(106 days)
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No
The 510(k) summary describes standard latex surgical gloves and their performance characteristics related to material properties and barrier function. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device, surgical gloves, is intended to protect healthcare personnel and prevent contamination of surgical wounds, not to treat a disease or condition in a patient.
No
The device, "Latex Surgical Gloves," is intended for protection during medical procedures, not for diagnosing conditions or diseases.
No
The device is described as "Latex Surgical Gloves" and the description focuses on the physical properties and performance of the gloves, such as material, sterility, protein content, and barrier defects. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these gloves are for protecting a surgical wound from contamination and are worn by operating room personnel during medical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (Natural Rubber Latex), sterility, and protein content. These are characteristics of a physical barrier device, not a diagnostic one.
- 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 physical properties like irritation, sensitization, tensile strength, barrier defects, and powder levels. These are relevant to the function of a protective glove, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Latex Surgical Gloves are formulated using Natural Rubber Latex. These are offered powder-free and sterile. Protein Labeling Claim of 50 mcg or less of total water extractable protein
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
hospitals and other healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Primary Skin Irritation: Gloves are non-irritating.
Guinea Pig Maximization: Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength: Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01.
Barrier Defects: Gloves exceed requirements per 21 CFR §800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5. Gloves meet AQL of 1.0
Data/Test Method: Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ultimate Elongation & Tensile Strength: exceed requirements per ASTM D3577-01.
Barrier Defects: exceed requirements per 21 CFR §800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5. Gloves meet AQL of 1.0.
Data/Test Method: results generated values below 2 mg of residual powder per glove.
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).
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§ 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
Image /page/0/Picture/0 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, and the company name is written in a bold, sans-serif font.
SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)
JUN 2 2 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POLYMER COATED STERILE POWDER-FREE LATEX SURGICAL GLOVES
| Regulatory Affairs Contact: | Amy Hoyd
Cardinal Health
1500 Waukegan Road
McGaw Park, IL 60085 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 578.2325 or 612.998.9341 |
| Fax: | (847) 689.2715 |
| Date Summary Prepared: | 2/28/07 |
| Product Trade Name: | Triflex Select |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Device: | Cardinal Health's Coated Sterile Latex Powder-Free
Surgical Gloves (K992171) |
| Description: | Latex Surgical Gloves are formulated using Natural
Rubber Latex. These are offered powder-free and
sterile. Protein Labeling Claim of 50 mcg or less of
total water extractable protein |
| Intended Use: | Latex Surgical Gloves are intended for use in
environments within hospitals and other healthcare
facilities. The gloves are appropriate for use during
invasive and non-invasive medical procedures
requiring sterility. They are intended to be worn by
operating room personnel to protect a surqical wound
from contamination. |
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Image /page/1/Picture/0 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.
SUMMARY OF SAFETY AND EFFECTIVENESS As required by §807.92(c)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POLYMER COATED STERILE POWDER-FREE LATEX SURGICAL GLOVES continued
| Substantial Equivalence: | Polymer Coated Sterile Powder-Free Latex Surgical Gloves
are substantially equivalent to Coated Sterile Latex Powder-
Free Surgical Gloves in that they provide the following
characteristics: |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - same intended use |
-
same sizes, product features
-
both made of Natural Rubber Latex using similar manufacturing process
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Ultimate Elongation | |
| & Tensile Strength | Gloves exceed requirements for rubber surgical gloves |
| per ASTM D3577-01. | |
| Barrier Defects | Gloves exceed requirements per 21 CFR |
| §800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5. | |
| Gloves meet AQL of 1.0 | |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free" |
| designation using ASTM Standard D6124-01-Standard test | |
| method for residual powder on medical gloves. Results | |
| generated values below 2 mg of residual powder per glove. |
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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 depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2007
Cardinal Health, Incorporated C/O Ms. Maryalice Smith Director of Regulatory Affairs and Quality Operations Medical Products Manufacturing 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K070647
Trade/Device Name: Sterile, Latex, Powder-Free Surgeons Glove with Protein Labeling Claim of 50mcg or Less of Total Water Extractable Protein
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 24, 2007 Received: May 25, 2007
Dear Ms. Hoyd:
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 such 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.
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Page 2 - Ms. Hoyd
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Statement of Indications for Use
510(k) Number: (if known):
Device Name: Sterile, Latex, Powder-Free Surgeons Glove with Protein Labeling Claim of 50 mcg or less of total water extractable protein
Indications For Use:
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila Page 1 of Murphy, 6
n Sign-Off) rsion of Anesthesiology, General Hospital, clion Control, Dental Devices
3(K) Number: N 0767