OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
Device Facts
| Record ID | K984064 |
|---|---|
| Device Name | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE |
| Applicant | Omni Intl., Inc. |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Jan 8, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
A glove to be worn by operating room personnel to protect a surgical wound from contamination.
Device Story
OmniGrip Latex Surgeons Gloves are powder-free, sterile, single-use devices designed for use by operating room personnel. The gloves serve as a protective barrier to prevent contamination of surgical wounds during procedures. They are worn by surgeons and surgical staff in clinical settings to maintain sterile fields and protect both the patient and the healthcare provider. The device is a passive barrier; it does not involve electronic inputs, algorithms, or software.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Material: Latex. Form factor: Surgical glove. Powder-free. Sterile. Single-use.
Indications for Use
Indicated for use by operating room personnel to protect surgical wounds from contamination.
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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8 1999 JAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William E. Patton Vice President Regulatory Affairs OmniGrace (Thailand) Ltd. 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla, 90250 THAILAND
Re : K984064 OmniGrip, Latex Surgical Glove, Powder-Free Trade Name: Requlatory Class: I Product Code: KGO Dated: November 12, 1998 Received: November 16, 1998
Dear Mr. Patton:
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 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 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. ਰ 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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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. Patton
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 (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" (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 (800) 638-2041 or (301) 443-6597 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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## OmniGrace (Thailand) LTD 510(k) Premarket Notification Surgeon Glove, Latex, Powder Free
November 12, 1998 Attachment II
## INDICATIONS FOR USE
Applicant : OmniGrace (Thailand) Ltd.
| Device Name: | OmniGrip Latex Surgeons Gloves, Powder Free |
|---------------------------|---------------------------------------------|
| 510(k) Number (if known): | K984064 |
Indications For Use :
A glove 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)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | Y984066 |
|---------------|---------|
|---------------|---------|
| Prescription Use | |
|---------------------|---|
| OR Over The Counter | X |
6
Per 21 CFR 801.109
