(176 days)
No
The 510(k) summary describes a physical medical device (exam gloves) and its performance characteristics based on standard testing methods. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is described as a "patient examination glove," which prevents contamination between the patient and examiner, serving a protective and barrier function, not a therapeutic one.
No
The device is an examination glove, intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description details its material, dimensions, and physical properties, and the testing performed relates to its physical performance and resistance to chemicals.
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 "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Device Description: The description details a physical barrier (gloves) with specific material and physical properties.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Testing Focus: The performance studies focus on the physical properties of the gloves, their resistance to chemicals (chemotherapy drugs), and biological compatibility with the skin. These are relevant to a barrier device, not a diagnostic one.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a protective barrier.
N/A
Intended Use / Indications for Use
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE – XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes
Product codes
LZC
Device Description
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
The HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves were tested for use with the following drug concentrations per ASTM D6978-05. All study results were acceptable.
Carmustine was retested on the subject device with breakthrough detected in 80.4 minutes at a concentration of 3.3 mg/ml. The predicate device had breakthrough detected at 30.7 minutes.
The following drugs had NO breakthrough detected up to 240 minutes: Paclitaxel, Rituximab, ThioTEPA, Vincrinstine Sulfate, Trisenox.
Conformance to the applicable sections of the following standards:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- 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
ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA.
No new clinical tests were required to support this 510(k) notification.
The performance data support the conclusion that the subject device is as safe, as effective, and performs as well as the legally marketed device that was submitted and cleared under K113423.
Key Metrics
- ASTM D6978-05: Acceptance criteria: No signs of breakthrough after 4 hours. Carmustine showed no signs of breakthrough after 80.4 minutes. Result: No breakthrough observed. Meets acceptance criteria. PASS
- ASTM D5151-06: 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 D6124-06: Residual powder on the subject device is 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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Haylard Health Gwendolyn George Regulatory Affairs, Technical Leader 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K160709 Trade/Device Name: HAYLARD* PURPLE NITRILE – XTRA* Powder Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: August 3, 2016 Received: August 4, 2016
Dear Ms. Gwendolyn George:
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
1
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michae DVRyan -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160709
Device Name
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves
Indications for Use (Describe)
HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes
| ChemoTherapy
Drug (conc.) | Break-
through
Time (mins) | ChemoTherapy
Drug (conc.) | Break-
through
Time (mins) | ChemoTherapy
Drug (conc.) | Break-
through
Time (mins) |
|------------------------------------|----------------------------------|----------------------------------|----------------------------------|-----------------------------------|----------------------------------|
| Arsenic Trioxide
(1 mg/ml) | > 240 | Doxorubicin HCI
(2 mg/ml) | > 240 | Paraplatin
(10 mg/ml) | > 240 |
| Azacitidine (Vidaza)
(25 mg/ml) | > 240 | Ellence
(2 mg/ml) | > 240 | Pemetrexed
(25 mg/ml) | > 240 |
