(99 days)
The Halyard® Black-Orange Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable, black-colored on the grip side and orange colored on the donning side, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are chlorinated on the donning side and are packed in a cardboard dispenser box.
The document describes the testing performed for the Halyard® Black-Orange Powder-Free Nitrile Exam Glove to demonstrate its substantial equivalence to a predicate device. This is not a study about an AI-powered device, but rather a medical device (exam glove) being evaluated against established standards. Therefore, some of the requested information regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance) is not applicable.
Here's the information that can be extracted from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves | Meets the 2.5 AQL requirement in the standards for leakage. | "Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. PASS" |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications | Holes: AQL 2.5% Length: ≥230 mm Width: 85-105mm Finger thickness: ≥0.050mm Palm thickness: ≥0.050mm Unaged Tensile: ≥14 MPa Unaged Elongation: ≥500% Aged Tensile: ≥14 MPa Aged Elongation: ≥400% Powder: ≤2mg/glove | Holes: AQL 1.0% Length: 230-258 mm Width: 85-105mm Finger thickness: 0.06-0.09mm Palm thickness: 0.05-0.07mm Unaged Tensile: ≥16 MPa Unaged Elongation: ≥500% Aged Tensile: ≥15 MPa Aged Elongation: ≥450% Powder: ≤2mg/glove "The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore the device meets the acceptance criteria of the standard. PASS" |
| ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves | < 2 mg maximum powder per glove (powder-free limit). | "Residual powder on the subject device is within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free. PASS" |
| ISO 10993-10 Biological evaluation of medical devices - Tests for Irritation | No erythema/edema up to 72 hours post exposure. | "Erythema/edema was negligible. Meets acceptance criteria. PASS" |
| ISO 10993-10 Biological evaluation of medical devices - Tests for Skin Sensitization | No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection. | "Not a sensitizer under conditions of the study. Meets acceptance criteria. PASS" |
| ISO 10993-11 Biological evaluation of medical devices - Tests for Systemic Toxicity | No signs of systemic toxicity up to 72 hours post injection. | "No systemic toxicity observed. Meets acceptance criteria. PASS" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each test. Standards like ASTM and ISO often specify minimum sample sizes for material testing, but these are not enumerated in this summary.
- Data Provenance: The tests were conducted on the "subject device" (Halyard® Black-Orange Powder-Free Nitrile Exam Glove), implicitly meaning the data is prospective, generated from the manufacturing and testing of this specific product. The country of origin of the data is not specified but would typically be where the manufacturer (Halyard Health, Alpharetta, GA, USA) conducts its testing or outsources it.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/diagnostic device where expert establishment of ground truth is relevant. The "ground truth" for the performance of the exam glove is defined by the objective physical and chemical properties and biological responses measured against established medical device standards (ASTM, ISO).
4. Adjudication method for the test set
- Not Applicable. As this is not an AI/diagnostic device, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. The results are obtained through standardized laboratory testing procedures.
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. This is not an AI-powered device, so an MRMC comparative effectiveness study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI-powered device, so standalone algorithm performance is not applicable.
7. The type of ground truth used
- The "ground truth" is based on established regulatory standards and scientifically validated test methods (ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993-10, ISO 10993-11) for medical exam gloves. These standards define the acceptable physical properties, barrier integrity, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI-powered device that requires a training set or ground truth for such.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Halyard Health Ms. Christine Macauley Regulatory Affairs Technical Leader 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K153708
Trade/Device Name: Halyard® Black-Orange Powder-free Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: February 29, 2016 Received: March 1, 2016
Dear Ms. Macauley:
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 device
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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 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
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Indications for Use
510(k) Number (if known) K153708
Device Name
Halyard® Black-Orange Powder-Free Nitrile Exam Glove
Indications for Use (Describe)
The Halyard Black-Orange Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
| 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)
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Section 2 – 510(k) Summary
| Date Summarywas Prepared: | December 21, 2015Rev: 2/26/16 |
|---|---|
| 510(k) Submitter: | Christine L. MacauleyRequlatory Affairs Technical LeaderHalyard Health5405 Windward ParkwayAlpharetta, GA 30004Email: Chris.Macauley@hyh.comPh: 470-448-5158 |
| Primary Contact forthis 510(k) Submission: | Same as above |
| Device Trade Name: | Halyard® Black-Orange Powder-Free Nitrile Exam Glove |
| Device Common Name: | Medical Exam Gloves |
| Device Product Codeand Classification Name: | LZAClass I, 21 CFR §880.6250Patient Examination Glove |
| Predicate Device: | K081260Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves |
| Subject Device Description: | Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable,black-colored on the grip side and orange colored on the donning side, nitrile,powder-free, textured fingertip, ambidextrous, non-sterile patient examinationgloves that are chlorinated on the donning side and are packed in a cardboarddispenser box. |
