(397 days)
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.
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.
I am sorry, but the provided text does not contain the detailed study information required to answer your request about acceptance criteria and device performance for the "latex surgeon's sterile, powdered gloves."
The document primarily consists of a 510(k) summary and an FDA clearance letter. While it mentions the device conforms to ASTM D3577-00a standard and lists some general "testing" categories (Shelf life, primary skin irritation test, guinea pig maximization test, toxicity), it does not provide:
- Specific acceptance criteria values.
- The reported device performance against those criteria.
- Details of any study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set information).
The "SUMMARY OF SUBSTANTIAL EQUIVALENCE" and "CONCLUSION" sections state that the device is substantially equivalent to predicate devices and meets minimum requirements, but they don't elaborate on the specific studies or data that demonstrate this.
Therefore, I cannot generate the requested table and study information based on the given input.
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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) SUMMARYPrepared 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 2693648 CH WILNISThe Netherlands | CONTACT:Mrs. M.J. van OostveenMrs. Y.A. ZwaartmanTel.: 00 31 297 282101Fax: 00 31 297 288316 |
| PREDICATEDEVICES | K014278 Brightway Gloves, IndiaK021065 Primus Gloves Private Ltd., India | |
| DEVICEDESCRIPTION | The ROMED surgeon's gloves are made of natural rubber, sterile andpowdered with USP absorbable dusting powder. E.P. content is less than100 µg/gm.Surgeon's gloves are in conformity with ASTM D3577-00a standard. | |
| INDICATIONS FORUSE | The ROMED surgeon's sterile powdered gloves is a single use disposabledevice made of natural rubber intended to be worn by operating roompersonnel to protect a surgical wound from contamination. | |
| TESTING | Shelf life, primary skin irritation test, guinea pig maximization test, toxicity | |
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The ROMED surgeon's sterile and powdered gloves are substantiallyequivalent to the predicate devices in intended use and principles ofoperation | |
| CONCLUSION | Based on the information presented, Van Oostveen Medical B.V. believesthat the proposed surgeon's gloves meet the minimum requirements thatare considered acceptable for its intended use and is substantiallyequivalent to other currently marketed gloves |
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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.
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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.
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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
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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)
§ 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).