| Bendamustine
(5 mg/ml) | > 240 | Eribulin Mesylate
(0.5 mg/ml) | > 240 | Pertuzumab
(30 mg/ml) | > 240 |
| Bleomycin sulfate
(15 mg/ml) | > 240 | Etoposid
(20 mg/ml) | > 240 | Raltitrexed
(0.5 mg/ml) | > 240 |
| Bortezomib (Velcade)
(1 mg/ml) | > 240 | Fludarabine
(25 mg/ml) | > 240 | Retrovir
(10 mg/ml) | > 240 |
| Busulfan
(6 mg/ml) | > 240 | Fulvestrant
(50 mg/ml) | > 240 | Rituximab
(10 mg/ml) | > 240 |
| Carfilzomib
(2 mg/ml) | > 240 | Fluorouracil
(50 mg/ml) | > 240 | Temsirolimus
(25 mg/ml) | > 240 |
| Carboplatin
(10 mg/ml) | > 240 | Gemcitabine
(38 mg/ml) | > 240 | ThioTEPA
(10 mg/ml) | > 240 |
| Carmustine
(3.3 mg/ml) | 80.4 | Idarubicin
(1 mg/ml) | > 240 | Topotean HCI
(1 mg/ml) | > 240 |
| Cetuximab (Erbitux)
(2 mg/ml) | > 240 | Ifosfamide
(50 mg/ml) | > 240 | Trastuzumab
(21 mg/ml) | > 240 |
| Cisplatin
(1 mg/ml) | > 240 | Irinotecan
(20 mg/ml) | > 240 | Triclosan
(1 mg/ml) | > 240 |
| Cyclophosphamide
(20 mg/ml) | > 240 | Mechlorethamine
HCl (1 mg/ml) | > 240 | Trisenox
(0.1 mg/ml) | > 240 |
| Cytarabine HCI
(100 mg/ml) | > 240 | Melphalan
(5 mg/ml) | > 240 | Vinblastine
(1 mg/ml) | > 240 |
| Cytovene
(10 mg/ml) | > 240 | Methotrexate
(25 mg/ml) | > 240 | Vincrinstine Sulfate
(1 mg/ml) | > 240 |
| Dacarbazine
(10 mg/ml) | > 240 | Mitomycin
(0.5 mg/ml) | > 240 | Vinorelbine
(10 mg/ml) | > 240 |
| Daunorubicin Hcl
(5 mg/ml) | > 240 | Mitoxantrone
(2 mg/ml) | > 240 | Zoledronic Acid
(0.8 mg/ml) | > 240 |
| Decitabine
(5 mg/ml) | > 240 | Oxaliplatin
(2mg/ml) | > 240 | | |
| Docetaxel
(10 mg/ml) | > 240 | Paclitaxel
(6 mg/ml) | > 240 | | |
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
| Date Summary
| was Prepared: | September 6, 2016 |
|---|---|
| 510(k) Submitter: | Gwendolyn George |
| Technical Leader, Regulatory Affairs | |
| Halyard Health | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Email: Gwendolyn.George@hyh.com | |
| Ph: 520-204-6442 | |
| Establishment Registration Number 3011270181 | |
| Primary Contact for | |
| this 510(k) | |
| Submission: | Gwendolyn George |
| Technical Leader, Regulatory Affairs | |
| Halyard Health | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Email: Gwendolyn.George@hyh.com | |
| Ph: 520-204-6442 | |
| Device Trade Name: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves |
| Device Common | |
| Name: | Medical Exam Gloves |
| Device Product Code | |
| and Classification | |
| Name: | LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove, Specialty | |
| Predicate Device: | K113423 |
| Kimberly-Clark PURPLE NITRILE –XTRA* Powder-Free Exam Glove tested | |
| for use with chemotherapy drugs - 12" Length | |
| Subject Device | |
| Description: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" |
| disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, | |
| non-sterile patient examination gloves that have been tested for use with | |
| chemotherapy drugs. | |
| Intended Use: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves tested for |
| use with Chemotherapy Drugs are powder-free patient examination gloves that | |
| are a disposable device intended for medical purposes worn on the examiner's | |
| hand or finger to prevent contamination between patient and examiner. This is | |
| an over the counter medical device. The HALYARD* PURPLE NITRILE – | |
| XTRA* Powder-Free Exam Gloves have been tested with the following | |
| Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine | |
| showed break through at 80.4 minutes. |
4
Halyard Health 510(k) for the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves`
| | Break-
through
Time
(mins) | ChemoTherapy
Drug (conc.) | Break-
through
Time
(mins) | ChemoTherapy
Drug (conc) | Break-
through
Time
(mins) |
|---------------------------------------|-------------------------------------|----------------------------------|-------------------------------------|--------------------------------------|-------------------------------------|
| ChemoTherapy
Drug (conc.) | | | | | |
| Arsenic Trioxide
(1 mg/ml) | > 240 | Doxorubicin HCI
(2 mg/ml) | > 240 | Paraplatin
(10 mg/ml) | > 240 |
| Azacitidine
(Vidaza) (25
mg/ml) | > 240 | Ellence
(2 mg/ml) | > 240 | Pemetrexed
