(9 days)
Not Found
No
The document describes standard surgical gloves and does not mention any AI or ML capabilities.
No
Explanation: The device is described as powder-free surgeon's gloves, intended to protect a surgical wound from contamination. It does not perform any therapeutic function.
No
The device is described as "surgeon's gloves" intended to protect a surgical wound from contamination, not to diagnose a medical condition.
No
The device is a physical product (surgical gloves) made of synthetic rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for protecting a surgical wound from contamination. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material and form of the gloves, not on any components or processes used for in vitro testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical properties of the gloves (irritation, sensitization, dimensions, strength, freedom from holes, powder residual), which are relevant to their barrier function and safety for the user and patient, not to diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Esteem SMT Polyisoprene Powder-Free Surgical Gloves are a disposable device that is intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Esteem SMT Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They 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 / 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: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical gloves. Results generated values below 2mg of residual powder per glove. |
| Clinical Data: | No clinical data was required. |
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
§ 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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K 093300
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Image /page/0/Picture/2 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 bold, sans-serif font, with the first letter of each word capitalized.
OCT 8 0 2009
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Cardinal Healthcare 222 LTD. |
|---|---|
| 7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, | |
| Rayong, 21140, Thailand | |
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
| Cardinal Health, Inc. | |
| 1430 Waukegan Road | |
| McGaw Park, IL 60085 | |
| Telephone: | 847-578-2325 |
| Date Summary Prepared: | October 14, 2009 |
| Product Trade Name: | Esteem SMT Polyisoprene Powder-Free Surgical Gloves |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Device Description: | Esteem SMT Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They are offered powder-free and sterile. |
| Intended Use: | Esteem SMT Polyisoprene Powder-Free Surgical Gloves are a disposable device that is intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities. |
| Predicate Devices: | Esteem Polyisoprene Powder-Free Surgical Gloves previously cleared under 510(k) K011721 (product code KGO); |
| Substantial Equivalence: | Esteem SMT Polyisoprene Powder-Free Surgical gloves are substantially equivalent to Esteem Polyisoprene Powder-Free |
·
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Surgical gloves. Substantial equivalence can be established in regard to intended use, physical characteristics, design and product features. Both gloves are made of synthetic rubber latex using similar manufacturing process and packaging.
Performance Testing:
| Test: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTM |
| D3577. | |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free" |
| designation per ASTM D3577 tested using ASTM standard | |
| D6124, Standard test method for residual powder on medical | |
| gloves. Results generated values below 2mg of residual powder | |
| per glove. | |
| Clinical Data: | No clinical data was required. |
| Conclusion: | The Esteem SMT Polyisoprene Powder-Free Surgical Gloves meet |
| the technological characteristics of ASTM D3577 and are | |
| substantially equivalent to predicate devices identified in this | |
| 510(k) summary. |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font, and the text is black. The background is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096
OCT 3 0 2009
Re: K093300
Trade/Device Name: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 19, 2009 Received: October 21, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the clectronic 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthem Orenton
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FDA CDRH DMC
OCT 21 2009
Received
Indications for Use
510(k) Number (if known): _ | 093300
| Device Name: | Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves |
|---|---|
| -------------- | ------------------------------------------------------------- |
Indications for Use:
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.
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 OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Shippy to the paris Wills
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K O 93300
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)