(174 days)
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No
The document describes sterile surgical gloves and their performance characteristics, with no mention of AI or ML technology.
No
The document describes surgical gloves intended to protect the surgical wound from contamination, which is a barrier function, not a therapeutic intervention on a patient's disease or condition.
No.
The device description and intended use clearly state that these are surgical gloves used for protection, not for diagnosing any medical condition.
No
The device is described as surgical gloves, which are a physical product made of synthetic rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Intended Use: The intended use of these gloves is to protect a surgical wound from contamination and to be worn by operating room personnel during medical procedures. This is a barrier function, not a diagnostic function performed on a specimen.
- Device Description: The description focuses on the material (Synthetic Rubber Latex), form (powder-free, sterile), and physical properties (elongation, tensile strength, barrier defects). These are characteristics of a physical barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: The document does not mention any analysis of biological samples, detection of analytes, or any other activity related to diagnosing a condition or providing information about a patient's health through in vitro testing.
Therefore, based on the provided information, these surgical gloves are a medical device, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Esteem Sterile Polyisoprene Surgical Gloves with Coating 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Esteem Sterile Polyisoprene Surgical Gloves with Coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
Mentions image processing
Not Found
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)
| 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 and ASTM D3577-01, AQL = 1.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-00-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.)
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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.
Esteem Sterile Polyisoprene Surgical Gloves
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.
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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
Image /page/0/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of the words "CardinalHealth" in a simple, sans-serif font. Above the text, there is a graphic element that appears to be a stylized representation of a bird in flight or a series of abstract lines.
OCT 1 5 2003
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING '
| Regulatory Affairs Contact: | Erica Sethi
Cardinal Health
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 4/7/03 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Esteem Sterile Polyisoprene Surgical Gloves |
| Description: | Esteem Sterile Polyisoprene Surgical Gloves with Coating are
formulated using Synthetic Rubber Latex. These are offered
powder-free and sterile. |
| Intended Use: | Esteem Sterile Polyisoprene Surgical Gloves with Coating 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. |
1
K031301
Page 2
| Substantial Equivalence: | Esteem Sterile Polyisoprene Surgical Gloves with Coating are
substantially equivalent to Esteem Sterile Polyisoprene Surgical
Gloves in that they provide the following characteristics:
- same intended use
- same sizes, product features, packaging
- both made of Synthetic 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 and ASTM D3577-01, AQL = 1.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free"
designation using ASTM Standard D6124-00-Standard test method
for residual powder on medical gloves. Results generated values
below 2 mg of residual powder per glove. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2003
Ms. Erica Sethi Manager, Regulatory Affairs Cardinal Heath Medical Product and Services 1500 Waukegan Road Building WM Mcgaw Park, Illinois 60085
Re: K031301
Trade/Device Name: Esteem Sterile Polyisoprene Powder Free Surgical Gloves with Coating Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 23, 2003 Received: July 24, 2003
Dear Ms. Sethi:
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.
3
Page 2 -Ms. Sethi
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 (OS) 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 vour 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 (301) 594- 4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Clis
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/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.
1500 Waukegan Road McGaw Park. Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
| Applicant: | Cardinal Health |
|---|---|
| 510(k) Number: | KO31301 |
| Device Name: | Esteem Sterile Polyisoprene Powder Free Surgical Gloves With Coating* |
| 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Or
Over-The Counter Use
Patricia D. Anderson Branch Chief, 10/15/03
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KD31301