SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW

K992979 · Shanghai Poseidon Plastic Products Co., Ltd. · LYZ · Feb 9, 2000 · General Hospital

Device Facts

• Record ID: K992979
• Device Name: SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
• Applicant: Shanghai Poseidon Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 9, 2000
• 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable synthetic vinyl examination glove; worn on examiner's hand or finger; provides barrier protection to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical or general medical settings by healthcare professionals. Device is non-sterile, powder-free, and yellow in color.

Clinical Evidence

No clinical data provided; device relies on established material properties for examination gloves.

Technological Characteristics

Synthetic vinyl material; powder-free; yellow color; 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 U.S. Department of Health & 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 image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2000 FEB

Shanqhai Poseidon Plastic Products Company, Ltd. c/o Ms. Lara N. Simmons Official Correspondent Shanqhai Poseidon Plastic Products Company, Ltd. Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060-4486

Re : K992979 Shanghai Poseidon Powder-Free Synthetic Trade Name: Vinyl Examination Gloves Regulatory Class: I Product Code: LYZ Dated: January 7, 2000 Received: January 10, 2000

Dear Ms. Simmons:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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

Page 2 - Ms. Simmons

Please note: this response to your the Federal Register. 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 findinq 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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}------------------------------------------------

Page 1 of 1

| 510(k) Number (if known): | K992979 |
|---------------------------|--------------------------------------------------------|
| Device Name: | Powder-Free Synthetic Vinyl Examination Gloves, Yellow |

Indications For Use.

A 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)

Concu Tence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Oks. him

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

4