(93 days)
Not Found
No
The device is a simple latex examination glove and the summary contains no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination and is not designed to treat a disease or medical condition.
No
The device description indicates that it is a patient examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (Latex Exam Gloves) made from Natural Rubber Latex, not software. The performance studies also focus on physical properties and barrier integrity.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a physical barrier (gloves).
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical device, specifically a patient examination glove, but it falls under the category of a physical barrier device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Latex Exam Gloves are formulated using Natural Rubber Latex. The device is 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
Not Found
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 Testing:
Test: Primary Skin Irritation
Result: Gloves are non-irritating.
Test: Guinea Pig Maximization
Result: Gloves do not display any potential for sensitization.
Test: Ultimate Elongation
Result: Gloves meet requirements for latex exam rubber gloves per ASTM D 3578
Test: Tensile Strength
Result: Gloves meet requirements for latex exam rubber gloves per ASTM D 3578
Test: Barrier Defects
Result: Gloves meet requirements per 21 CFR Section 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. Cardinal Health internal AQL is 1.5
Test: Data/Test Method
Result: Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D 6124-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.
Packaging Integrity:
Packaging was tested following ANSI, AAMI, ISO 11607-1, Part 1, Packaging for terminally sterilized medical devices-Part1, and ANSI, AAMI, ISO 11607-2, Part 2, Packaging for terminally sterilized medical devices-part-2, requirements for materials, sterile barrier systems and packaging systems.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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Image /page/0/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized bird-like graphic above the words "CardinalHealth". The graphic is made up of several curved lines that suggest the wings of 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
Latex Sterile Exam Powder Free Gloves
| Regulatory Affairs Contact: | Steve Tamsett
Cardinal Health
1500 Waukegan Road
McGaw Park, IL 60085 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 578.2325 |
| Fax: | (847) 689-2715 |
| Date Summary Prepared: | 8/28/08 |
| Product Trade Name: | Sterile Latex Powder Free Exam Gloves |
| Common Name: | Exam Glove |
| Classification: | Glove, Exam LYY |
| Predicate Devices: | Cardinal Health's Powder-Free Latex Exam
Gloves (K024292) |
| Description: | Latex Exam Gloves are formulated using
Natural Rubber Latex. The device is offered
powder-free and sterile. |
Intended Use:
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
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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 brush strokes, and 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
| Substantial Equivalence: | Sterile Latex Exam Gloves are substantially
equivalent to Latex Powder-Free Exam Gloves in that
they provide the following characteristics:
- Same intended use
- Same sizes, product features
- Both made of Natural Rubber Latex using the same
manufacturing processes |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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 | Gloves meet requirements for latex exam rubber |
| gloves per ASTM D 3578 | |
| Tensile Strength | Gloves meet requirements for latex exam rubber |
| gloves per ASTM D 3578 | |
| Barrier Defects | Gloves meet requirements per 21 CFR Section |
| 800.20 AQL = 4.0 and ASTM D 3578, AQL = 2.5. | |
| Cardinal Health internal AQL is 1.5 | |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free" |
| designation using ASTM Standard D 6124-Standard test | |
| method for residual powder on medical gloves. Results | |
| generated values below 2 mg of residual powder per glove. |
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Packaging Integrity:
Packaging was tested following ANSI, AAMI, ISO 11607-1, Part 1, Packaging for terminally sterilized medical devices-Part1, and ANSI, AAMI, ISO 11607-2, Part 2, Packaging for terminally sterilized medical devices-part-2, requirements for materials, sterile barrier systems and packaging systems.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three streams flowing from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Tamsett Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K081464
Trade/Device Name: Sterile, Latex, Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 22, 2008 Received: August 26, 2008
Dear Mr. Tamsett:
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 - Mr. Tamsett
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Clive
Chin Liu, Ph.D.
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
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of three curved lines above the company name. The name "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.
Statement Indications for Use
510(k) Number: (if known): To be Assigned
Device Name: Sterile, Latex, Powder-Free Exam Gloves
Indications For Use:
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Prescription Use (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
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(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
concurrence
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081464
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