| Intended Use: | The Halyard® Black-Orange Powder-Free Nitrile Exam Glove is a disposabledevice intended for medical purposes that is worn on the examiner's hand toprevent contamination between patient and examiner. |
| Subject Device | Predicate DeviceK081260 | SubstantiallyEquivalent | |
|---|---|---|---|
| FDA Product Code | LZA | LZA | Yes |
| FDA Classification | Class 1 | Class 1 | Yes |
| Common Name | Medical Exam Glove | Medical Exam Glove | Yes |
| Device Trade Name | Halyard Black-Orange NitrilePowder-Free Exam Glove | Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove | Yes |
| Intended Use | The Halyard Black-Orange Powder-Free Nitrile Exam Glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | The Kimberly-Clark Lavender NitrilePowder-Free Nitrile Exam Glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | Yes |
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| Subject Device | Predicate Device K081260 | SubstantiallyEquivalent | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TechnologicalCharacteristics | Black on the grip side, orange on thedonning side, nitrile, powder-free,textured fingertip, ambidextrous, non-sterile patient examination glove. | Lavender colored, nitrile, powder-free,textured fingertip, ambidextrous, non-sterile patient examination glove. | Yes | |||||||||||||||||||||||||||||||||
| Performance DataASTM D5151 Standard TestMethod for Detection ofHoles in Medical Gloves | Testing of the subject device shows itmeets the 2.5 AQL requirement in thestandards for leakage. The devicemeets the acceptance criteria of thestandard. PASS | Testing of the subject device shows itmeets the 2.5 AQL requirement in thestandards for leakage. The devicemeets the acceptance criteria of thestandard. PASS | Yes | |||||||||||||||||||||||||||||||||
| ASTM D6319 StandardSpecification for NitrileExamination Gloves forMedical Applications | Property ASTM Spec Holes AQL 2.5% AQL 1.0% Length ≥230 mm 230-258 mm Width 85-105mm 85-105mm Finger ≥0.050mm .06-.09mm Palm ≥0.050mm .05-.07mm UnagedTensile ≥14 MPa ≥16 MPa UnagedElongation ≥500% ≥500% AgedTensile ≥14 MPa ≥15 MPa AgedElongation ≥400% ≥450% Powder ≤2mg/glove ≤2mg/glove | The physical dimensions of thesubject device are within the limits ofthe standard and the physicalproperties of the subject device meetthe requirements for tensile strengthand elongation in the standard.Therefore the device meets theacceptance criteria of the standard.PASS | Yes | |||||||||||||||||||||||||||||||||
| ASTM D6124 Standard TestMethod for Residual Powderon Medical Gloves | PASSResidual powder on the subjectdevice is within the powder-free limitof < 2 mg maximum powder per gloveand meets the acceptance criteria forpowder-free. PASS | Residual powder on the subjectdevice is within the powder-free limitof < 2 mg maximum powder per gloveand meets the acceptance criteria forpowder-free. PASS | Yes | |||||||||||||||||||||||||||||||||
| ISO 10993-10 Biologicalevaluation of medicaldevices -Tests for Irritation | Acceptance criteria: No erythema/edema up to 72 hours post exposure.Result: Erythema/edema wasnegligible. Meets acceptance criteria.PASS | Acceptance criteria: No erythema/edema up to 72 hours post exposure.Result: Erythema/edema wasnegligible. Meets acceptance criteria.PASS | Yes | |||||||||||||||||||||||||||||||||
| ISO 10993-10 Biologicalevaluation of medicaldevices -Tests for SkinSensitization | Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at24 and 48 hours post injection.Result: Not a sensitizer underconditions of the study. Meetsacceptance criteria. PASS | Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at24 and 48 hours post injection.Result: Not a sensitizer underconditions of the study. Meetsacceptance criteria. PASS | Yes |
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Halyard Health 510(k) for the Halyard Black-Orange Powder-Free Nitrile Exam Glove
| ISO 10993 Biologicalevaluation of medicaldevices - Tests forSystemic Toxicity | Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection.Result: No systemic toxicityobserved.Meets acceptance criteria. PASS | Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection.Result: No systemic toxicityobserved.Meets acceptance criteria. PASS | Yes |
|---|---|---|---|
| Conclusion | The performance data support the conclusion that the subject device is as safe, as effective, andperforms as well as the legally marketed device that was submitted and cleared under K081260. |
| Technological Characteristicsand Substantial Equivalence: | The Halyard® Black-Orange Powder-Free Nitrile Exam Glove issubstantially equivalent to the predicate device, Kimberly-ClarkLavender Nitrile Powder-Free Exam Gloves (K081260). The onlydifference is the use of different colorants that have been testedfor biocompatibility and a two-layer nitrile dipping process thatenables each of the two glove surfaces (donning surface and gripsurface) to have a different color. These new colorants andadditional nitrile layer raise no new issues of safety and efficacyas demonstrated by testing of biocompatibility and technicalproduct performance as described in this 510(k) submission. |
|---|---|
| Summary of Testing: | These gloves have been tested for conformance to the applicablesections of the following standards: |
| ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves | |
| ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Applications | |
| ASTM D6124-06 Standard Test Method for Residual Powder onMedical Gloves | |
| ISO 10993-10 Biological evaluation of medical devices -Tests forIrritation and Skin Sensitization | |
| ISO 10993-11 Biological evaluation of medical devices - Tests forSystemic Toxicity | |
| ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA. | |
| Brief Description of ClinicalTests: | No new clinical tests were required to support this 510(k)notification. |
| CONCLUSION: | The performance data support the conclusion that the subjectdevice is as safe, as effective, and performs as well as the legallymarketed device that was submitted and cleared underK081260. |
§ 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.