(114 days)
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No
The document describes a surgical glove and contains no mention of AI or ML technology.
No
The device, a surgical glove, is intended to protect a surgical wound from contamination, not to treat or alleviate a medical condition.
No
The device is a glove intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly states it is a physical glove made of natural rubber, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Surgeon's Glove Function: A surgeon's glove is a barrier device worn by personnel to protect both the patient's wound and the wearer from contamination. It does not perform any diagnostic tests on samples from the body.
The provided information clearly describes a physical barrier device used during surgery, not a diagnostic test.
N/A
Intended Use / Indications for Use
A Surgeons glove is a 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
Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less Protein Gram
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2003
Mr. Joseph J. E. Pereira Primus Gloves Private Limited 14-A, Cochin Special Economic Zone Kakkanad, Cochin, Kerala, INDIA 682 037
Re: K030445
Trade/Device Name: Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less Protein Gram Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 5, 2003 Received: May 12, 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,
Patricio Cucurella/for.
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
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "Primus" in a stylized font. The word is surrounded by an oval shape that is formed by a thick, black line. The font is bold and slightly slanted, giving it a dynamic appearance. The overall design is simple yet eye-catching, with the word "Primus" being the central focus.
PRIMUS GLOVES (P) Limitea
Plot No. 14-A, Cochin Special Economic Zone, European Office, Kakkanad, Cochin - 682 037, Kerala, India Tel: 91-484-2413063, 2413076, Fax: 91-484-2413089 Email : primusgl@vsnl.com; primusgloves@eth.net; primusgl@spect n.net.in Fax:+ 49 - 451 - 5823541 www.primusg
Goldberg 16, D-23562, Lubeck, Germany Tel + 49 - 451 - 5823540 s.com Email: Primusgermany@aol.com
K0 30445
ENCLOSURE-II
INDICATIONS FOR USE
PRIMUS GLOVES PRIVATE LIMITED APPLICANT :
510 (k) NO ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------:
:POWDERFREE LATEX MICROSURGERY GLOVES BROWN COLOR DEVICE NAME
INDICATIONS FOR USE.
A Surgeons glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Qis S. Ps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental I
510(k) Number: K030445