FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

K041391 · Hartalega Sdn Bhd · LZA · Jul 9, 2004 · General Hospital

Device Facts

• Record ID: K041391
• Device Name: FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Device Story

FreeForm Blue Powder Free Nitrile Examination Glove is a disposable, non-sterile nitrile glove. Designed for use in medical and dental settings by healthcare professionals to provide a protective barrier between the examiner and the patient, reducing the risk of cross-contamination. The device is worn on the hands during patient examinations or procedures. It functions as a physical barrier; no electronic or mechanical components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable examination glove. Color: Cornflower Blue. Powder-free. Non-sterile. No electronic components or software.

Indications for Use

Indicated for use as a disposable medical and dental 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2004

HARTALEGA Sdn. Bhd. C/O Mr. Tito Aldape Vice President, Regulatory and Scientific Affairs Microflex Corporation 2301 Robb Drive Reno, Nevada 89523

Re: K041391

Trade/Device Name: FreeForm Blue Powder Free Nitrile Examination Glove (Cornflower Blue) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 7, 2004 Received: May 25, 2004

Dear Mr. Aldape:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 vir 1), it a 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. Aldape

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. or the Frecor any - 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 und noting (2) - est 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) Frider notification. The FDA finding of substantial equivalence of your device to a promarketed 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), rt you decited 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/dsma/dsmamain.html

Sincerely yours,

Chin Lin, Ph.D.

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):_____________________________________________________________________________________________________________________________________________________

FreeForm Blue Powder Free Nitrile Examination Gloves (Cornflower Device Name:__________________________________________________________________________________________________________________________________________________________________ Blue)

Indications For Use:

The nitrile examination glove is a disposable device intended and dental purposes that The mirrite examiner's hand to prevent contamination between the patient and examiner.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Hulsey

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K041391