(48 days)
Not Found
No
The device is a surgical glove and the description and performance studies focus on material properties and physical characteristics, with no mention of AI/ML.
No
The device is a surgical glove, which is intended to protect a surgical wound from contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as "surgeon's gloves" intended to protect a surgical wound from contamination, not to diagnose a disease or condition. Its performance studies focus on physical properties and safety (irritation, sensitization), not diagnostic accuracy.
No
The device is a physical surgical glove made of synthetic rubber, 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 barrier function for infection control, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a surgical glove made of synthetic rubber. This is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the glove (irritation, sensitization, dimensions, strength, freedom from holes, powder residual), which are relevant to its function as a barrier and protective device, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
Esteem Ortho Polyisoprene Powder-Free Surgical Gloves are a disposable device made of synthetic rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Product codes
KGO
Device Description
Esteem Ortho Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They are offered powder-free and sterile.
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
hospitals and other healthcare facilities
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)
Performance Testing:
| Test: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Ultimate Elongation | |
| & Tensile Strength | Gloves meet requirements for rubber surgical gloves per |
| ASTM D3577. | |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free" |
| designation per ASTM D3577 tested using ASTM standard | |
| D6124, Standard test method for residual powder on medical | |
| gloves. Results generated values below 2mg of residual powder | |
| per glove. | |
| Clinical Data: | No clinical data was required. |
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.
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
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
SEP 1 5 2009
CardinalHealth
P102
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Cardinal Healthcare 222 LTD.
7/111 Moo 4, Highway 3331 Mabyangporn Pluakdaeng,
Rayong, 21140, Thailand |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: Tatyana Bogdan, RAC | Cardinal Health, Inc.
1500 Waukegan Road
McGaw Park, IL 60085 |
| Telephone: | 847-578-2325 |
| Date Summary Prepared: | June 12, 2009 |
| Product Trade Name: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Predicate Devices: | 1) Esteem Polyisoprene Powder-Free Surgical Gloves previously
cleared under K011721 (product code KGO);
2) Ultrafree Max Sterile Latex Powder-Free Surgical Gloves
previously cleared under K010862 (product code KGO). |
| Device Description: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves are
formulated using synthetic rubber latex. They are offered powder-
free and sterile. |
| Intended Use: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves are a
disposable device made of synthetic rubber that is intended to be
worn by operating room personnel to protect a surgical wound
from contamination in the environments within hospitals and other
healthcare facilities. |
| Substantial Equivalence: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves are
substantially equivalent to Esteem Polyisoprene Powder-Free
Surgical gloves in regard to intended use, sizes, design and product |
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
1
K092304
p2sf2
features; they both are made of synthetic rubber latex using similar manufacturing process and packaging.
Esteem Ortho Polyisoprene Powder-Free Surgical gloves are also substantially equivalent to Ultrafree Max Sterile Latex Powder-Free Surgical gloves in regard to physical characteristics, design and product features. Both gloves are intended for use as specialty orthopedic surgeon's gloves.
Performance Testing:
| Test: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Ultimate Elongation | |
| & Tensile Strength | Gloves meet requirements for rubber surgical gloves per |
| ASTM D3577. | |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free" |
| designation per ASTM D3577 tested using ASTM standard | |
| D6124, Standard test method for residual powder on medical | |
| gloves. Results generated values below 2mg of residual powder | |
| per glove. | |
| Clinical Data: | No clinical data was required. |
| Conclusion: | The Esteem Ortho Polyisoprene Powder-Free Surgical Gloves |
| meet the technological characteristics of ASTM D3577 and are | |
| substantially equivalent to predicate devices identified in this | |
| 510(k) summary. |
Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k)
2
Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three parallel lines that curve upwards and to the right, with a small circle at the bottom.
SEP = 5 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring MD 20993-0002
Cardinal Healthcare, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K092304
Trade/Device Name: Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 28, 2009 Received: August 31, 2009
Dear Mr. Devine:
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 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.
3
Page 2 - Mr. Devine
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. watson for
Susan Runner, D.D.S., M.A.
Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized bird-like graphic above the text "CardinalHealth". The graphic is made up of several curved lines that resemble wings. The text is in a sans-serif font and is black.
Indications for Use
510(k) Number (if known):
Device Name:
Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves
Indications for Use:
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula T. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page of
510(k) Number: K092304