(397 days)
Not Found
No
The device description and intended use clearly describe a standard surgical glove made of natural rubber, with no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The document describes a surgical glove intended for protection, not for treating or preventing a disease or condition.
No
Explanation: The device is described as a surgical glove intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical medical device (surgical gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the material (natural rubber), sterility, and powdering. It doesn't mention any components or processes related to analyzing samples from the human body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens such as blood, urine, or tissue to diagnose diseases, monitor conditions, or screen for health issues. This device does none of those things.
The device described is a surgical glove, which is a Class II medical device used for protection and barrier purposes.
N/A
Intended Use / Indications for Use
The ROMED surgeon's sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The ROMED surgeon's gloves are made of natural rubber, sterile and powdered with USP absorbable dusting powder. E.P. content is less than 100 µg/gm. Surgeon's gloves are in conformity with ASTM D3577-00a standard.
The ROMED surgeon's gloves are made of natural rubber, sterile and powdered. The ROMED surgeon's gloves are powdered with absorbable dusting powder USDP corn starch as the donning lubricant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Shelf life, primary skin irritation test, guinea pig maximization test, toxicity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K023139'. The characters are written in black ink on a white background.
Dossier: latex surgeon's sterile, powdered gloves
Page 4 of 28
SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS |||
Van Oostveen Medical B.V. 510(k): Surgeon's gloves
| | 510(k) SUMMARY
Prepared August 2002 | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| TRADE NAME | ROMED latex surgeon's gloves, sterile, powdered | |
| GENERIC NAME | Surgeon's gloves | |
| CLASSIFICATION | Class I (21 CFR 878.4460) | |
| SUBMITTED BY | Van Oostveen Medical B.V.
Herenweg 269
3648 CH WILNIS
The Netherlands | CONTACT:
Mrs. M.J. van Oostveen
Mrs. Y.A. Zwaartman
Tel.: 00 31 297 282101
Fax: 00 31 297 288316 |
| PREDICATE
DEVICES | K014278 Brightway Gloves, India
K021065 Primus Gloves Private Ltd., India | |
| DEVICE
DESCRIPTION | The ROMED surgeon's gloves are made of natural rubber, sterile and
powdered with USP absorbable dusting powder. E.P. content is less than
100 µg/gm.
Surgeon's gloves are in conformity with ASTM D3577-00a standard. | |
| INDICATIONS FOR
USE | The ROMED surgeon's sterile powdered gloves is a single use disposable
device made of natural rubber intended to be worn by operating room
personnel to protect a surgical wound from contamination. | |
| TESTING | Shelf life, primary skin irritation test, guinea pig maximization test, toxicity | |
| SUMMARY OF
SUBSTANTIAL
EQUIVALENCE | The ROMED surgeon's sterile and powdered gloves are substantially
equivalent to the predicate devices in intended use and principles of
operation | |
| CONCLUSION | Based on the information presented, Van Oostveen Medical B.V. believes
that the proposed surgeon's gloves meet the minimum requirements that
are considered acceptable for its intended use and is substantially
equivalent to other currently marketed gloves | |
1
Dossier: latex surgeon's sterile, powdered gloves
DEVICE DESCRIPTION IV
The ROMED surgeon's gloves are made of natural rubber, sterile and powdered. The ROMED surgeon's gloves are powdered with absorbable dusting powder USDP corn starch as the donning lubricant.
The ROMED surgeon's sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Ms. Y vonne Zwaartman Van Oostveen Medical B.V. Herenweg 269 3648 CH Wilnis Holland
Re: K023139
Trade/Device Name: Romed Latex Surgical Gloves, Powdered, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 9, 2003 Received: October 14, 2003
Dear Ms. Zwaartman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -Ms. Zwaartman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.
Susan Ramer
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) number (if known): _ KC23 139
[Device name: surgeon's gloves, sterile, powdered
Indications for use:
The ROMED surgeon sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Patricia A. Helen Branch, IncB
Division Sign-Off) ision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023137
(PLEASE DO NOW WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)