POWDER FREE NITRILE EXAMINATION GLOVES

K110418 · W.A. Rubbermate Co., Ltd. · LZA · Jul 13, 2011 · General Hospital

Device Facts

• Record ID: K110418
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES
• Applicant: W.A. Rubbermate Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Examination Gloves are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.

Device Story

Powder-free nitrile examination gloves; made from butadiene acrylonitrile copolymer; worn by healthcare personnel; provides barrier protection against infectious materials and contaminants; prevents cross-contamination between personnel and patients; single-use disposable device.

Clinical Evidence

No clinical tests were conducted. Evidence consists of bench testing per ASTM D 6319-10 and 21 CFR 800.20, including primary skin irritation and delayed dermal contact sensitization studies in animal models (rabbits and guinea pigs), demonstrating no irritation or sensitization.

Technological Characteristics

Material: Nitrile compound (butadiene acrylonitrile copolymer). Form: Powder-free examination glove. Standards: ASTM D 6319-10. Biocompatibility: Tested for skin irritation and sensitization.

Indications for Use

Indicated for use as a disposable medical glove worn on the hand by healthcare and similar personnel to provide a barrier against potentially infectious materials and other contaminants.

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

• Class 1 Patient Examination glove (Product Code 80LZA)

Submission Summary (Full Text)

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# KI 10418

# Powder Free Nitrile Examination Gloves

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Attachment 13

# 510(k) SUMMARY

JUL 13 2011

#### POWDER FREE NITRILE EXAMINATION GLOVES

| Submitter's Name | W.A RUBBERMATE CO., LTD |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | 67/1 Bypass Road, Moo 4,<br>Nongmaidaeng, A. Maung,<br>Chonburi 20000, Tailand |
| Submitter's Phone Number | [phone] |
| Submitter's Fax Number | [phone] |
| Name of Contact Person | Terence Lim Sin Kooi |
| Date of Preparation | 08 February 2011 |
| Name of Device | |
| Trade Name | : POWDER FREE NITRILE EXAMINATION<br>GLOVES |
| Common Name | : Nitrile Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is<br>Being Claimed | Powder Free Nitrile Examination Gloves as<br>described in this 510 K Notification is<br>substantially equivalent to the current Class 1<br>Patient Examination glove bearing the product<br>code 80LZA ( 21 CFR 880.6250 ). It meets all the<br>current specifications listed under the ASTM<br>Specification D 6319 - 10 Standard Specification<br>for Nitrile Examination Gloves for Medical<br>Application. |
| Description of the Device | Powder Free Nitrile Examination Gloves is<br>substantially equivalent to the Class 1 patient<br>examination glove bearing the product code |
| | 80LZA ( 21 CFR 880.6250 ). It meets all the<br>current specifications listed under the ASTM<br>Specification D 6319 - 10 Standard Specification<br>for Nitrile Examination Gloves for Medical<br>Application¹. They are made from nitrile<br>compound(dispersion of butadiene acrylonitrile<br>copolymer. They are powder free gloves. |
| Intended Use of the Device | Powder Free Nitrile Examination Gloves are<br>intended for single use for medical purposes that<br>is worn on the hand of health care and similar<br>personnel to prevent contamination between the<br>health care personnel and the patients. |
| Summary of Technological Characteristic<br>Compared to the Predicate Device | There is no different technological characteristic.<br>Gloves are made from nitrile compound<br>(dispersion of butadiene acrylonitrile copolymer)<br>and the initial products are powder free nitrile<br>examination gloves. |
| Brief Description of Non-Clinical Tests | Testing performed per ASTM D 6319 - 10<br>Standard Specification for Nitrile Examination<br>Gloves for Medical Application and 21 CFR<br>800.20. Gloves meet all the current ASTM D<br>6319-10.<br>Primary skin irritation testing in the rabbit and<br>delayed dermal contact sensitization study in the<br>guinea pigs indicate no irritation or sensitization. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn from the Non-Clinical and<br>Clinical Tests | Non-Clinical laboratory and animal based test<br>data indicate that the powder free product meets<br>all performance and biocompatibility<br>requirements. |
| Other Information Deemed Necessary by FDA | Not Applicable |

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K110418

# Powder Free Nitrile Examination Gloves

# Attachment 13

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle or bird-like figure, composed of three curved lines.

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

Mr. Terence Lim Sin Kooi Head of Regulatory Affairs W.A Rubbermate Company, Limited 67/1 Bypass Road, Moo 4 Nongmaidaeng A. Maung Chonburi, THAILAND 20000

JUL 13 2011

Re: K110418

Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 29, 2011 Received: July 6, 2011

Dear Mr. Lim Sin Kooi:

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. Lim Sin Kooi

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 yours.

Anthony D. anton

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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Powder Free Nitrile Examination Gloves

Attachment 2

# INDICATIONS FOR USE

Applicant

W.A RUBBER MATE CO., LTD. 4 Ramkhamhaeng 19 (Chareonploy), Ramkhamhaeng Road, Huamark, Bangkapi, Bangkok 10240, Thailand

510(k) Number (if known)

K110418 *

Device Name

POWDER FREE NITRILE EXAMINATION GLOVES ( BLUE

Indications For Use

Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.

Concurrence of CDRH Office of Device Evaluation (ODE )

Prescription Use Per 21 CFR 801.109

× OR Over-The-Counter_

Rosie Pangulung

Vivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K110418