(103 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.
The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery
The document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements for synthetic surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 requirements of AQL 1.5 | Tested in accordance with ASTM D 5151 and meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577, ≤2.0 mg/glove for "Powder-Free" designation | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the specific tests (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). It refers to meeting standards like ASTM D3577 and ISO 10993-10, which would define appropriate sample sizes within their methodologies.
Data provenance is not specified as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are conducted according to recognized international and national standards (ISO, ASTM, CFR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical glove, and its performance is evaluated against established technical and biological standards, not through expert-labeled ground truth like in diagnostic AI studies.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation involves meeting predefined technical specifications and standards rather than human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. This is not an algorithm or AI device. The tests described are for the physical and biological characteristics of a surgical glove.
7. The Type of Ground Truth Used
The "ground truth" used is defined by established regulatory standards and recognized consensus standards (e.g., ASTM D3577 for physical properties and freedom from holes, ISO 10993-10 for biocompatibility, and 21 CFR 800.20 for freedom from holes). For example, a glove either meets the specified AQL (Acceptable Quality Level) for freedom from holes or it does not. Similarly, it either causes irritation/sensitization or it does not, according to the test protocols.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI or machine learning device and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason mentioned above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
Cardinal Health, Inc. Ms. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Rd Waukegan, IL 60085
Re: K160875
Trade/Device Name: Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 9, 2016 Received: June 13, 2016
Dear Ms. Middaugh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160875
Device Name
Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image features the logo for Cardinal Health. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that converge to a point, resembling a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 1 of 5
510(k) SUMMARY
Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Megan Middaugh1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | June 9, 2016 |
| Product Trade Name: | Cardinal Health™ Sterile Polyisoprene Powder-Free OrthopedicSurgical Gloves with Hydrogel Coating |
| Common Name: | Orthopedic Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code: | KGO |
| Predicate Devices: | 1) Esteem Ortho Polyisoprene Powder-Free Surgical SterileGloves previously cleared under K092304 on September 15,20092) Sterile Latex Powder-Free Surgical Orthopedic Gloves withHydrogel Coating cleared under K151778 on March 24, 2016 |
| Reason for 510(k)Submission: | New device |
| Device Description: | The proposed device is a disposable device. It is not made withnatural rubber latex. Instead, the gloves are formulated usingpolyisoprene, which is a synthetic rubber latex, and is brown incolor. The glove is coated with hydrogel polymer coating.The gloves are manufactured using molds that feature anti-slipfinish, independent thumb and mechanically locking cuffs to helpprevent cuff roll down. They are offered powder-free and sterile.This glove is for single use only.This glove is suitable for use as a specialty surgical glove intendedfor orthopedic procedures or other procedures where a thickerbarrier may be desired such as trauma and reconstructive surgery |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable devicemade of synthetic rubber intended to be worn by operating roompersonnel to protect a surgical wound from contamination. |
| Substantial Equivalence: | Cardinal Health™ Sterile Polyisoprene Powder-Free OrthopedicSurgical Gloves with Hydrogel Coating are substantiallyequivalent to Esteem Ortho Polyisoprene Powder-Free SurgicalSterile Gloves and the Sterile Latex Powder-Free SurgicalOrthopedic Gloves with Hydrogel Coating in regards to intendeduse, sizes, physical characteristics, design and product features. Allthree gloves are intended for use as specialty orthopedic surgeon'sgloves |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like symbol above the words "CardinalHealth" in a bold, black font. The bird symbol is made up of several curved lines that resemble feathers or wings.
