(36 days)
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Not Found
No
The summary describes a standard surgical glove and contains no mention of AI or ML technology.
No
The device is a surgeon's glove, intended to protect a surgical wound from contamination, which is a preventative measure rather than a direct therapeutic intervention.
No
The device is described as a "surgeon's glove" intended to protect a surgical wound from contamination, which is a protective barrier, not a tool for diagnosis.
No
The device description clearly states it is a physical product (gloves) made of rubber, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the material and form of the glove, which is consistent with a physical barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This surgeon's glove does not fit that description.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
Product codes
KGO
Device Description
Pre-Powdered Sterile Latex Surgeon's Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Mr. Joseph J. E. Pereira Director Primus Gloves Private Limited 14 A, Cochin Special Economic Zone Kakkanad, Cochin, Kerala, INDIA 682 030
Re: K021065
Trade/Device Name: Pre-Powdered Sterile 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: March 22, 2002 Received: April 2, 2002
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.
1
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 not invall at 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 i carrat 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 s rotty promate ted 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Pattare Circuit/fa
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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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 encloses the word. The font is bold and appears to be handwritten. The image is in black and white.
PRIMUS GLOVES (P) Limited
Plut No. 14-A, Cochin Special Economic Zone. European Office: Kakkanad, Cochin - 682 037, Kerala, India Goldberg 16, D-23562, Tel: 91-484-421983, 423530, Fax: 91-484-424033 Lubeck, Germany Email : primusgl@vsnl.com; primusgloves@eth.net; Tel + 49 - 451 - 5823540 primusgl@spectrum.net.in Fax:+ 49 - 451 - 5823541
www.primusgloves.com Email: Primusgermany@aol.com
ENCLOSURE-II
INDICATIONS FOR USE
APPLICANT
PRIMUS GLOVES PRIVATE LIMITED
510 (k) NO
KO21065
DEVICE NAME
pre-POWDERED LATEX SURGEON'S Sterile pre-POWDERED LAIEX SORGEON 3 ram one less of Tofol Water Extract able Profess Per Gran
INDICATIONS FOR USE.
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by 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, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Qhia S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -