(71 days)
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Not Found
No
The 510(k) summary describes a surgeon's glove, a physical barrier device, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device, a surgeon's glove, is intended to provide a barrier against contamination, not to treat or cure a disease or condition.
No
Gloves are barrier devices, not diagnostic ones. Their purpose is to prevent contamination, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical product (gloves) made of natural latex, 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 provide a barrier on the hands in surgical settings. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The description confirms it's a glove, a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.
Product codes
KGO
Device Description
Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)
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
hands
Indicated Patient Age Range
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Intended User / Care Setting
surgical settings
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)
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Reference Device(s)
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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).
0
Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Mr. Ravi Abraham Managing Director Kanam Latex Industries PVT. Limited Ooppoottil Buildings K.K. Road, P.O. Box 28, Kottayam, Kerala-686 001 INDIA
Re: K013914
Trade/Device Name: Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: November 12, 2001 Received: November 27, 2001
Dear Mr. Abraham:
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
Page 2 - Mr. Abraham
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 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,
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KANAM LATEX INDUSTRIES PRIVATE LIMITED
ISO 9002 Certified Company
:
Reg. & Sales Office : Ooppoottil Buildings, P.O. Box No.28, K.K. Road, Kottayam - 686001. Kerala Ph. : 300343, Telex : 0888 - 281 Optl in. Fax No.91 - 481 - 563614 e-mail - kanam @ md2.vsnl.net.in website - www. kanamlatex.com
Factory : West Peruvitai, Pallavilai, Nagercoil - 629 003. Tamil Nadu, S. India. TNGST No. 6160681. CST : 461477 Dt.6.1.1987
Image /page/2/Picture/5 description: The image is a black and white logo for Surgicare. The logo features a pair of hands wearing surgical gloves. The hands are positioned in a way that suggests they are performing a delicate procedure or handling surgical instruments.
INDICATIONS FOR USE
APPLICANT
KANAM LATEX INDUSTRIES PVT LTD
510 (K) NO
DEVICE NAME
DERFREE LATEX SURGEON'S GLOVES WITH EIN CONTENT LABELING CLAIM (50 MICROGRAMS
INDICATIONS FOR USE.
A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other 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)
Bissell for Clin
vision Sign-Off) ാസ്ട്രോസ് വിവാഹം and General Hospital Devices * ( 18) Number -