(77 days)
No
The device description and performance studies focus on the material properties and barrier performance of surgical gloves, with no mention of AI or ML.
No
The gloves are intended to protect a surgical wound from contamination, not to treat a disease or condition.
No
The device is described as surgical gloves intended to protect a surgical wound from contamination, not to diagnose a medical condition. Its function is protective and barrier-related, not diagnostic.
No
The device is a physical surgical glove made of synthetic rubber latex, not a software application.
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 barrier device used on the patient or user, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description focuses on the material and form of the gloves, consistent with a medical device used for protection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or any of the typical characteristics of an IVD.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This description does not align with that definition.
N/A
Intended Use / Indications for Use
Esteem Blue 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.
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. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Product codes
KGO
Device Description
Esteem Blue 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel in environments within hospitals and other healthcare facilities.
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)
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 & Tensile Strength; Result: Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2.
Test: Barrier Defects; Result: Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, AQL = 1.5.
Test: Data/Test Method; Result: 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.)
Not Found
Predicate Device(s)
Cardinal Health's Esteem Sterile Polyisoprene Surgical Gloves (K011721)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 a stylized graphic above the company name. The graphic is composed of several curved lines, and the text "CardinalHealth" is written in a simple, sans-serif font.
DEC - 8 2004
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
| Regulatory Affairs Contact: | Erica Sethi
Cardinal Health
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 785-3337 |
| Fax: | (847)785-2461 |
| Date Summary Prepared: | 9/13/04 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Cardinal Health's Esteem Sterile Polyisoprene Surgical
Gloves (K011721) |
| Description: | Esteem Blue Polyisoprene Surgical Gloves with coating are
formulated using Synthetic Rubber Latex. These are offered
powder-free and sterile. |
| Intended Use: | Esteem Blue 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
| Substantial Equivalence: | Esteem Blue 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 D3577-01a2. |
| Barrier Defects | Gloves exceed requirements per 21 CFR
§800.20 and ASTM D3577-01a2, AQL = 1.5. |
| 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. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2004
Cardinal Health C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548-1289
Re: K042574
Trade/Device Name: Esteem Blue Polyisoprene Surgical Glove with Coating (Containing Chitosan, ProvitaminB, Gluconolactone and Glycerol) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 24, 2004 Received: November 26, 2004
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.
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 - 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 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 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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
f Susan Tuono
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
4
Indications for Use
510(k) Number (if known): K042574
Esteem Blue Polyisoprene Surgical Glove with coating (containing Device Name: Chitosan, ProvitaminB, Gluconolactone and Glycerol). 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. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suptie Michie Cnd.
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
Page 1 of _ _ _ _ _
510(k) Number. K042574