SURGEON POWDER-FREE GLOVES, LATEX, STERILE
Device Facts
| Record ID | K992679 |
|---|---|
| Device Name | SURGEON POWDER-FREE GLOVES, LATEX, STERILE |
| Applicant | Wear Safe Malaysia Sdn. Bhd. |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Oct 21, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
A Surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Story
Surgeon's powder-free sterile latex gloves; worn by operating room personnel; barrier protection for surgical wounds; prevents contamination between patient and clinician; manufactured by Wear Safe Malaysia.
Clinical Evidence
Bench testing only.
Technological Characteristics
Material: Natural latex rubber; Form factor: Sterile, powder-free surgeon's gloves; Class I medical device.
Indications for Use
Indicated for use by operating room personnel to protect surgical wounds from contamination during surgical procedures.
Regulatory Classification
Identification
A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Ms. Danielle Cottet Quality Controller Wear Safe Malaysia Lot 1, Leboh Hishamuddin Satu North Klang Straits Industrial Area 42000 Port Klang Selangor Darul Ehsan, West Malaysia
Re: K992679 Latex Surqical Gloves Powder-Free Trade Name: Chlorinated Regulatory Class: I Product Code: KGO Dated: July 30, 1999 Received: August 10, 1999
Dear Ms. Cottet:
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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 regulations 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) 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
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Page 2 - Ms. Cottet
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 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 leqally 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Kj Alutrist
Timothy A. II atows 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/0 description: The image shows the logo for Wear Safe Malaysia (WSM). The logo has the letters WSM in large bold font, with the words "WEAR SAFE MALAYSIA" underneath. To the right of the letters is a symbol that looks like a plus sign. The text below the logo says "(Formerly known as WUHRLIN SOPLAMED (M) SDN. BHD.)" and "SDN. BHD. (204396-X)".
ANNEX 1
Page 01 of 01
## 510 (k) Number (if known) : K992679
Device Name :
## SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES
Indications For Use :
A Surgeon's glove is a device made of natural or synthetic rubber * intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presription Use __
OR
Over-The -Counter Use
(Per 21 CFR 801.109)
Qlin S. Lin
(Optional format 1-2-96)
(Division Sign-Off Division of Da ntal, Infe and General Hos 510(k) Number
