(24 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is intended to protect a surgical wound from contamination, not to treat a disease or condition or restore function.
No
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is described as surgical gloves made of synthetic rubber, which are physical hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Intended Use: The intended use of this device is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier device used externally during a surgical procedure.
- Device Description: The description reinforces that these are surgical gloves intended for protection during surgery.
There is no indication that this device is used to analyze samples from the body or provide diagnostic information.
N/A
Intended Use / Indications for Use
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
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): 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.
Not Found
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).
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).
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MAY 1 1 1998
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Checklist
Section 21.0
- 510 (k) Summary [1]
- Ansell Perry Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 330-833-6213 Fax:
James R. Chatterton Contact: Telephone: 330-833-2811 330-833-6213 Fax:
September 10, 1997
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves [3] Trade Name: Surgical Gloves, Green Polyurethane Common Name: Surgeon's Glove Classification Name:
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of [4] ASTM D 3577, Type 2.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications (5) for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices િ intended to be worn by operating room personnel to protect a surgical wound from contamination.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are summarized with the following [7] technological characteristics compared to ASTM or equivalent standards.
Characteristics Standard Dimensions Meets ASTM D 3577 Physical Properties Meets ASTM D 3577, Type 2
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | | | |998
Mr. James R. Chatterton Vice President Regulatory Affairs, Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646
K981392 Re : Elite Mark IV Sterile Powder-Free Trade Name: Polyurethane Synthetic Surgical Gloves (Green) Requlatory Class: I Product Code: KGO Dated: April 9, 1998 Received: April 17, 1998
Dear Mr. Chatterton:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800-to 895. A ---substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify *such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Mr. Chatterton
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041, or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3.0 Indications for Use Statement:
INDICATIONS FOR USE
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Surgeon's Glove, powder free, polyurethane, green color Device Name: _
Indications For Use:
A device made of 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)
(Division Off) Heeze 1.milk for China 5. Tin PR
Divisional, Infection Control,
and General Hospital Devices
510(k) Number κ981372
D
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter