(104 days)
Not Found
Not Found
No
The summary describes standard surgical gloves and contains no mention of AI or ML technology.
No
The device, a surgeon's glove, is intended to protect a surgical wound from contamination, which is a preventative measure rather than a therapeutic one (treatment or cure of a disease/condition).
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly indicates a physical product (gloves) and does not mention any software components.
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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a sterile surgeon's glove with specific material properties (polymer coated, powder-free, latex, protein content). This aligns with a medical device used for protection and hygiene, not for diagnosing a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Polymer coated, Powderfree Sterile Surgeon's Glove is a medical device, specifically a surgical glove, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.
Product codes
KGO
Device Description
POWDERFREE LATEX SURGEON'S GLOVES POLYMER COATED STERILE Contains 50 micrograms or less of Total water extractable protein per gram
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room Personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2004
Mr. Ravi Abraham Managing Director Kanam Latex Industries Private Limited P.O. Box No. 28 Oopoottil Building, K.K. Road Kottayam - 686 001, Kerala, INDIA
Re: K033564
Trade/Device Name: Powder Free Latex Surgeon's Gloves Polymer Coated Sterile, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 3, 2004 Received: February 6, 2004
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 approvisions 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 (1 Writ), it may be days of Federal Regulations, Title 21, Parts 800 to 898. In your deview to roublish 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. or the Fiel of 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 und libing (21 cos i forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as 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) Fine reter 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 maj of and 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,
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
2
ENCLOSURE-II
INDICATIONS FOR USE
| APPLICANT | KANAM LATEX INDUSTRIES PRIVATE LTD |
|---|---|
| 510 (K) NO | K033564 |
| DEVICE NAME | POWDERFREE LATEX SURGEON'S GLOVES |
| POLYMER COATED STERILE Contains | |
| 50 micrograms or less of Total water extractable protein per gram |
INDICATIONS FOR USE.
The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-C (21 CFR 807
| Counter Use | |
|---|---|
| 7 Subpart C) | ✓ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susanna Baruch
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number
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