(267 days)
Not Found
No
The 510(k) summary describes a surgical glove and its physical and performance characteristics. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The sections specifically looking for mentions of AI, DNN, or ML are marked as "Not Found".
No
Explanation: The device is a surgical glove, intended to protect surgical wounds from contamination and is not designed to treat a disease or medical condition.
No
The device is a surgical glove, which is a barrier device used for protection during surgery, not for diagnosing medical conditions. The performance studies listed are related to the physical and biocompatibility characteristics of the glove, not its diagnostic capability.
No
The device description clearly states it is a sterile latex powder-free surgical glove, which is a physical hardware device. The performance studies also focus on physical and biological properties of the glove.
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, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and physical characteristics relevant to a barrier device (irritation, sensitization, dimensions, strength, freedom from holes, powder, protein, puncture resistance). These are not diagnostic performance metrics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery.
Product codes
KGO
Device Description
The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex and is brown in color. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature an independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
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)
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence:
Biocompatibility:
- Primary Skin Irritation (ISO 10993-10): Under conditions of the study, gloves are non-irritating.
- Guinea Pig Maximization (ISO 10993-10): Under the conditions of the study, gloves do not display any potential for sensitization.
Physical Characteristics: - Dimensions (ASTM D3577): Meet requirements.
- Physical Properties (ASTM D3577): Meet requirements for rubber surgical gloves.
- Freedom from Holes (21 CFR 800.20 & ASTM D3577): Tested in accordance with ASTM D5151 with acceptable results.
- Powder Residual (ASTM D3577 tested using ASTM standard D6124): Gloves meet powder level requirements for "Powder-Free" designation. Results generated values
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Cardinal Health 200, LLC. Ms. Caroline Miceli Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K151778
Trade/Device Name: Cardinal Health 111 Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 18, 2016 Received: February 22, 2016
Dear Ms. Caroline Miceli:
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151778
Device Name
Cardinal Health TM Sterile Latex Powder-Free Orthopedic Surgical Gloves With Hydrogel Coating
Indications for Use (Describe)
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized red bird-like shape above the words "CardinalHealth" in a bold, sans-serif font. The bird shape is made up of several curved lines that suggest movement or flight.
Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778
| Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli
1500 Waukegan Road
Waukegan, IL 60085 |
| Telephone Number: | (847) 887-6864 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | March 23, 2016 |
| Product Trade Name: | Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical
Gloves with Hydrogel Coating |
| Common Name: | Orthopedic Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code: | KGO |
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Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter capitalized and the rest in lowercase.
Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778
| Predicate Devices: | K111015 – ProtexisTM Sterile Latex Powder-Free Surgical Gloves
with Hydrogel Coating |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K903987- TriflexTM Orthopedic Sterile Surgeon's Glove |
| Reason for 510(k)
Submission: | New device |
| Device Description: | The proposed device is a sterile latex powder-free surgical glove
that is formulated using natural rubber latex and is brown in color.
