the AQL..
ASTM standard or equivalent standard and FDA requirements for waterleak test on pi meet labeling claims.

It can be concluded that the Powder Free Nitrile Patient Examination Gloves,Blue Color is as safe, as effective, and performs as well as the predicate device, POWDER FREE BLUE safe, as effective, and performs as well as the predicate as now be and of the county of the GROUP CO., LTD., K082598

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Jiangsu Dongling Plastic Rubber Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Co. Ltd. Room 1606 Bldg 1 Yuan #209 Bei Si Huan Zhong Road Beijing, PR China 100083

JUN 1 0 2011

Re: K110247

Trade/Device Name: Powder Free Nitrile Patient Examination Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 26, 2011 Received: May 26, 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.

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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 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 (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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthem Vam

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

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#### INDICATIONS FOR USE

JiangSu DongLing Plastic & Rubber Co.,Ltd Applicant:

KI10247 510(k) Number (if known): *

Powder Free Nitrile Patient Examination Gloves,Blue Color Device Name:

#### Indications For Use:

Powder Free Nitrile Patient Examination Gloves,Blue 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)

Elizabeth F. Claverie-Williams

Jivision Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices

510(k) Number: K110247