VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED

K982257 · Taian Plastics Products (Jingxing) Co., Ltd. · LYZ · Aug 3, 1998 · General Hospital

Device Facts

• Record ID: K982257
• Device Name: VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
• Applicant: Taian Plastics Products (Jingxing) Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 3, 1998
• 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Vinyl patient examination gloves; disposable; worn on examiner's hand or finger; intended to provide barrier protection against contamination between patient and examiner; used in clinical or medical settings; non-sterile; pre-powdered.

Clinical Evidence

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

Technological Characteristics

Vinyl material; pre-powdered; disposable; non-sterile; form factor is a hand-worn glove.

Indications for Use

Indicated for use as a disposable medical glove 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### માણ 3 1098

Mr. Chin-Yu Lin ·President Taian Plastic Products (Jingxing) Co., Ltd. The North of Beishimen Village, Xiaozuo Town Jingxing Country, Shijiazhuang City Hebei 050306, CHINA

K982257 Re : Vinyl Patient Examination Gloves Trade Name: Pre-Powdered Requlatory Class: I Product Code: LYZ Dated: June 20, 1998 Received: June 26, 1998

Dear Mr. Lin:

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 reqistration, 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 -----requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{1}------------------------------------------------

Page 2 - Mr. Lin

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

This letter will allow you to begin marketing your device as The FDA described in your 510 (k) premarket notification. 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 requlation (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/dsmamain.html".

Sincerely yours,

s. Sutman for

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

Enclosure ... .................

{2}------------------------------------------------

# TAIAN PLASTIC PRODUCTS (JII THE NORTH OF BEISHIMEN VILLAGE, XIAOZUO TOW JINGXING COUNTRY, SHIJIAZHUANG CITY

Image /page/2/Picture/4 description: The image is a black and white logo. The logo is a stylized plant with three leaves. The word "TAIAN" is written vertically down the center of the plant. The logo is surrounded by a square border.

### HEBEI 050306, CHINA TEL: [phone] E-MAIL: [e-mail] FAX: [phone],

## INDICATION FOR USE STATE

APPLICANT: Taian Plastic Products (Jingxing) Co., Ltd. 510 (K) Number (if known):

Device Name: Vinyl Patient Examination Gloves- Pre-powdered

Indication For Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Otin S. him

(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Devices

510(k) Number K982257

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter X

(Optional Format 1-2-96)