(90 days)
This powder-free 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 disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). 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.
The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 (Pass) | Gloves are non-irritating. (Meets requirements) |
| Guinea Pig Maximization | ISO 10993-10 (Pass) | Gloves do not display any potential for sensitization. (Meets requirements) |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 requirements | Meet requirements. (Meets requirements for rubber surgical gloves) |
| Physical Properties | ASTM D3577 requirements | Meet requirements for rubber surgical gloves. (Meets requirements) |
| Freedom from Holes | AQL meets 21CFR 800.20 & ASTM D3577 requirements | Tested in accordance with ASTM D5151 with acceptable results. (Meets requirements) |
| Powder Residual | ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. (Meets requirements) |
| Protein Content | < 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712 | Gloves yielded the results of less than 50 µg/dm² of total water extractable protein per glove. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of typical AI/software device studies. Instead, it refers to performance testing of the physical glove. The sample sizes for each specific test (e.g., biocompatibility, physical properties, freedom from holes) are not explicitly stated in this summary. It only indicates that tests were performed "in accordance with" the specified ASTM and ISO standards, which would imply a defined sample size for each test within those standards.
The data provenance is from non-clinical tests performed by Cardinal Health (the applicant). There is no mention of country of origin for the data, but the company is based in McGaw Park, IL, USA. The studies are prospective in the sense that they are conducted to demonstrate the properties of the manufactured glove for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance characteristics (dimensions, hole-free, protein content, etc.) is established by adherence to standardized measurement protocols defined by ASTM and ISO, rather than expert consensus. For biocompatibility, the "ground truth" on irritation and sensitization is determined by the results of standardized animal tests as per ISO 10993-10. There are no human experts involved in establishing a "ground truth" in the way one would for a diagnostic AI study.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically used in clinical studies or expert-based evaluation of medical images or diagnoses, not for the physical and biological testing of a surgical glove as described here. The results are objective measurements against defined standards.
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
No, an MRMC comparative effectiveness study was not done. This device is a surgical glove, not an AI or diagnostic tool that assists human "readers" or practitioners in interpreting information.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on standardized test methods and predetermined criteria outlined in the referenced ASTM and ISO standards, and FDA regulations (21 CFR 800.20):
- Physical Characteristics: Measured values (e.g., dimensions, force at break, elongation, powder residual, protein content) are compared against the numerical thresholds and ranges specified in ASTM D3577, ASTM D6124, ASTM D5712, and 21 CFR 800.20.
- Biocompatibility: The observed biological responses (skin irritation, sensitization potential) in animal models are evaluated against the criteria for "non-irritating" and "no potential for sensitization" as established by ISO 10993-10.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning, therefore, there is no "training set." The glove's manufacturing process is established and validated, not "trained."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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SEP 2 9 2011
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is made up of several curved lines that converge and overlap. The text "CardinalHealth" is written in a bold, sans-serif font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS For STERILE LATEX WITH NITRILE COATING 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)
| Applicant: | Cardinal Health |
|---|---|
| 1430 Waukegan Road | |
| McGaw Park, IL 60085 | |
| Establishment Registration |
| 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 Protexis™ Latex Blue with Neu-Thera® Surgical Gloves Trade Name: Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves Classification Panel: General and Plastic Surgery 21 CFR 878.4460 Regulation: Product Code(s): KGO Legally marketed device(s) to which equivalence Protegrity® Blue Sterile Powder-Free Latex/Nitrile Surgical Gloves with Neu-Thera Coating and with Protein Content Label Claim of 50 is claimed: micrograms or less (510(k) K053272, product code KGO) Reason for 510(k) Modification of a legally marketed device Submission:
Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). 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.
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Intended Use:
This powder-free 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.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Modified Device | Original (Predicate) |
| Characteristic | Sterile Latex with Nitrile CoatingPowder-Free Blue Surgical Gloveswith Neu-Thera Coating | Protegrity Blue Sterile Latex/NitrilePowder-Free Surgical Glove withNeu-Thera Coating (K053272) |
| MaterialComposition | Natural Rubber Latex coated withNitrile | Natural Rubber Latex coated withNitrile |
| 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 for Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove |
| Dimensions &Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom fromHoles | AQL meets 21CFR 800.20 &ASTM D3577 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 |
| Protein Contents | Contains less than 50 $ \mu g/dm^2 $ oftotal water extractable protein perglove as tested per ASTM D5712 | Contains less than 50 $ \mu g/dm^2 $ of totalwater extractable protein per glove astested per ASTM D5712 |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE* | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDAGuidance | Results Summary |
| Biocompatibility:Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. |
| Guinea Pig | ISO 10993-10 | Gloves do not display any potential for |
Cardinal Health, Inc. Premarket Notification Submission – Special 510(k)
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K/11878
| Maximization | sensitization. | |||
|---|---|---|---|---|
| PhysicalCharacteristics: | ||||
| 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 D5151with acceptable results | ||
| Powder Residual | ASTM D3577 testedusing ASTM standard D6124 | Gloves meet powder level requirements for"Powder-Free" designation per ASTMD3577. Results generated values < 2mg ofresidual powder per glove. | ||
| Protein Content | ASTM D5712, FDAMedical GloveGuidance Manual | Gloves yielded the results of less than 50µg/dm² of total water extractable protein perglove | ||
| 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 | |
| Protein Content | ASTM D5712 | Pass | Pass | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL 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 Latex with Nitrile Coating Powder-Free Blue Surgical | ||||
| Gloves with Neu-Thera Coating and with Protein Content Label Claim (50 micrograms or less) | ||||
| meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and |
meet the technological characteristics of ASTM D3577 standard, and are as sa
performed as well as the legally marketed devices identified in this summary.
.
.
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Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The graphic consists of three parallel, angled lines that resemble a bird in flight. The text around the border is small and difficult to read, but appears to be in a circular arrangement. The logo is black and white and has a slightly grainy texture.
Food and Drug Administration 10963 New Hampshire Avenue Document Control Room -WO(66-(160) Silver Spring, MD 20993-0002
Tatyana Bogdan Regulatory Affairs Manager Cardinal Health, Incorporated 1430 Waukegan Road Megaw Park, Illinois 60085
SEP 2 9 2011
Re: K111878
Trade/Device Name: Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating with Protein Content Labeling Claim of 50 Micrograms, or less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: 1 Product Code: KGO Dated: August 02, 2011 Received: August 8, 2011
Dear Ms. Boudan:
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 provice 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 grement 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 lightlity 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 affective 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- 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/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 10 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 Biometries/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 vours.
Th for
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): ___K111878
Protexis 110 Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating Device Name: with Protein Content Labeling Claim of 50 micrograms, or less
Sterile Latex with Nitrile Coating Powder-Free Blue Surgical Gloves with Device description: Neu-Thera Coating (containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B) and with Protein Content Labeling Claim 50 micrograms, or less.
Indications for Use: This powder-free 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.
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Edith A. Laurie-Wills
111878
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1 of _
510(k) Number:
§ 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).