EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

K992175 · Ultrawin Sdn Bhd · LYY · Sep 24, 1999 · General Hospital

Device Facts

• Record ID: K992175
• Device Name: EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
• Applicant: Ultrawin Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

Extra-Care Powder-Free Polymer Coated Latex Patient Examination Glove; disposable device worn on examiner's hand; serves as protective barrier to prevent cross-contamination between patient and examiner; used in clinical settings; non-sterile; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; polymer coated; powder-free; disposable; non-sterile; patient examination glove form factor.

Indications for Use

Indicated for use as a disposable medical glove worn by healthcare examiners to prevent cross-contamination between the patient and the 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract design of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Ms. Melanie Lim Marketinq Executive Ultrawin Sdn. Bhd. Lot 2, Pesiaran Perindustrian Kanthan 2 31200 Chemor, Perak Darul Ridzuan Malaysia

K992175 Re : Extra-Care Latex Patient Examination Glove, Trade Name: Powder-Free Polymer Coated Requlatory Class: I Product Code: LYY Dated: July 26, 1999 Received: Auqust 16, 1999

Dear Ms. Lim:

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 aqainst 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 Regulations, 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 requlatory action. In addition, FDA may publish further announcements 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 through 542 of

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

Paqe 2 — Ms. Lim

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 requlation 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 Radioloqical Health

Enclosure

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

Page

## 3.0 Indications for Use Statement

## INDICATIONS FOR USE

| Applicant | Ultrawin Sdn Bhd |
|--------------------------|----------------------------------------------------------------------------|
| 510(k) Number (if known) | K992175 |
| Device Name | Extra-Care Powder Free Latex Patient Examination Glove -<br>Polymer Coated |

Indications For Use :

・

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

| | Concurrence of CDRH Office of Device Evaluation (ODE) |
|--------------------|------------------------------------------------------------------------|
| | <img alt="signature" src="signature.png"/> |
| | (Division Sign-Off) |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | K 992175 |
| Prescription Use | OR Over-The-Counter <span style="text-decoration: underline;">X</span> |
| Per 21 CFR 801.109 | |

Ultrawin Sdn Bhd

Lot 2, Pesiaran Perindustrian Kanthan 2, 31200 Chemor, Perak Darul Ridzuan, Malaysia

Tel No 605 201 3888 Fax No 605 201 1818