(25 mg/ml) | > 240 |
| Bendamustine
(5 mg/ml) | > 240 | Eribulin Mesylate
(0.5 mg/ml) | > 240 | Pertuzumab
(30 mg/ml) | > 240 |
| Bleomycin sulfate
(15 mg/ml) | > 240 | Etoposid
(20 mg/ml) | > 240 | Raltitrexed
(0.5 mg/ml) | > 240 |
| Bortezomib
(Velcade) (1
mg/ml) | > 240 | Fludarabine
(25 mg/ml) | > 240 | Retrovir
(10 mg/ml) | > 240 |
| Busulfan
(6 mg/ml) | > 240 | Fulvestrant
(50 mg/ml) | > 240 | Rituximab
(10 mg/ml) | > 240 |
| Carfilzomib
(2 mg/ml) | > 240 | Fluorouracil
(50 mg/ml) | > 240 | Temsirolimus
(25 mg/ml) | > 240 |
| Carboplatin
(10 mg/ml) | > 240 | Gemcitabine
(38 mg/ml) | > 240 | ThioTEPA
(10 mg/ml) | > 240 |
| Carmustine
(3.3 mg/ml) | 80.4 | Idarubicin
(1 mg/ml) | > 240 | Topotean HCl
(1 mg/ml) | > 240 |
| Cetuximab
(Erbitux)
(2 mg/ml) | > 240 | Ifosfamide
(50 mg/ml) | > 240 | Trastuzumab
(21 mg/ml) | > 240 |
| Cisplatin
(1 mg/ml) | > 240 | Irinotecan
(20 mg/ml) | > 240 | Triclosan
(1 mg/ml) | > 240 |
| Cyclophosphamide
(20 mg/ml) | > 240 | Mechlorethamine
HCl (1 mg/ml) | > 240 | Trisenox
(0.1 mg/ml) | > 240 |
| Cytarabine HCI
(100 mg/ml) | > 240 | Melphalan
(5 mg/ml) | > 240 | Vinblastine
(1 mg/ml) | > 240 |
| Cytovene
(10 mg/ml) | > 240 | Methotrexate
(25 mg/ml) | > 240 | Vincrinstine
Sulfate (1
mg/ml) | > 240 |
| Dacarbazine
(10 mg/ml) | > 240 | Mitomycin
(0.5 mg/ml) | > 240 | Vinorelbine
(10 mg/ml) | > 240 |
| Daunorubicin Hcl
(5 mg/ml) | > 240 | Mitoxantrone
(2 mg/ml) | > 240 | Zoledronic
Acid
(0.8 mg/ml) | > 240 |
| Decitabine
(5 mg/ml) | > 240 | Oxaliplatin
(2mg/ml) | > 240 | | |
| Docetaxel
(10 mg/ml) | > 240 | Paclitaxel
(6 mg/ml) | > 240 | | |
(Note within 510(k) Summary only: The difference between the subject and predicate devices' indications for use do not affect substantial equivalence.)
Summary of Technologies: The technological characteristics and intended use of the subject and predicate device are substantially equivalent. The subject device is increased in thickness. This change resulted in improved Carmustine permeation time of 80.4 minutes at a 3.3 mg/ml concentration and expanded chemotherapy drug resistance claim to 23 additional drugs as reflected in the table below.
5
| F | Subject Device | Predicate Device
K113423 | Substantially
Equivalent |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| FDA Product Code | LZC | LZC | Yes |
| FDA Classification | Class 1 | Class 1 | Yes |
| Common Name | Medical Exam Glove | Medical Exam Glove | Yes |
| Device Trade Name | HALYARD* PURPLE NITRILE -
XTRA* Powder-Free Exam Gloves | Kimberly-Clark Purple Nitrile-XTRA
Powder-Free Exam Gloves - 12"
Length | Yes |
| Intended Use | HALYARD* PURPLE NITRILE -
XTRA* Powder-Free Exam Gloves
are 12" in length, a disposable
device intended for medical
purposes that is worn on the
examiner's hand and finger to
prevent contamination between
patient and examiner. | The Kimberly-Clark Purple Nitrile-
XTRA Powder-Free Exam Glove
tested for use with chemotherapy
drugs -12" Length 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. | Yes |
| Technological
Characteristics | Purple colored, chlorinated, nitrile,
powder-free, textured fingertip,
ambidextrous, non - sterile patient
examination glove. | Purple colored, chlorinated, nitrile,
powder-free, textured fingertip,
ambidextrous, non- sterile patient
examination glove. | Yes |
| Performance Data | | | |
| ASTM D6978-05
Standard Practice for
Assessment of
Resistance of Medical
Gloves to Permeation by
Chemotherapy Drugs | Acceptance criteria: No signs of
breakthrough after 4 hours.
Carmustine showed no signs of
breakthrough after 80.4 minutes
Result: No breakthrough observed.
Meets acceptance criteria. PASS | Acceptance criteria: No signs of
breakthrough after 4 hours.
Carmustine showed no signs of
breakthrough after 30.7 minutes
Result: No breakthrough observed.
Meets acceptance criteria. PASS | Yes |
| 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. The
device meets the acceptance criteria
of the standard. PASS | 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 | Yes |
| ASTM D6124-06
Standard Test Method
for Residual Powder on
Medical Gloves | Residual powder on the subject
device is within the powder-free
limit of