NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE

K014284 · Formosa Glove Industrial Co., Ltd. · LZA · Feb 15, 2002 · General Hospital

Device Facts

• Record ID: K014284
• Device Name: NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
• Applicant: Formosa Glove Industrial Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Nitrile patient examination glove; disposable; powder-free; yellowish-white color. Worn by healthcare professionals during patient examinations to provide a protective barrier against contamination. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile material; powder-free; yellowish-white; disposable; non-sterile; Class I device (Product Code LZA).

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, enclosed in a circle. The text "HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 5 2002

Formosa Glove Industrial Company Limited C/O Dr. Tiang S. Chang 1016 Seward Avenue Westfield, New Jersey 07090

Re: K014284

Trade/Device Name: Nitrile Patient Examination Gloves, Powder-Free and Yellowish White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 22, 2001 Received: December 27, 2001

Dear Dr. Chang:

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 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.

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.

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#### Page 2 - Dr. Chang

You must comply with all the Act's requirements, including, but not limited to: registration You must colliply with an the Act 5 required (21 CFR Part 801); good manufacturing practices and listing (21 CFR Pat 607), laceming (21 CFR Pat 820) 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 1 his letter will anow you to begin marketing your substantial equivalence of your device to 510(K) premiarket nothleation. The PBPICation 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 If you desire specific advice for your & in vitro diagnostic devices), please contact the and additionally 21 CFR Fall 607.10 Ion in the onelly, for questions on the promotion and Office of Comphance at (301) 391 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - - 639. advertising or your arritled, "Misbranding by reference to premarket Also, picase note the regulation one other general information on your responsibilities under notification (21CF ICPart 007.97). Oaks got Small Manufacturers, International and the Act may be obtained from the DPH.orger [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Chena-Ch nin-Ya 1.hinet.net

### Indications for Use

Formosa Glove Industrial Co., Ltd. Applicant:

KO14294 510(k) Number (if known):

Device Name: Nitrile Patient Examination Glove, Powder-free and vellowish white

Indications for Use:

A 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.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

Over the Counter Use

(Optional Format 1-2-96)

Olim S. Lin

്തിടion Sign-Off) Asion of Dental, Infection Control, General Hospital Devic ""(k) Number .

FACTORY:NO.10-8,MA-KUO-LI,MATOU TOWN,TAINAN HSIEN,TAIWAN,R.O.C. 1061570-1885-6 FAX [phone]