SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR

K992922 · Shijiazhuang Hongray Plastic Products Co., Ltd. · LYZ · Oct 6, 1999 · General Hospital

Device Facts

• Record ID: K992922
• Device Name: SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
• Applicant: Shijiazhuang Hongray Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 powdered vinyl synthetic examination gloves; worn on hands by healthcare personnel; serves as protective barrier to prevent cross-contamination between patient and clinician; used in clinical settings; non-sterile; single-use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Vinyl (polyvinyl chloride). Form factor: Disposable, powdered, white, synthetic examination glove. Non-sterile. Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer 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)

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or a caduceus without the staff, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1999

Mr. Gui-Xi Liu General Manaqer Shijiazhuang Hongray Plastic Products Co. Ltd. No. 135 Xinhua West Road Shijiazhuang City, Hebei Province CHINA

K992922 Re : Sensi-Pro, Disposable Powdered Vinyl Trade Name: Synthetic Examination Gloves Requlatory Class: I Product Code: LYZ Dated: August 8, 1999 Received: August 30, 1999

Dear Mr. Gui-Xi Liu

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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

Page 2 - Mr. Gui-Xi Liu

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 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 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" (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

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

Enclosure

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

## SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO.

No. 135 Xinhua West Road, Shijiazhuang City, Hebei Province, China Tel: [phone] 3634449 Fax: [phone] Attachment G Email: [e-mail]

## Indication For Use

| Applicant: | Gui-Xi Liu, Shijiazhuang Hongray Plastic Products Co., LTD. |
|------------|-------------------------------------------------------------|
|------------|-------------------------------------------------------------|

× 99 29 22 510K Number(if known):

Device Name: Disposable Powdered Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)

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,

刘贵荣

Gui-Xi Liu General Manager

(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 X | | |
|----------------------|----------------------------------------|---------|--|------------------------|--------------------------|--|
| (Per 21 CFR 801.109) | | | | | | |
| | | | | | (Optional Format 1-2-96) | |
| | (Division Sign-Off) | | | | | |
| | Division of Dental, Infection Control, | | | | | |
| | and General Hospital Devices | | | | | |
| | 510(k) Number | K992922 | | | | |