(78 days)
A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.
POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-free Latex Surgeon's Gloves." It focuses on the regulatory approval process and does NOT contain information about acceptance criteria, study details, or device performance against specific metrics as would be typically found in a clinical or performance study report for AI/medical imaging devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text. The document is a regulatory approval letter, not a scientific study report.
The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, training set details) is not present in this type of FDA correspondence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Mr. Joseph J. E. Pereira Managing Director Sanrea Healthcare Private Limited Plot No. 14-C, Cochin Special Economic Zone, Kakkanad, Cochin-682037 Kerala. INDIA
Re: K023912
Trade/Device Name: Powder-free Latex Surgeon's Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: January 15, 2003 Received: January 21, 2003
Dear Mr. Pereira:
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 - Mr. Pereira
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 (QS) 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 you 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 Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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ENCLOSURE-II
INDICATIONS FOR USE
APPLICANT
SANREA HEALTHCARE PRIVATE LIMITED
510 (k) NO
VC-20-112
DEVICE NAME
POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect
INDICATIONS FOR USE.
:
.
A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qùin S. Lin
Division Signsion of Anesthesiology, General Hospital, a Control, Dental De
510(k) Number. K023912
OR
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).