UNIJECT SURGICAL GLOVES
Device Facts
| Record ID | K970160 |
|---|---|
| Device Name | UNIJECT SURGICAL GLOVES |
| Applicant | Uniject Gloves , Ltd. |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Jul 15, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the operating room personnel to protect a surgical wound from contamination.
Device Story
Surgeon's glove composed of natural or synthetic rubber; worn by operating room personnel during surgical procedures; acts as physical barrier to prevent contamination of surgical wounds; protects both patient and clinician.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Natural or synthetic rubber material; form factor is a surgeon's glove; intended for single use; non-sterile or sterile (implied by surgical 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JUL 15 1997
Uniject Gloves Ltd.
C/O Dr. Syed Baber
2920 Mumphrey Drive
Chal Mette, Louisiana 70043
Re: K970160
Trade Name: Uniject Powdered Latex Surgical Gloves
Regulatory Class: I
Product Code: KGO
Dated: April 29, 1997
Received: May 1, 1997
Dear Dr. Baber:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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 - Dr. Baber
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 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 (301) 594-4618. 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.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 Radiological Health
Enclosure
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UNIJECT GLOVES LTD.
JEBEL ALI RUE ZONE
DUBAI
INCORPORATED IN BRITISH VIRGIN ISLAND
# INDICATIONS FOR USE
Applicant : UNIJECT GLOVES LTD; JEBEL ALI, DUBAI (U.A.E)
510 K Number : K 9700160
Device Name : UNIJECT SURGICAL GLOVES
Indications for use : A surgeon's glove is device made of natural or synthetic rubber intended to be worn by the 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 Officer of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
Prescription Use
Per 21 CFR 801, 109
OR
Over-The-Counter
(Optional Format 1-2-96)
P.O. BOX 16901, JEBEL ALI, DUBAI - U.A.E.
TEL. : 00971-4-815235
FAX. : 00971-4-815232
ص.ب : ١٦٩٠١ : جبل علي ، دس - ا.ج.د.
تليفون : ٠٩٧١-٤١٥١٢٢
فاكس : ٠٩٧١-٤١٥١٢٢
