(149 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.
This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance Results Summary |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. (Meets requirements) |
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. (Pass) |
| Physical Characteristics: | ||
| Dimensions | ASTM D6319 | Meet requirements |
| Physical Properties | ASTM D6319 | Meet requirements |
| Freedom from Holes | 21 CFR 800.20 & ASTM D6319 | Tested in accordance with ASTM D5151 test method with acceptable results (Meets requirements) |
| Powder Residual | ASTM D6319 (≤2.0 mg/glove for Powder-Free) | Tested using ASTM D6124 test method. Results generated values < 2mg of residual powder per glove. (Meets requirements) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for freedom from holes, number of animals for biocompatibility). However, it indicates that the tests were conducted according to recognized standards like ASTM D6319, ISO 10993-10, and 21 CFR 800.20. These standards typically define appropriate sampling plans and sample sizes for their respective tests.
The data provenance is retrospective, as the tests were conducted and summarized to demonstrate that the manufactured gloves meet the pre-defined performance standards. The country of origin of the data is not specified beyond where the testing facilities are located, which is also not detailed in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This submission does not involve expert-established ground truth in the traditional sense of clinical studies. The "ground truth" for this device is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993-10, 21 CFR 800.20). These standards themselves were developed through expert consensus within their respective fields, but the submission itself does not detail the specific experts involved in the testing or analysis of the results. The determination of "meets requirements" is based on objective measurements against these standards.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements against pre-defined quantitative or qualitative criteria within the referenced standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation is a critical factor, often comparing human performance with and without AI assistance. This device is a medical glove, and its effectiveness is determined by objective physical and biocompatibility properties, not interpretive performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, the studies presented are essentially standalone performance studies. The "device" in this context is the physical glove, and its performance is evaluated against material and physical specifications documented in the referenced standards (ASTM D6319, ISO 10993-10, etc.). There is no "algorithm" or "human-in-the-loop" component to the glove's function that would require a separate evaluation. The tests measure the intrinsic properties of the glove itself.
7. Type of Ground Truth Used:
The ground truth used is based on established industry standards and regulatory requirements.
- Biocompatibility: Standards like ISO 10993-10 define acceptable levels of irritation and sensitization.
- Physical Characteristics: Standards like ASTM D6319 define acceptable dimensions, physical properties (e.g., tensile strength, elongation), freedom from holes (water leak test), and powder residual limits.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-based device that requires a training set. The "device" is a physical product, and its performance is assessed through traditional engineering and material science testing methods, not through machine learning.
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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K122696
JAN 3 1 2013
510(K) SUMMARY
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
(A510(k) summary information in accordance with the requirements of 21 CFR 807.92)
| Applicant: | Cardinal Health |
|---|---|
| 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: October 21, 2012
Trade Name: Powder-Free Nitrile Exam Gloves (Cool Blue) Common Name: Exam Gloves Classification Name: Patient Examination Gloves Classification Panel: General Hospital Regulation: 21 CFR 880.6250 Product Code(s): LZA Legally marketed device(s) to which equivalenceNitrile Comflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs previously cleared under 510(k) K103249 (product code LZA); Reason for 510(k) Submission : New device Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue. Intended Use: A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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| Summary of the technological characteristics of the device compared to the predicate device | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | ||||||||||||||||||||||
| MaterialComposition | Nitrile | Nitrile Cornflower Blue Powder-Free ExaminationGloves Tested for Use with Chemotherapy drugs(K103249) | ||||||||||||||||||||||
| Design | Powder-FreeAmbidextrousBeaded CuffNon-Sterile | Powder-FreeAmbidextrousBeaded CuffNon-Sterile | ||||||||||||||||||||||
| Color | Cool Blue | Cornflower Blue | ||||||||||||||||||||||
| Intended Use /Indications for Use | A powder-freepatient examinationglove is a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | A powder-free patient examination glove is adisposable device intended for medical purposes thatis worn on the examiner's hand or finger to preventcontamination between patient and examiner.In addition, these gloves were tested for use withchemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment ofMedical Gloves to Permeation by ChemotherapyDrugs: | ||||||||||||||||||||||
| Chemotherapy Drug andConcentration MinimumBreakthroughDetection Timein Minutes, 0.01µg/cm²/minute Carmustine (BCNU) (3.3mg/ml) 7.28 Cisplastin, (1.0mg/ml) >240 Cyclophosphamide (20mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Etoposide (Toposar) (20mg/ml) >240 5-Fluorouracil (50 mg/ml) >240 Methotrexate (25 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10 mg/ml) 2.67 The maximum testing time is 240 minutes. Pleasenote that the following drugs have extremely lowpermeation time of less than 30 minutes: Carmustine(BCNU) (3.3 mg/ml), Thiotepa (10 mg/ml) | ||||||||||||||||||||||||
| Dimensions &Physical Properties | Meets ASTM D6319 | Meets ASTM D6319 |
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Cardinal Health, Inc. :: . Premarket Notification Submission – Traditional 510(k)
2
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| Freedom fromHoles | AQL meets 21CFR800.20 & ASTMD6319 requirements | AQL meets 21CFR 800.20 & ASTM D6319requirements | |
|---|---|---|---|
| Powder Residual | Meets requirementsof ≤2.0 mg/glove forPowder-Freedesignation perASTM D6319 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D6319 | |
| 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 PigMaximization | ISO 10993-10 | Gloves do not display any potential forsensitization. | |
| PhysicalCharacteristics:Dimensions | ASTM D6319 | Meet requirements | |
| Physical Properties | ASTM D6319 | Meet requirements | |
| Freedom from Holes(Water Leak test) | 21 CFR 800.20 &ASTM D6319 | Tested in accordance with ASTM D5151 testmethod with acceptable results | |
| Powder Residual | ASTM D6319 | Tested using ASTM D6124 test method.Gloves meet powder level requirements for"Powder-Free" designation per ASTMD6319. Results generated values < 2mg ofresidual powder per glove. | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device |
| Biocompatibility:Primary Skin Irritation | ISO 10993-1 | Meets requirements | Meets requirements |
| ISO 10993-10 | Pass | Pass | |
| Guinea PigMaximization | ISO 10993-10 | Pass | Pass |
| Dimensions | ASTM D6319 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D6319 | Meets requirements | Meets requirements |
| Freedom from Holes(Water Leak Test) | 21CFR800.20,ASTM D6319 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D6319 | Meets requirements | Meets requirements |
Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k)
:
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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
The Powder-Free Nitrile Examination Gloves (Cool Blue) meet the technological characteristics of ASTM D6319 performance standard. They are as safe, as effective, and performed as well as the legally marketed device identified in this 510(k) summary except for the chemotherapy permeation claim for which the new device was not tested.
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Image /page/4/Picture/0 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 eagle or bird-like symbol with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31 2013
Cardinal Health, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062
Re: K122696
Trade/Device Name: Powder-Free Nitrile Exam Gloves (Cool Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 18, 2013 Received: January 22, 2013
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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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): KIZZ 696
Device Name:
Powder-Free Nitrile Exam_Gloves (Cool Blue)
Indications for Use: A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Ramesh C. Panguluri -S | |
|---|---|
| 2013.01.28 11:42:53 -05'00' | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K122696 |
Page of of
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.