Page 2 of _5
510(K) SUMMARY (CONT'D)
{5}------------------------------------------------
Page 3 of _5
Table 1: Summary of Technological Characteristics
| Summary of the technological characteristics of the device compared to the predicate devices | |||
|---|---|---|---|
| Characteristic | New DeviceCardinal Health™ Sterile Polyisoprene Powder-FreeOrthopedic Surgical Gloves with Hydrogel Coating | Predicate DeviceEsteem Ortho Polyisoprene Powder-FreeSurgical Sterile Gloves(K092304) | Predicate DeviceSterile Latex Powder-Free SurgicalOrthopedic Gloves with Hydrogel Coating(K151778) |
| Material Composition | Synthetic Polyisoprene coated with Hydrogel polymer | Synthetic Polyisoprene | Natural Rubber Latex coated with Hydrogel |
| Design | Hand SpecificIndependent ThumbBeaded CuffLubricatedPolymer Coating | Hand SpecificIndependent ThumbBeaded CuffLubricated | Hand SpecificIndependent ThumbBeaded CuffLubricatedPolymer Coating |
| Intended Use /Indication for Use | Powder-Free Orthopedic Surgeon's Glove | Powder-Free Orthopedic Surgeon's Glove | Powder-Free Orthopedic Surgeon's Glove |
| Label Claims | SterilePowder-freePolyisoprene Surgical Glove with Hydrogel CoatingNot made with natural rubber latexSingle Use OnlyOrthopedicAQL 0.65 (Freedom from Holes per ASTM D5151) | SterilePowder-freeNot made with natural rubber latexFor Single Use OnlyOrthopedic | SterilePowder-freeLatex Surgical Glove with HydrogelCoatingSingle Use OnlyOrthopedicAQL 0.65 (Freedom from Holes per ASTMD5151) |
| Dimensions &Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets 21CFR 800.20 & ASTM D3577 requirementsof AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577requirements of AQL 1.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove forPowder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove forPowder-Free designation per ASTM D3577 |
| Biocompatibility(Irritation, ISO10993-0:2010;Sensitization, ISO10993-10: 2010) | Non-Irritating, under the conditions of the studyNon-sensitizing, under the conditions of the study | Non-Irritating, under the conditions of the studyNon-sensitizing, under the conditions of thestudy | Non-Irritating, under the conditions of thestudyNon-sensitizing, under the conditions of thestudy |
{6}------------------------------------------------
Table 2: Summary of Non-Clinical Tests
| PERFORMANCE DATA | ||
|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATIONOF SUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDAGuidance | Results Summary |
| Biocompatibility: | ||
| Primary SkinIrritation | ISO 10993-10 | Non-Irritating, under the conditions of the study |
| Guinea PigMaximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meet requirements for synthetic surgicalgloves |
| Freedom from Holes | 21 CFR 800.20 &ASTM D3577 | Tested in accordance with ASTM D 5151and meets 21CFR 800.20 & ASTMD3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577 testedusing ASTMstandard D6124 | Gloves meet powder level requirements for"Powder-Free" designation per ASTMD3577. Results generated values < 2mg ofresidual powder per glove. |
{7}------------------------------------------------
| Comparative Performance Information Summary | ||||
|---|---|---|---|---|
| Characteristic | Requirement | New DeviceCardinal HealthTMSterile PolyisoprenePowder-FreeOrthopedic SurgicalGloves withHydrogel Coating | Predicate DeviceEsteem OrthoPolyisoprenePowder-FreeSurgical SterileGloves (K092304) | Predicate DeviceSterile LatexPowder-FreeSurgical OrthopedicGloves withHydrogel Coating(K151778) |
| Biocompatibility: | ISO 10993-1 | Meetsrequirements | Meetsrequirements | Meetsrequirements |
| Primary SkinIrritation | ISO 10993-10 | Non-Irritating,under theconditions of thestudy | Non-Irritating,under theconditions of thestudy | Non-Irritating,under theconditions of thestudy |
| Guinea PigMaximization | ISO 10993-10 | Non-sensitizing,under theconditions of thestudy | Non-sensitizing,under theconditions of thestudy | Non-sensitizing,under theconditions of thestudy |
| Dimensions | ASTM D3577 | Meetsrequirements | Meetsrequirements | Meetsrequirements |
| PhysicalProperties | ASTM D3577 | Meetsrequirements | Meetsrequirements | Meetsrequirements |
| Freedom fromHoles | 21CFR800.20,ASTM D3577 | Meetsrequirements | Meetsrequirements | Meetsrequirements |
| Powder Residual | ASTM D3577 | Meetsrequirements | Meetsrequirements | Meetsrequirements |
Table 3: Summary of Comparative Performance
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical data is not required.
CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Non-clinical data demonstrates Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performs as well as the legally marketed devices identified in this summary.
§ 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).