(25 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 for protection from contamination, not for treating a disease or condition.
No
The device is a sterile surgeon's glove, intended to protect surgical wounds from contamination, not to diagnose a disease or condition.
No
The device description clearly indicates it is a physical product (a surgical glove) made of natural rubber latex, 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 physical barrier function, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The description focuses on the physical properties and materials of the glove. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies evaluate physical characteristics, freedom from holes, powder residual, and protein content. These are relevant to the glove's function as a barrier and its safety for the user and patient, not to its ability to diagnose a condition or provide information about a patient's health status.
In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical glove does not fit that definition.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of natural 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
The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating.
The glove is manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. 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
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)
The glove characteristics are summarized below as compared to ASTM requirements and to the predicate device.
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. 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
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
MAY - 6 2011
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Page 1 of 2_
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH HYDROGEL COATING
| Applicant: | Cardinal Health, Inc. |
|---|---|
| Address: | 1430 Waukegan Road |
| McGaw Park, IL 60085 | |
| Telephone: | 847-887-2325 |
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
| Date Summary Prepared: | February 18, 2011 |
| Product Trade Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating |
| with Protein Content Label Claim of 50 $\mu$ g/dm2 or less | |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Device Description: | The proposed device is a sterile latex powder-free surgical glove |
| that is formulated using natural rubber latex. The glove is coated | |
| with hydrogel polymer coating. |
The glove is manufactured using molds that feature anti-slip finish,
independent thumb and mechanically locking cuffs to help prevent
cuff roll down. They are offered powder-free and sterile. |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable device made
of natural rubber intended to be worn by operating room personnel
to protect a surgical wound from contamination. |
| Predicate Devices: | Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating
with Protein Content Label Claim of 50 $\mu$ g/dm2 or less previously
cleared under 510(k) K101811 (product code KGO). |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate
device identified in this 510(k) summary. Substantial equivalence
can be established in regard to intended use, physical properties
and characteristics, design and product features. Both gloves are
made of natural rubber latex using similar manufacturing process. |
| Performance Testing: | The glove characteristics are summarized below as compared to
ASTM requirements and to the predicate device. |
| 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. 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 Hydrogel
Coating with Protein Content Label Claim of 50µg/dm² or less
meet the technological characteristics of ASTM D3577 Standard
Specification for Rubber Surgical Gloves and are substantially
equivalent to the predicate device identified in this 510(k)
summary. |
1
Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The lines are arranged in a way that resembles a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Page 2 of 2_
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (CONT'D)
2
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K111015
Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating with Protein Content Label Claim of 50 µg/dm- or Less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: April 21, 2011 Received: April 22, 2011
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 liederal 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/ucm 115809.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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
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
Indications for Use
| 510(k) Number (if known): K 015 | |
|---|---|
| Device Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating with |
| Protein Content Label Claim of 50 µg/dm+ or less | |
| Indications for Use: A powder-free sterile surgeon's glove is a disposable device made of | |
| natural rubber intended to be worn by operating room personnel to protect | |
| a surgical wound from contamination. |
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)
(Division Sign-Off) Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: _ K | | | O | 5
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k) ಸ್ಟ್ - ---