(25 days)
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is 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.
The provided document describes a 510(k) premarket notification for "Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating." This is a medical device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a new clinical benefit through extensive clinical studies. Therefore, many of the typical elements of AI/software device studies (like MRMC studies, training set details, or complex ground truth establishment) are not applicable here.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with ASTM standards and regulatory requirements for surgical gloves. The "reported device performance" refers to the results of tests conducted to demonstrate this compliance.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Primary Skin Irritation: Non-irritating. | Primary Skin Irritation: Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization): No potential for sensitization (i.e., not a sensitizer). | Guinea Pig Maximization: Gloves do not display any potential for sensitization. | |
| Physical Properties | Dimensions: Meets requirements of ASTM D3577 (Standard Specification for Rubber Surgical Gloves). | Dimensions: Gloves meet requirements of ASTM D3577. |
| Physical Characteristics: Meets requirements for rubber surgical gloves per ASTM D3577. | Physical Characteristics: Gloves meet requirements for rubber surgical gloves per ASTM D3577. | |
| Freedom From Holes: Meets requirements of 21 CFR 800.20 and ASTM D3577 (specifying acceptable quality limits for holes). | Freedom From Holes: Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. | |
| Chemical Properties | Powder Residual: Meets powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM standard D6124 (typically < 2 mg per glove). | Powder Residual: Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577 tested using ASTM standard D6124. Results generated values below 2mg of residual powder per glove. |
| Protein Content: Meets protein content label claim of 50 µg/dm² or less, tested in accordance with ASTM D5712 (Standard Test Method for the Measurement of Water-Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method). | Protein Content: Gloves have been tested in accordance with ASTM D5712 and yielded the results of less than 50 µg/dm² of total water extractable protein per glove. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the granular sample sizes (e.g., number of gloves tested) for each specific test (e.g., how many gloves for a freedom from holes test, or how many guinea pigs for sensitization). However, it indicates that the tests met the requirements of the specified ASTM standards. These standards themselves define appropriate sampling plans and methodologies.
- Sample Size: Not explicitly given numerically, but implied to be sufficient to meet the statistical requirements of the cited ASTM standards and 21 CFR 800.20.
- Data Provenance: The tests were conducted by the applicant, Cardinal Health, Inc. Implicitly, these are prospective tests performed specifically for this 510(k) submission, likely performed at their own facilities or accredited contract labs. The country of origin of the data is the USA (applicant address in McGaw Park, IL).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of device (surgical gloves), "ground truth" is established through standardized laboratory testing and chemical analysis, not through expert clinical interpretation in the same way an AI diagnostic device would.
- Number of Experts: Not applicable in the context of clinical expert review. The "experts" are the lab technicians, chemists, and quality engineers performing and interpreting the results of the ASTM and biocompatibility tests.
- Qualifications of Experts: Not specified, but assumed to be appropriately qualified personnel trained in performing the specific ASTM and ISO (for biocompatibility) test methods.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret medical images or data. This is not applicable to the performance testing of surgical gloves. The results of the tests are based on objective measures and adherence to established protocols.
- Adjudication Method: Not applicable. Performance is determined by objective laboratory measurements against acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is used to compare the performance of human readers, often with and without AI assistance, especially in radiology and pathology. This type of study is not relevant for the regulatory clearance of surgical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an AI/algorithm device. The "device" is a physical product (surgical glove). Performance is measured directly through physical, chemical, and biological testing, not through an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance claims is based on:
- Standardized Laboratory Test Results: Objective measurements obtained through recognized and validated ASTM (American Society for Testing and Materials) methods for physical properties, powder residue, and protein content.
- Biocompatibility Test Results: Objective results from tests like Primary Skin Irritation and Guinea Pig Maximization, often following ISO standards for medical device biocompatibility.
- Regulatory Standards: Compliance with specific sections of the Code of Federal Regulations (e.g., 21 CFR 800.20 for freedom from holes).
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured using a defined process, and its performance is verified through testing samples, not by training a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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MAY - 6 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 graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH HYDROGEL COATING
| Applicant: | Cardinal Health, Inc. |
|---|---|
| Address: | 1430 Waukegan RoadMcGaw Park, IL 60085 |
| Telephone: | 847-887-2325 |
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |
| Date Summary Prepared: | February 18, 2011 |
| Product Trade Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coatingwith Protein Content Label Claim of 50 $\mu$ g/dm2 or less |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Device Description: | The proposed device is a sterile latex powder-free surgical glovethat is formulated using natural rubber latex. The glove is coatedwith hydrogel polymer coating.The glove is manufactured using molds that feature anti-slip finish,independent thumb and mechanically locking cuffs to help preventcuff roll down. They are offered powder-free and sterile. |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable device madeof natural rubber intended to be worn by operating room personnelto protect a surgical wound from contamination. |
| Predicate Devices: | Sterile Latex Powder-Free Surgical Gloves with Nitrile Coatingwith Protein Content Label Claim of 50 $\mu$ g/dm2 or less previouslycleared under 510(k) K101811 (product code KGO). |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicatedevice identified in this 510(k) summary. Substantial equivalencecan be established in regard to intended use, physical propertiesand characteristics, design and product features. Both gloves aremade of natural rubber latex using similar manufacturing process. |
| Performance Testing: | The glove characteristics are summarized below as compared toASTM requirements and to the predicate device. |
| 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 ASTMD3577. |
| 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. Results generated values below 2mg of residual powderper glove. |
| Protein Content | Gloves have been tested in accordance with ASTM D5712 andyielded the results of less than 50 µg/dm² of total water extractableprotein per glove |
| Clinical Data: | No clinical data is required. |
| Conclusion: | The Sterile Latex Powder-Free Surgical Gloves with HydrogelCoating with Protein Content Label Claim of 50µg/dm² or lessmeet the technological characteristics of ASTM D3577 StandardSpecification for Rubber Surgical Gloves and are substantiallyequivalent to the predicate device identified in this 510(k)summary. |
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Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The lines are arranged in a way that resembles a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (CONT'D)
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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K111015
Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating with Protein Content Label Claim of 50 µg/dm- or Less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: April 21, 2011 Received: April 22, 2011
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. 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.
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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 liederal 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/ucm 115809.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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
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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Indications for Use
| 510(k) Number (if known): K 015 | |
|---|---|
| Device Name: | Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating withProtein Content Label Claim of 50 µg/dm+ or less |
| Indications for Use: A powder-free sterile surgeon's glove is a disposable device made ofnatural rubber intended to be worn by operating room personnel to protecta surgical wound from contamination. |
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)
(Division Sign-Off) Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: _ K | | | O | 5
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k) ಸ್ಟ್ - ---
§ 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).