(108 days)
No
The device description and performance studies focus on the physical and material properties of surgical gloves, with no mention of AI or ML technologies.
No
The device, surgeon's gloves, is intended to protect a surgical wound from contamination, not to treat or cure a disease or condition. Its purpose is protective, not therapeutic.
No
The device is described as powder-free sterile brown color surgeon's gloves with Nitrile coating, intended to be worn by operating room personnel to protect a surgical wound from contamination. Its purpose is protective, not diagnostic.
No
The device is described as surgical gloves made of natural rubber latex with a nitrile coating, which are physical hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The provided text clearly describes a surgical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used on the body (or to protect the body from the environment), not a device used to test specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, based on the provided information, this device is a surgical glove, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural 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
Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.
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.
Test: Freedom from Holes, Result: Gloves meet requirements of 21 CFR 800.20 and ASTM D3577
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 gloves. Results generated values below 2mg of residual powder per glove.
Test: Protein Content, Result: Gloves have been tested in accordance with ASTM D5712 and yielded the results of less than 50 µg/dm² of total water extractable protein per glove
Clinical Data: No clinical data is required.
Conclusion: The Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating and Protein Content Label Claim of 50µg/dm² or less meet the technological characteristics of ASTM D3577 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K101811/5001
OCT 1 5 2010 Page of _
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
Cardinal Healthcare 222 LTD. Manufacturer: 7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand
Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085
847-887-2325 Telephone:
May 15, 2010 Date Summary Prepared:
Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating Product Trade Name: with Protein Content Label Claim of 50ug/dm- or less
- Surgeon's Gloves Common Name:
Surgeon's Gloves Classification Name:
Device Description: Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.
- These powder-free sterile brown color surgeon's gloves with Nitrile Intended Use: coating are a disposable device made of natural 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.
1
K101811/5001
| Predicate Devices: | Coated Sterile Latex Powder-Free Surgical Gloves with Protein
-Content-Label-Claim-(50-micrograms-or-less)-previously-cleared ----
under 510(k) K992171 (product code KGO); |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating
with Protein Content Label Claim of 50µg/dm² or less 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 natural rubber latex using similar
manufacturing process. |
| 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. |
| 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. |
| Protein Content | Gloves have been tested in accordance with ASTM D5712 and
yielded the results of less than 50 µg/dm² of total water extractable
protein per glove |
| Clinical Data: | No clinical data is required. |
| Conclusion: | The Sterile Latex Powder-Free Surgical Gloves with Nitrile
Coating and Protein Content Label Claim of 50µg/dm² or less meet
the technological characteristics of ASTM D3577 performance
standard and are substantially equivalent to the predicate device
identified in this 510(k) summary. |
:
2
Public Health Service
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
0CT 1 5 2010
Re: K101811
Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating With Protein Content Label Claim of 50ug/dm2 or less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 29, 2010 Received: October 1, 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,
Nh 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
K101811/5001
Indications for Use
OCT 1 5 2010
510(k) Number (if known): _
.
Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating with Protein Content Label Claim of 50 ug/dm2 or less
Indications for Use: These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural 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)
Elizabeth F. Clavius-Wilson
(Division Sign-Off)
| Division of Anesthesiology | General Hospital |
|---|---|
| Infection Control, Devices |
| 510(k) N | K101811 |
|---|---|
| ---------- | --------- |
Cardinal Health, Inc.
Premarket Notification Submission – Traditional 510(k)
4