POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)

K050122 · Smart Glove Corp. Sdn Bhd · LZA · Apr 18, 2005 · General Hospital

Device Facts

• Record ID: K050122
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
• Applicant: Smart Glove Corp. Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Powder-free nitrile examination glove; blue color; designed for medical use to prevent cross-contamination between patient and examiner. Device worn on examiner's hand during clinical procedures. Manufactured without thiuram, carbamate, or thiazole accelerators. Provides physical barrier protection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; blue color; accelerator-free (no thiuram, carbamate, or thiazole); disposable; non-sterile; patient examination glove (Class I, 21 CFR 880.6250).

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.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2005

Mr. Foo Khon Pu Manager Director Smart Glove Corporation SDN. BHD Lot 6487, Batu 5 ¾, Sementa, Jalan Kapar, 42100 Klang Selangor Darul Ehsan MALAYSIA

Re: K050122

Trade/Device Name: Powder Free Nitrile Examination Glove (Blue) (This Product Does not Contain Thiuram, and /or Carbamate and /or Thiazole) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 7, 2005 Received: April 11, 2005

Dear Mr. Pu:

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 mersure comments, 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 the Federal I vou, Drag, and Commay, therefore, market the device, subject to the general approvial applivans of the Act. The general controls provisions of the Act include controls providers of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (I MA), it may be subject to Back 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. Pu

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sheri Kunnas

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): K 0 5 0 1 2 2

Device Name: Powder Free Nitrile Examination Glove (Blue) (This product does not contain Thiuram, and/or Carbamate and/or Thiazole) Indications For Use:

> The glove is disposable and intended for medical purpose that is worn on the examiner's hand 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)

S. Liddington L/D 4/5/65

closer, General Hospital,

Kasaj22

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