(64 days)
Not Found
No
The 510(k) summary describes standard surgical gloves and does not mention any AI or ML capabilities. The performance studies focus on material properties and physical characteristics, not algorithmic performance.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, sterile surgeon's gloves, is intended to protect a surgical wound from contamination, which is a prophylactic or protective function, not a therapeutic one.
No
The device is described as powder-free sterile surgeon's gloves, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is a physical product (surgical gloves) and the 510(k) summary describes material composition, physical characteristics, and performance studies related to a tangible item, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for protecting a surgical wound from contamination and are worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the material and form of the gloves, not on any reagents, instruments, or software used for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The performance studies focus on the physical properties and safety of the gloves for their intended barrier function.
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 device does not fit that description.
N/A
Intended Use / Indications for Use
"Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating 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 (comma separated list FDA assigned to the subject device)
KGO
Device Description
"Gloves are formulated using neoprene. They are coated with nitrile coating and 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)
Test: Primary Skin Irritation, Result: Gloves are non-irritating.
Test: Guinea Pig Maximization, Result: Gloves do not display any potential for sensitization.
Test: Dimensions, Result: Gloves meet requirements of ASTM D3577.
Test: Physical Characteristics, Result: Gloves meet requirements for rubber surgical gloves per ASTM D3577.
Result: Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 Freedom from Holes
Test: Powder Residual, Result: 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 Doves. Results generated values below 2mg of residual powder per glove.
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 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).
0
CardinalHealth
NOV - 4 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS K /0 25 OO
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
| Manufacturer: | Cardinal Healthcare 222 LTD.
7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng,
Rayong, 21140, Thailand |
|-----------------------------|-------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085
| Telephone: | 847-887-2325 |
|---|---|
| ------------ | -------------- |
July 15, 2010 Date Summary Prepared:
Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Product Trade Name: Coating
Common Name: Surgeon's Gloves
Surgeon's Gloves Classification Name:
Gloves are formulated using neoprene. They are coated with nitrile Device Description: coating and are offered powder-free and sterile.
- · Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Intended Use: Coating 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.
- Sterile Synthetic Neoprene Powder-Free Surgical Gloves Predicate Devices: previously cleared under 510(k) K013302 (product code KGO);
1
K102500
| Substantial Equivalence: | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile
Coating are substantially equivalent to the predicate device
identified in this 510(k) summary. Substantial equivalence can be
established in regard to intended use, physical characteristics,
design and product features. Both gloves are made of neoprene and
are coated with Nitrile. They use similar manufacturing processes. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTM
D3577. |
Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 Freedom from Holes
Gloves meet powder level requirements for "Powder-Free" Powder Residual designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical Doves. Results generated values below 2mg of residual powder per glove.
No clinical data is required. Clinical Data:
. .
The Synthetic Neoprene Powder-Free Surgical Gloves with Nitrile Conclusion: The Dynaneet the technological characteristics of ASTM D3577 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096
NOV - 4 2010
Re: K102500
Trade/Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 20, 2010 Received: October 21, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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/CDRHOffices/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,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NoV . - 4 2010
Indications for Use
510(k) Number (if known): )