(107 days)
No
The 510(k) summary describes a disposable medical glove and its performance characteristics, with no mention of AI or ML technology.
No
This device is an exam glove intended to prevent contamination between the patient and examiner, not to provide therapy or treatment to a patient.
No.
The device is an exam glove used to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical medical device (exam gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of a glove.
- Performance Studies: The performance studies focus on the physical properties of the glove, such as resistance to chemotherapy drugs, holes, powder content, and physical dimensions, as well as biocompatibility (sensitization and irritation). These are not the types of performance studies typically associated with IVD devices (which would involve analytical and clinical performance related to detecting or measuring substances in biological samples).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The testing for chemotherapy drug resistance is a specific performance characteristic relevant to the intended use of preventing contamination, particularly in environments where chemotherapy drugs are handled. It does not transform the glove into an IVD.
N/A
Intended Use / Indications for Use
The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box. Device follows consensus standards:
• ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications
• ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
• ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
• ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity
• ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance testing based on consensus standards.
Key Results:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: No signs of breakthrough after 4 hours for 10 drugs. Carmustine showed no signs of breakthrough until 0.3 minutes and Thiotepa showed no signs of breakthrough until 30.9 minutes. Result: Meets acceptance criteria.
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage with an actual AQL of 1.0%.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: Residual powder on the subject device is an average of 0.04 mg/glove within the powder-free limit of
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Halyard Health Christine Macauley Regulatory Affairs Technical Leader 5405 Windward Parkway Alpharetta. Georgia 30004
Re: K180646
Trade/Device Name: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC. LZA Dated: Jun 11, 2018 Received: June 12, 2018
Dear Christine 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, Isting 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180646
Device Name
Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Halyard Lavender Nitrile Powder-Free 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. These gloves were tested for use with the following chemotherapy drugs:
- Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes Warning: Not for Use With : Carmustine, ThioTEPA
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary-K180646
| Date Summary
| was Prepared | June 26, 2018 |
|---|---|
| 510(k) Submitter | Christine L. Macauley |
| Regulatory Affairs Technical Leader | |
| Halyard Health, Inc. | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Email: Chris.Macauley@hyh.com | |
| Ph: 470-448-5158 | |
| Primary Contact for | |
| this 510(k) Submission | Same as above |
| Device Trade Name | Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with |
| Chemotherapy Drugs | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Predicate Device | K172525 |
| Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Use | |
| with Chemotherapy Drugs | |
| Reference Device | K081260 |
| Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves | |
| Subject Device Description | Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with |
| Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, | |
| powder-free, textured fingertip, ambidextrous, non-sterile patient | |
| examination gloves that are packed in a cardboard dispenser box. Device | |
| follows consensus standards: | |
| • ASTM D5151-06 Standard Test Method for Detection of Holes in | |
| Medical Gloves | |
| • ASTM D6319-10 Standard Specification for Nitrile Examination | |
| Gloves for Medical Applications | |
| • ASTM D6124-06 Standard Test Method for Residual Powder on | |
| Medical Gloves | |
| • ASTM D6978-05 Standard Practice for Assessment of Resistance of | |
| Medical Gloves to Permeation by Chemotherapy Drugs | |
| • ISO 10993-11:2006, Biological evaluation of medical devices - Part | |
| 11: Tests for Systemic Toxicity | |
| • ISO 10993-10: 2010: Biological evaluation of medical devices - Part | |
| 10: Tests for Irritation and Skin Sensitization |
4
| Indications for Use | The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with
Chemotherapy Drugs is a disposable device intended for medical purposes that
is worn on the examiner's hand to prevent contamination between patient and
examiner. These gloves were tested for use with the following chemotherapy
drugs:
• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
Warning: Not for Use With: Carmustine, ThioTEPA | | | | |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Comparison of Technological
Characteristics | Subject K180646
Lavender-colored, 9.5 inch, nitrile,
powder-free, textured fingertip,
ambidextrous, non-sterile patient
examination glove. | | Predicate K172525:
Blue-colored, 9.5 inch, nitrile, powder-
free, ambidextrous, non-sterile patient
examination glove. | | |
| Summary of comparison of
technological characteristics | There are no different technological characteristics of the subject device
compared to the predicate device. They are powder-free non-sterile nitrile exam
gloves tested for resistance to permeation by chemotherapydrugs. The
predicate device is a different color. This difference does not raise new issues of
safety or effectiveness of the subject device. | | | | |
| Comparison of the Subject Device with the Predicate Device | | | | | |
| | Subject Device | | Predicate Device K172525 | Remarks | |
| FDA Product
Code | LZC | | LZC | Same | |
| FDA
Classification | Class I | | Class I | Same | |
| Common Name | Medical Exam Glove | | Medical Exam Glove | Same | |
Blue Non-Sterile Powder Free
Nitrile Examination Gloves Tested
for Use with ChemotherapyDrugs
Device Trade
Name
Halyard Lavender Nitrile Powder-
Free Exam Gloves Tested for Use
with ChemotherapyDrugs
Similar but different
color
5
| Indications for
Use | The Halyard Lavender 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. These gloves were
tested for use with chemotherapy
drugs listed on the label. | Non-Sterile Powder Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs is
a disposable device intended for
medical purposes that is worn on
the examiner's hand to prevent
contamination between patient
and examiner. | Same |
|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Technological
Characteristics | Lavender-colored, 9.5 inch, nitrile,
powder-free, textured fingertip,
ambidextrous, non-sterile patient
examination glove. | Technological characteristics and
design meet ASTM D6319-10 and
follow the FDA's Medical Glove
Guidance Manual. | Similar |
| | | Performance Data | |
| Standard | Results
Subject Device | Results
K172525 | Remarks |
| ASTM D6978-05
Standard
Practice for
Assessment of
Resistance of
Medical Gloves
to Permeation
by
Chemotherapy
Drugs | No signs of breakthrough after 4
hours for 10 drugs.
Carmustine showed no signs of
breakthrough until 0.3 minutes and
Thiotepa showed no signs of
breakthrough until 30.9 minutes.
Result: Meets acceptance criteria.
• Cyclophosphamide (20.0 mg/ml) No
breakthrough up to 240 minutes
• Doxorubicin HCl (2.0 mg/ml) No
breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No
breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No
breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No
breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No
breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No
breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No
breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No
breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No
breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No
breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg.ml) No
breakthrough up to 30.9 minutes | Results from the Permeation data
for the predicate device.
• 5-Fluorouracil (50.0 mg/ml) No
breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No
breakthrough up to 240 minutes
• Cyclophosphamide (20.0 mg/ml)
No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No
breakthrough up to 12.4 minutes
• ThioTEPA (10.0 mg.ml) No
breakthrough up to 24.4 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No
breakthrough up to 240 minutes
• Doxorubicin HCl (2.0 mg/ml) No
breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No
breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No
breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No
breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No
breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No
breakthrough up to 240 minutes | Similar |
6
| ASTM D5151-06
Standard Test
Method for
Detection of
Holes in Medical
Gloves | Testing of the subject device
shows it meets the 2.5% AQL
requirement in the standards for
leakage with an actual AQL of
1.0%. | Testing results from the
Predicate device:
In accordance with ASTM D5151-
06, following ASTM D6319 AQL
2.5/Inspection Level G-I | Similar |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6124-06
Standard Test
Method for
Residual
Powder on
Medical Gloves | Residual powder on the subject
device is an average of 0.04
mg/glove within the powder-free
limit of