(82 days)
This powder-free 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 intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
This document describes the regulatory submission for Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera® Coating (hereinafter referred to as "the device"). The submission is a 510(k) premarket notification, indicating that the device is a modification of a currently marketed device (Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating, cleared under 510(k) K042574).
The document is a summary of safety and effectiveness, focusing heavily on comparative performance data with a predicate device rather than a comprehensive new device study. Therefore, many of the typical elements of an AI/ML device acceptance criteria and study are not applicable in this context.
Here's an analysis based on the provided text, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (surgical gloves), the "acceptance criteria" are based on meeting established industry standards (ASTM and ISO) and regulatory requirements (21 CFR). The "performance" is demonstrated by showing that the new device meets these standards and is comparable to the predicate device.
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. |
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. |
| Physical Characteristics | ||
| Dimensions | ASTM D3577 | Meet requirements |
| Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 (Tested in accordance with ASTM D5151) | Tested in accordance with ASTM D5151 with acceptable results (AQL meets 21CFR 800.20 & ASTM D3577 requirements). |
| Powder Residual | ASTM D3577 (≤2.0 mg/glove for "Powder-Free" designation, tested using ASTM D6124) | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. |
Comparative Performance Summary (New Device vs. Predicate Device)
| Characteristic | Requirement (Standard) | New Device | Predicate Device |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | Meets requirements | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Pass | Pass |
| Guinea Pig Maximization | ISO 10993-10 | Pass | Pass |
| Physical Characteristics | |||
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20, ASTM D3577 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements |
2. Sample Sized Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom from Holes). However, it implies that standard methodologies prescribed by ASTM and ISO were followed for each test, which would inherently include appropriate sample size requirements for those standards.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed on the manufactured gloves. There is no information regarding the country of origin of the data beyond the applicant's location (McGaw Park, IL, USA). The data is generated prospectively as part of the manufacturing and quality control process for the device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable to this type of device. The "ground truth" for surgical gloves is established by objective engineering and material science standards (e.g., tensile strength, tear resistance, barrier integrity, biocompatibility as per ISO/ASTM standards), not by human expert opinion or interpretation like in an AI/ML diagnostic device.
4. Adjudication Method for the Test Set
This is not applicable. As the tests are objective, physical, and chemical measurements against defined standards, there is no need for expert adjudication.
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
This is not applicable. This submission is for a physical medical device (surgical gloves), not an AI/ML diagnostic or assistive device for human readers. There are no "human readers" in the context of this device's function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or AI component in this device. Performance is assessed through physical, chemical, and biological testing of the material and finished product.
7. The Type of Ground Truth Used
The "ground truth" (or basis for compliance) for this device is based on:
- Industry Standards: Compliance with established ASTM (American Society for Testing and Materials) standards (e.g., D3577 for rubber surgical gloves, D6124 for residual powder) and ISO (International Organization for Standardization) standards (e.g., 10993-1, 10993-10 for biocompatibility).
- Regulatory Requirements: Meeting specifications outlined in 21 CFR (e.g., 800.20 for Freedom from Holes).
These standards define the acceptable physical properties, chemical composition, and biological safety for surgical gloves.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This is not applicable. There is no "training set" or need for establishing a ground truth for it.
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SEP 2 1 2011
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 word in red and the second word in black.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA® COATING
(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)
Cardinal Health Applicant: 1430 Waukegan Road McGaw Park, IL 60085
Establishment Registration
| Number: | 1423537 |
|---|---|
| Regulatory Affairs | |
| Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
Summary Prepared: June 14, 2011
| Trade Name: | Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Coating |
|---|---|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code(s): | KGO |
| Legally marketed device(s) to which equivalence is claimed: | Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating (containing Chitosan, Provitamin B5, Gluconolactone and Glycerol) cleared under 510(k) K042574 (product code KGO) |
| Reason for 510(k) Submission: | Modification of a legally marketed device |
Device Description: The proposed device is a disposable device intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and
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Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
Intended Use:
This powder-free 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.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Modified Device | Original (Predicate) |
| MaterialComposition | Synthetic Rubber Latex -Polyisoprene | Synthetic Rubber Latex -Polyisoprene |
| Sterile Polyisoprene Powder-FreeBlue Surgical Gloves with Neu-Thera Coating | Esteem Blue Sterile PolyisoprenePowder-Free Surgical Glove withNeu-Thera Coating (K042574) | |
| Design | Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated | Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated |
| CoatingContents | Provitamin B, Gluconolactone, D-Sorbitol and Glycerol | Chitosan, Provitamin B,Gluconolactone, D-Sorbitol andGlycerol |
| Intended Use/Indications forUse | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove |
| Dimensions &PhysicalProperties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom fromHoles | AQL meets 21CFR 800.20 & ASTMD3577 requirements | AQL meets 21CFR 800.20 & ASTMD3577 requirements |
| Powder Residual | Meets requirements of ≤2.0mg/glove for Powder-Freedesignation per ASTM D3577 | Meets requirements of ≤2.0 mg/glovefor Powder-Free designation perASTM D3577 |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*
Performance Test Summary-New Device
| Characteristic | Standard/Test/FDAGuidance | Results Summary | |
|---|---|---|---|
| Biocompatibility:Primary Skin IrritationGuinea PigMaximization | ISO 10993-10ISO 10993-10 | Gloves are non-irritating.Gloves do not display any potential forsensitization. | |
| PhysicalCharacteristics: | |||
| DimensionsPhysical PropertiesFreedom from HolesPowder Residual | ASTM D3577ASTM D357721 CFR 800.20 &ASTM D3577ASTM D3577 testedusing ASTM standardD6124 | Meet requirementsMeet requirements for rubber surgical glovesTested in accordance with ASTM D5151with acceptable resultsGloves meet powder level requirements for"Powder-Free" designation per ASTMD3577. Results generated values < 2mg ofresidual powder per glove. | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device |
| Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Pass | Pass |
| Guinea PigMaximization | ISO 10993-10 | Pass | Pass |
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20,ASTM D3577 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements |
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 AND CLINICAL DATA
Non-clinical data demonstrates that Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Coating meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tatyana Bogdan Regulatory Affairs Manager Cardinal Health-Medical Products and Services 1430 Waukegan Road McGaw Park, Illinois 60085
المتحدة المنتخب المنتجات المتحدة المنتخب المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنت
Re: KI11868
Trade/Device Name: Esteem® Blue with Neu-Thera® Regulation Number: 21 CFR 878,4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: July 26, 2011 Received: July 27, 2011
Dear Ms. Bogdan:
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, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Bogdan
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Contrition, Vi, and
Anthony D. Watson, B.S., M.S., M.B.A. 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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Prescription Use
( F (Part 21 CFR 801 Subpart D)
Indications for Use
510(k) Number (if known): K111868
Esteem® Blue with Neu-Thera® Device Name:
Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Device description: Coating (containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B)
Indications for Use: This powder-free 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.
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)
(Division Sign-Off)
§ 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).