EXTRA-CARE POWDER-FREE EXAMINATION GLOVE

K983175 · Ultrawin Sdn Bhd · LYY · Oct 13, 1998 · General Hospital

Device Facts

• Record ID: K983175
• Device Name: EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
• Applicant: Ultrawin Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Oct 13, 1998
• 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 Latex Powder-Free Examination Glove; disposable device worn on examiner's hand; prevents contamination between patient and examiner; used in clinical settings; provides barrier protection.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; powder-free; disposable; examination glove form factor.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 13 1998

Mr. Siew Hoe Mah ·Manaqer Ultrawin Sdn. Bhd. Lot 2, Pesiaran Perindustrian Kanthan 2, 31200 Chemor, Perak Darul Ridzuan, MALAYSIA

Re : K983175 Trade Name: Extra-Care Latex Powder-Free Examination Glove Regulatory Class: I Product Code: LYY Dated: September 8, 1998 September 10, 1998 ... ... ... Received:

Dear Mr. Mah:

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 qeneral controls provisions of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

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Page 2 - Mr. Mah

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 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 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,

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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## Indications for Use Statement 3.0

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## INDICATIONS FOR USE

| Applicant | Ultrawin Sdn Bhd |
|--------------------------|----------------------------------------------------|
| 510(k) Number (if known) | K983175 |
| Device Name | Extra-Care Patient Examination Glove - Powder Free |
| 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)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K983175 |
|---------------|---------|
|---------------|---------|

| Prescription Use | | OR | Over-The-Counter | X |
|------------------|--|----|------------------|---|
|------------------|--|----|------------------|---|

Per 21 CFR 801.109