The glove is coated with hydrogel polymer coating. |
| | The glove is manufactured using molds that feature an independent
thumb and mechanically locking cuffs to help prevent cuff roll
down. They are offered powder-free and sterile. This glove is for
single use only. |
| | This glove is suitable for use as a specialty surgical glove intended
for orthopedic procedures or other procedures where a thicker
barrier may be desired such as trauma and reconstructive surgery. |
| Intended Use: | A surgeon's glove is a device made of natural rubber intended to be
worn by operating room personnel to protect a surgical wound
from contamination. |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate
devices identified in this 510(k) summary. Substantial equivalence
can be established in regard to intended use, physical properties
and characteristics, design and product features. All gloves are
made of natural rubber latex using similar manufacturing
processes. |
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Image /page/5/Picture/0 description: The image contains the logo for Cardinal Health. The logo features a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778
| | New Device
Cardinal Health™
Sterile Latex Powder-
Free Orthopedic
Surgical Gloves with
Hydrogel Coating
(K151778) | Predicate Device 1
Protexis™ Sterile Latex
Powder-Free Surgical
Gloves with Hydrogel
Coating (K111015) | Predicate Device 2
Triflex™ Orthopedic
Sterile Surgeon's Glove
(K903987) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Characteristic | Sterile Latex Powder-
Free Orthopedic
Surgical Gloves with
Hydrogel Coating | Sterile Latex Powder-
Free Surgical Gloves
with Hydrogel Coating | Orthopedic Sterile
Latex Powdered
Surgeon's Glove |
| Material Composition | Natural Rubber Latex | Natural Rubber Latex | Natural Rubber Latex |
| Design | Single Use
Sterile
Powder-free
Hand Specific
Independent Thumb
Beaded Cuff
Lubricated
Hydrogel Polymer
Coating | Single Use
Sterile
Powder-free
Hand Specific
Independent Thumb
Beaded Cuff
Lubricated
Hydrogel Polymer
Coating | Single Use
Sterile
Powdered
Hand Specific
Independent Thumb
Beaded Cuff |
| Label Claim | • Latex
• Single Use
• Sterile
• Powder-free
• Hydrogel Coating
• Contains less than
50 µg/dm² of total
water extractable
protein per glove
• Puncture
Resistance $≥$ 5N | • Latex
• Single Use
• Sterile
• Powder-free
• Hydrogel Coating
• Contains less than
50 µg/dm² of total
water extractable
protein per glove | • Latex
• Single Use
• Sterile
• Powdered |
| | New Device
Cardinal Health™
Sterile Latex Powder-
Free Orthopedic
Surgical Gloves with
Hydrogel Coating
(K151778) | Predicate Device 1
Protexis™ Sterile Latex
Powder-Free Surgical
Gloves with Hydrogel
Coating (K111015) | Predicate Device 2
Triflex™ Orthopedic
Sterile Surgeon's Glove
(K903987) |
| Intended Use/
Indications for Use | Orthopedic Powder-
Free Surgeon's Glove | Powder-Free Surgeon's
Glove | Orthopedic Powdered
Surgeon's Glove |
| Dimensions &
Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | AQL meets 21CFR
800.20 & ASTM
D3577 requirements | AQL meets 21CFR
800.20 & ASTM
D3577 requirements | AQL meets 21CFR
800.20 & ASTM
D3577 requirements |
| Powder Residual | Meets requirements of
≤ 2.0 mg/glove for
Powder-Free
designation per ASTM
D3577 | Meets requirements of
≤ 2.0 mg/glove for
Powder-Free
designation per ASTM
D3577 | N/A |
| Protein Contents | Contains less than 50
µg/dm² of total water
extractable protein per
glove as tested per
ASTM D5712 | Contains less than 50
µg/dm² of total water
extractable protein per
glove as tested per
ASTM D5712 | N/A |
| Puncture Resistance | Puncture
Resistance ≥ 5N
as tested per AS/NZ
4179 | N/A | N/A |
Performance Data
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Image /page/6/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized red bird-like design above the words "CardinalHealth" in black font. The bird design is made up of several curved lines that resemble feathers or wings.
Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778
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Image /page/7/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized red bird-like design above the words "CardinalHealth" in black font. The bird design is made up of several curved lines that resemble feathers or wings.
Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence Dorfo - Now Davia
| Performance Test Summarv-New Device | |||
|---|---|---|---|
| Company of the country of the finance of the finance of the finance and the first and the first and the first and |
| Characteristics | Standard/Test/FDA
Guidance | Results Summary |
|----------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | | |
| Primary Skin Irritation | ISO 10993-10 | Under conditions of the study,
gloves are non-irritating. |
| Guinea Pig
Maximization | ISO 10993-10 | Under the conditions of the
study, gloves do not display
any potential for sensitization. |
| Physical Characteristics: | | |
| Dimensions | ASTM D3577 | Meet requirements |
| Physical Properties | ASTM D3577 | Meet requirements for rubber
surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM
D3577 | Tested in accordance with
ASTM D5151 with acceptable
results |
| Powder Residual | ASTM D3577 tested using
ASTM standard D6124 | Gloves meet powder level
requirements for "Powder-
Free" designation. Results
generated values