DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES

K974334 · Hong Huang Tang Industrial Co., Ltd. · LYZ · Jan 9, 1998 · General Hospital

Device Facts

• Record ID: K974334
• Device Name: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
• Applicant: Hong Huang Tang Industrial Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Disposable powder-free vinyl examination gloves with polyurethane coating; intended for use by healthcare personnel to provide a protective barrier; prevents cross-contamination between patient and clinician; worn on hands; single-use; non-sterile; manual application.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Vinyl with polyurethane coating; form factor: disposable examination glove; powder-free; non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread, rendered in black lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

Mr. Yu-Chang Hsiao ·President Hong Huang Tang Industrial Company, Ltd. No. 1-1, Nan Fung Road Funq Li Li, Yuan Li Chen Miao Li Hsien Taiwan, R.O.C.

Re : K974334 Disposable Powder Free Vinyl Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ November 15, 1997 Dated: November 18, 1997 Received:

Dear Mr. Hsiao:

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 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, Druq, 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 wou regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Hsiao

this response to your premarket notification submission does not affect any obligation you might have under sections 531 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. 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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Image /page/2/Picture/1 description: The image shows a logo for Hong Huang Tang Industrial Co., Ltd. The logo consists of a stylized symbol on the left, followed by the company name in both Chinese and English. The Chinese characters are "紘皇堂實業股份有限公司", and the English translation is "Hong Huang Tang Industrial Co., Ltd."

Attachment D

P.02

## Indication For Use Statement

510K Number(if known): K974334

Device Name: Disposable Powder Free Vinyl Polyurethane Coated Examination Gloves

Indication For Use:

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Truthfully Yours,

Yu Chang Hsiao
Yu-Chang Hsiao
President

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

Olin S. him

(Division Slan-Off) Division of Dental. CDRH, Office of Device Evaluation(ODE) and General Hospita F 1 O(k) Number Prescription Use OR Over-The-Counter Use __ X . (Per 21 CFR 801.109)

(Optional Format 1-2-96)