VINYL EXAMINATION GLOVES, PREPOWDERED USP

K984094 · Trans Ancient Products Co., Ltd. · LYZ · Jan 14, 1999 · General Hospital

Device Facts

• Record ID: K984094
• Device Name: VINYL EXAMINATION GLOVES, PREPOWDERED USP
• Applicant: Trans Ancient Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Patient Examination Gloves A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Vinyl examination gloves, prepowdered, intended for use by healthcare personnel as a protective barrier. Worn on hands to prevent cross-contamination between patient and provider. Device is a disposable, single-use physical barrier.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Vinyl material; prepowdered; disposable; non-sterile; Class I medical device.

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier to prevent cross-contamination between the personnel and the patient.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Mr. Joanna Lee Office Manager Trans Ancient Products Co. Ltd. No. 10-3, Lane 73, Sec. 2, Chung Hua East Road Tainan, TAIWAN R.O.C.

K984094 Re : Vinyl Examination Gloves, Prepowdered USP Trade Name: Requlatory Class: I Product Code: IYZ December 7, 1998 Dated: December 11, 1998 Received:

Dear Ms. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Lee

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamafin.html".

Sincerely yours,

Timothy A. Ulatowski

Timot A. Ulatowski Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.0 Indications for Use Statement; Include the following or cquivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

| Applicant: | Trans Ancient Products Co., LTD. |
|---------------------------|--------------------------------------------|
| 510(k) Number (if known): | K984094 |
| Device Name: | Vinyl Examination Gloves, Prepowdered, USP |

Indications For Use:

Patient Examination Gloves

A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

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

## Concurrence of CDRH Office of Device Evaluation (ODE)

George A. Miller for Chin S. Tiong, Ph D

(Division Sign-Off) Division of Dental, Infection Control and General Hospital I 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

(Optional Formar 1-2-96)

Р.З

* For a new submission, do NOT fill in the 510(k) number blank.