NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES

K024174 · General Gloves Corp. · LYZ · Jan 28, 2003 · General Hospital

Device Facts

• Record ID: K024174
• Device Name: NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
• Applicant: General Gloves Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A vinyl 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

Powder-free vinyl examination glove; disposable; worn on examiner's hand or finger. Primary function: barrier protection to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical or medical settings by healthcare professionals. Device provides physical barrier; no active components or electronic processing.

Clinical Evidence

No clinical data provided; device is a standard patient examination glove.

Technological Characteristics

Vinyl material; powder-free; disposable; non-sterile; Class I medical device; Product Code LYZ.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on hands or fingers 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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JAN 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

-Mr. John Chen Chief Engineer General Gloves Corporation No. 25, Pei Ma, 16 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien. TAIWAN 733, R.O.C.

Re: K024174

Trade/Device Name: Powder Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 12, 2002 Received: December 18, 2002

Dear Mr. Chen:

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.

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## Page 2 - Mr. Chen

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 (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.

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 vour 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/dsma/dsmamain.html

Sincerely yours,

Susan Ruane

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image shows the logo for General Gloves Corp. The logo consists of a stylized letter G on the left, followed by the text "GENERAL GLOVES CORP." in bold, sans-serif font. Below the company name, there is some text in a different language, possibly Chinese.

涌用手套國際股份有限公

No. 25, Pei Ma, 16 Lin, Tung Chung Village, Tung Shan Hsiang, 台南縣東山鄉東中村16鄰北馬25號TEL:[phone]-7,FAX:(06)680-

## 024174 510(k) NUMBER (IF KNOWN):

DEVICE NAME: POWDER FREE VINYL EXAMINATION GLOVES

## STATEMENT OF INDICATIONS FOR USE [ 807.92 (a) (5) ].

A vinyl 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over-The-Counter-Use **_**
(Per 21 CFR 801.109) (Optional Format 1-2-96)

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

510(k) Number: K024174