NITRILE EXAMINATION GLOVES, POWDER FREE

K051333 · Shun Thai Rubber Gloves Industry Co., Ltd. · LZA · Jul 22, 2005 · General Hospital

Device Facts

• Record ID: K051333
• Device Name: NITRILE EXAMINATION GLOVES, POWDER FREE
• Applicant: Shun Thai Rubber Gloves Industry Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile examination gloves; powder-free; disposable. Worn on examiner's hands; provides physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals or general users. Device functions as a protective barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; disposable; non-sterile; physical barrier form factor. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner in clinical or general settings.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 2 2005

Shun Thai Rubber Gloves Industry Company, Limited c/o Mr. Anan Jetsadawisut Managing Director 238/1 Ratchada-Pisek Road Huay-Kwang, Bangkok 10310 THAILAND

Re: K051333

Trade/Device Name: Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 16, 2005 Received: June 28, 2005

Dear Mr. Jetsadawisut:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass saled in the encrease, 1976, the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Fror (110) that the device, subject to the general controls provisions of the Act. The r ou may, dierelore, mainer of the Act include requirements for annual registration, listing of general voltable provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clubsition (600 were virols. 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 be found in the Outseements concerning your device in the Federal Register.

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Page 2 -- Mr. Jetsadawisut

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualted on a cadevice complies with other requirements of the Act that IDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations and using, but not limited to: registration and listing (21 comply with an the Act 31equirements, as a manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons Described in your Section 110(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA mismig of casification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at vice for your as [phone]. Also, please note the regulation entitled, Comaci the Office of Complaned at (217) and Station" (21CFR Part 807.97). You may obtain "Misbrailuling by relevence to premantee notifications of Sciftion the Division of Small other general information on your responsive Assistance at its toll-free number [phone] or Manufacturers, International and Ochbanker v.ltwww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sulte Y. M. chane DmD

Chiu Lin, Ph.D. 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

510(k) Number (if known): K051333

Device Name: Nitrile Examination Gloves, Powder Free

Indications for Use: This glove is disposable and intended for medical Indiodions for over on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use (21 CFR 801 Subpart C)

لقترة بتربع بين

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheila H. Murphy MD 7/21/05

(Division Sign-Off) Division of Anesthesiology, General h Infection Control, Dental D

510(k) Number: K051333

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