(114 days)
Not Found
Not Found
No
The summary describes a surgical glove and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or diagnose a disease or condition.
No
The device description indicates it is a surgical glove worn by personnel to protect a surgical wound from contamination, which is a protective function, not a diagnostic one.
No
The device is described as surgical gloves, which are a physical hardware product, 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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description 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
The device is clearly described as a surgical glove, which falls under the category of medical devices used for protection and barrier purposes in a surgical setting.
N/A
Intended Use / Indications for Use
The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile 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
Powder-Free, Polychloroprene Surgical Gloves with Aloe Vera and Vitamin E, Sterile
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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
Public Health Service
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anil Taneja Vice President PT. Medisafe Technologies JL. Batang Kuis, Gg. Tambak Rejo, Pasar IX Desa Buntu Bedimbar, Tanjung Morawa-20362 Medan-Sumatera Utara INDONESIA
Re: K042567
Trade/Device Name: Synthetic Polychloroprene Surgical Glove with Aloe Vera and Vitamin E, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 24, 2004 Received: November 29, 2004
Dear Mr. Taneja:
We have reviewed your Section 510(k) premarket notification of intent to market the device we mayo roverved your betermined 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 mersule commerce prior sthat have been reclassified in accordance with the provisions of Amendinens, or to are roses and Cosmetic Act (Act) that do not require approval of a premarket the Federal I 600; Drag, Drag, therefore, market the device, subject to the general approvin uppression (s) the Act. The general controls provisions of the Act include controls provisions of the Fish - 110 - Jisting 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 If your device is classinod (oos as olditional controls. Existing major regulations affecting (1 Mrs), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Taneja
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advace that 22 a determination that your device complies with other requirements moan that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outhar statuse the requirements, including, but not limited to: registration r ou inton compry war 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF read 001), systems (QS) regulation (21 CFR Part 820); and if requirences as set forth in the quality sion 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) I mis letter will and in yourse 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), 11 you don't the Office of Compliance at (301) 594-0115. 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 overn 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,
Qurs
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
Indications for Use
510(k) Number (if known): K042567
Device Name: Powder-Free, Polychloroprene Surgical Gloves with Aloe Vera and Vitamin E, Sterile
Indications For Use:
The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile _ is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suste Michain DMD.
sion of Anesthesiology, Gene Infection Control, Dental D
510(k) Number