(48 days)
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.
Esteem Ortho Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They are offered powder-free and sterile.
The provided text describes the performance testing for "Esteem Ortho Polyisoprene Powder-Free Surgical Gloves" to establish substantial equivalence to predicate devices, rather than a study proving a device meets acceptance criteria related to AI/ML performance.
Therefore, many of the requested categories are not applicable to this document. However, I can extract the relevant information from the performance testing section.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Non-irritating (implied) | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization) | No potential for sensitization (implied) | Gloves do not display any potential for sensitization. |
| Dimensions | Meet requirements of ASTM D3577 | Gloves meet requirements of ASTM D3577. |
| Ultimate Elongation & Tensile Strength | Meet requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Meet requirements of 21 CFR 800.20 and ASTM D3577 | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Meet powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM D6124 | Results generated values below 2mg of residual powder per glove. |
2. Sample size used for the test set and the data provenance: Not applicable. These are physical/material property tests on manufacturing batches, not a "test set" in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by standardized material testing procedures.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Standardized material testing methods (e.g., ASTM standards) define the "ground truth" for the physical properties of the gloves.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The "study" in this context refers to a series of performance tests conducted on the Esteem Ortho Polyisoprene Powder-Free Surgical Gloves to demonstrate their safety and effectiveness and establish substantial equivalence to predicate devices. The tests focused on physical characteristics and biocompatibility.
- Acceptance Criteria and Performance: As detailed in the table above, the acceptance criteria for various physical and biological properties are primarily based on ASTM D3577 (Standard Specification for Rubber Surgical Gloves) and 21 CFR 800.20 (dealing with freedom from holes). For each test, the gloves were found to meet these specified requirements (e.g., non-irritating, non-sensitizing, meeting dimensional and strength requirements, freedom from holes, and low powder residual).
- Clinical Data: No clinical data was required for this submission. This indicates that the safety and effectiveness were sufficiently demonstrated through the non-clinical performance testing and substantial equivalence to already cleared devices.
In conclusion, the device does meet the acceptance criteria outlined in the 510(k) submission, as demonstrated by the performance testing results, which align with established industry standards and regulatory requirements for surgical gloves.
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SEP 1 5 2009
CardinalHealth
P102
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Cardinal Healthcare 222 LTD.7/111 Moo 4, Highway 3331 Mabyangporn Pluakdaeng,Rayong, 21140, Thailand |
|---|---|
| Regulatory Affairs Contact: Tatyana Bogdan, RAC | Cardinal Health, Inc.1500 Waukegan RoadMcGaw Park, IL 60085 |
| Telephone: | 847-578-2325 |
| Date Summary Prepared: | June 12, 2009 |
| Product Trade Name: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Predicate Devices: | 1) Esteem Polyisoprene Powder-Free Surgical Gloves previouslycleared under K011721 (product code KGO);2) Ultrafree Max Sterile Latex Powder-Free Surgical Glovespreviously cleared under K010862 (product code KGO). |
| Device Description: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves areformulated using synthetic rubber latex. They are offered powder-free and sterile. |
| Intended Use: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves are adisposable device made of synthetic rubber that is intended to beworn by operating room personnel to protect a surgical woundfrom contamination in the environments within hospitals and otherhealthcare facilities. |
| Substantial Equivalence: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves aresubstantially equivalent to Esteem Polyisoprene Powder-FreeSurgical gloves in regard to intended use, sizes, design and product |
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
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K092304
p2sf2
features; they both are made of synthetic rubber latex using similar manufacturing process and packaging.
Esteem Ortho Polyisoprene Powder-Free Surgical gloves are also substantially equivalent to Ultrafree Max Sterile Latex Powder-Free Surgical gloves in regard to physical characteristics, design and product features. Both gloves are intended for use as specialty orthopedic surgeon's gloves.
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. |
| Ultimate Elongation& Tensile Strength | Gloves meet requirements for rubber surgical gloves perASTM 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 standardD6124, Standard test method for residual powder on medicalgloves. Results generated values below 2mg of residual powderper glove. |
| Clinical Data: | No clinical data was required. |
| Conclusion: | The Esteem Ortho Polyisoprene Powder-Free Surgical Glovesmeet the technological characteristics of ASTM D3577 and aresubstantially equivalent to predicate devices identified in this510(k) summary. |
Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k)
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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three parallel lines that curve upwards and to the right, with a small circle at the bottom.
SEP = 5 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring MD 20993-0002
Cardinal Healthcare, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K092304
Trade/Device Name: Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 28, 2009 Received: August 31, 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.
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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 (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.
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/CDRH Offices/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.
Anthony D. watson for
Susan Runner, D.D.S., M.A.
Acting Division 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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Indications for Use
510(k) Number (if known):
Device Name:
Esteem Ortho 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)
Shula T. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page of
510(k) Number: K092304
§ 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).