(88 days)
Not Found
Not Found
No
The summary describes a surgical glove and contains no mention of AI or ML technology.
No
Explanation: This device is a surgeon's glove, intended to provide a barrier against contaminants. It does not treat or cure any medical condition, nor does it restore, modify, or replace any bodily function.
No
Explanation: The device is a surgeon's glove, intended as a barrier. It does not perform any diagnostic function.
No
The device is a physical glove, not software. The description clearly states it is a "powder-free sterile surgeon's glove" made of "Poly-Isoprene".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "powder-free sterile surgeon's glove" intended to be worn on the hands as a barrier. Its function is to protect the user and the patient from contamination, not to analyze a sample from the body to provide diagnostic information.
The information provided about the device's material, sterility, and intended use in surgical settings all point to it being a medical device used for barrier protection, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement
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
Not Found
Intended User / Care Setting
surgical settings
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): 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.
Not Found
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
Image /page/0/Picture/1 description: The image shows a stylized logo of the United States Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line forming the staff. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2006 MAR
Ms. Kathleen Harris Regent Medical Americas, Limited Liability Company 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092
Re: K053442
K005442
Trade/Device Name: Biogel Skinsense Poly-Isoprene Powder-free Surgeon's Glove With Non-pyrogenic statement
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 23, 2006 Received: February 24, 2006
Dear Ms. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becally of the device is substantially equivalent (for the referenced above and have determined the accessful marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to tray been reclassified in accordance with the provisions of Amendinents, or to devices that in the e Act (Act) that do not require approval of a premarket nic redelar Pood, Drug, and Cosmetic . . 00 (126) - 16) .
approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include confors provisions of the Fist." tion and 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 If your device is classified (000 about on trols. Existing major regulations affecting (FMA), It may of subject to Such additions, Title 21, Parts 800 to 898. In your device can oc found in the bous nouncements concerning your device in the Federal Register. ﺐ
1
Page 2 - Ms. Kathleen Harris
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 (OS) 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 continue 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 (240) 276-0115. 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 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,
Susan Rumm
Chia-Lin, Ph.D.
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):
Device Name: Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement
Indications For Use:
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Over-The-Counter Use __ AND/OR Prescription Use × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Shula M. Murphy D 5/2/06
y General H.s,
Services
K053442