(91 days)
Not Found
No
The device is a disposable medical glove, and the summary focuses on its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
Explanation: This device is an exam glove designed to prevent contamination, not to treat or cure a disease or condition. Its purpose is protective, not therapeutic.
No
Explanation: The device described is an exam glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical medical glove, not a software application. The summary describes the material, intended use, and performance testing of a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 used for personal protection during medical examinations or procedures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Description: The description confirms it's an "examination glove."
- Performance Studies: The performance studies focus on the physical properties of the glove (holes, powder, tensile strength, elongation) and its resistance to permeation by chemotherapy drugs. These are relevant to its function as a protective barrier, not as a diagnostic tool.
The fact that the gloves were tested for use with chemotherapy drugs indicates their suitability for handling such substances, which is a safety feature for the user and patient, not a diagnostic function.
N/A
Intended Use / Indications for Use
The Halyard Purple Nitrile Max 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 the following chemotherapy drugs:
- · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Carlzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
- Rituximab (10 mg/ml) No breakthrough up to 240 minutes
- Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
- Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
- ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes
- Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1 mg/ml) No breakthrough up to 240 minutes
- Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
- Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
- Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
- Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
- Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"examiner's hand"
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)
- ASTM D6978-05 Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
- Subject Device: No signs of breakthrough after 4 hours for 51 drugs. Carmustine showed no signs of breakthrough until 128.5 minutes. Result: Meets acceptance criteria. No breakthrough up to 240 minutes for list of 51 drugs.
- Predicate K160709: No signs of breakthrough after 4 hours for 51 drugs. Carmustine showed no signs of breakthrough until 80.4 minutes. Result: Meets acceptance criteria. No breakthrough up to 240 minutes for list of 51 drugs.
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves:
- Subject Device: 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.
- Predicate: 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.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves:
- Subject Device: Residual powder on the subject device is an average of 0.4 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2018
Owens & Minor Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K182096
Trade/Device Name: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: August 2, 2018 Received: August 3, 2018
Dear Angela Bunn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 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 by email (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) K182096
Device Name
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Halyard Purple Nitrile Max 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 the following chemotherapy drugs:
- · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Carlzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
3
| • Rituximab (10 mg/ml) | No breakthrough up to 240 minutes |
|---|---|
| • Temsirolimus (25 mg/ml) | No breakthrough up to 240 minutes |
| • Trastuzumab (21 mg/ml) | No breakthrough up to 240 minutes |
| • ThioTEPA (10 mg/ml) | No breakthrough up to 240 minutes |
| • Topotecan HCL (1 mg/ml) | No breakthrough up to 240 minutes |
| • Triclosan (2 mg/ml) | No breakthrough up to 240 minutes |
| • Trisonex (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vincrinstine Sulfate (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vinblastine (1 mg/ml) | No breakthrough up to 240 minutes |
| • Vinorelbine (10 mg/ml) | No breakthrough up to 240 minutes |
| • Zoledronic Acid (0.8 mg/ml | |
| Carmustine (3.3 mg/ml) | permeation occurred at 128.5 minutes |
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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4
K182096 510(k) Summary
| Date Summary
| was Prepared | November 1, 2018 |
|---|---|
| Submitter | Owens & Minor Halyard, Inc. |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 USA | |
| Primary Contact for | |
| this Submission | Angela L. Bunn, RAC |
| Director Regulatory Affairs | |
| Tel: 470-448-5856 | |
| Email: angela.bunn@hyh.com | |
| Device Trade Name | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with |
| Chemotherapy Drugs | |
| Device Common Name | Patient Examination Glove |
| Device Product Code | |
| and Classification Name | LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Predicate Device | K160709 |
| Halyard Purple Nitrile-Xtra Powder-Free Exam Gloves Tested for Use | |
| with Chemotherapy Drugs | |
| Subject Device Description | Halyard Purple Nitrile Max Powder-Free Exam Gloves Tested for Use |
| with Chemotherapy Drugs are disposable, purple-colored, chlorinated, | |
| nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient | |
| examination gloves that are packed in a cardboard dispenser box |
5
| Indications for Use | The Halyard Purple Nitrile Max 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:
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carlzomib (2 mg/ml) No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatin (10 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (2 mg/ml) No breakthrough up to 240 minutes Trisonex (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 128.5 minutes |
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
6
| Technological Characteristic
Comparison Table | Subject Device
Purple-colored, 16 inch, 0.24 mm
thick at palm, nitrile, powder-free,
textured fingertip, ambidextrous,
non- sterile patient examination
glove. | Predicate K160709
Purple-colored, 12 inch, 0.11 mm thick
at palm, nitrile, powder-free, textured
fingertip, ambidextrous, non- sterile
patient examination glove. | |
|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Subject Device K182096 | Predicate Device K160709 | Comparison |
| FDA Product
Code | LZC | LZC | Same |
| FDA
Classification | Class I | Class I | Same |
| Common Name | Patient Exam Glove | Patient Exam Glove | Same |
| Device Trade
Name | Halyard Purple Nitrile Max Powder-
Free Exam Gloves Tested for Use
with Chemotherapy Drugs | Halyard Purple Nitrile Xtra
Powder-Free Exam Gloves
Tested for Use with
Chemotherapy Drugs | Similar |
| Intended Use | The Halyard Purple Nitrile Max
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 in the IFU statement. | The Halyard Purple Nitrile-Xtra
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 chemotherapy
drugs listed in the IFU statement. | Same |
| Technological
Characteristics | Purple-colored, 16 inch, 0.24 mm
thick at palm, nitrile, powder-free,
textured fingertip, ambidextrous,
non- sterile patient examination
glove. | Purple-colored, 12 inch, 0.11 mm
thick at palm, nitrile, powder-free,
textured fingertip, ambidextrous,
non- sterile patient examination
glove. | Similar |
| Performance Data | | | |
| Standard | Results
Subject Device | Results
K160709 | Remarks |
| ASTM D6978-05 | No signs of breakthrough after 4 | No signs of breakthrough after 4 | Similar with different |
| | hours for 51 drugs. | hours for 51 drugs. | breakthrough times |
| Standard | Carmustine showed no signs of | Carmustine showed no signs of | for Carmustine. |
| Practice for | breakthrough until 128.5 minutes | breakthrough until 80.4 minutes | |
| Assessment of
Resistance of | Result: Meets acceptance criteria. | Result: Meets acceptance criteria. | |
| Medical Gloves | No breakthrough up to 240 | No breakthrough up to 240 | |
| to Permeation | minutes: | minutes: | |
| by | Arsenic Trioxide (1 mg/ml) | Arsenic Trioxide (1 mg/ml) | |
| Chemotherapy | Azacitidine (Vidaza) (25 mg/ml) | Azacitidine (Vidaza) (25 mg/ml) | |
| Drugs | Bendamustine (5 mg/ml) | Bendamustine (5 mg/ml) | |
| | Bortezomib (Velcade) (1 mg/ml) | Bortezomib (Velcade) (1 mg/ml) | |
| | Bleomycin sulfate (15 mg/ml) | Bleomycin sulfate (15 mg/ml) | |
| | Busulfan (6 mg/ml) | Busulfan (6 mg/ml) | |
| | Carboplatin (10 mg/ml) | Carboplatin (10 mg/ml) | |
| | Carfilzomib (2 mg/ml) | Carfilzomib (2 mg/ml) | |
| | Cetuximab (Erbitux) (2 mg/ml) | Cetuximab (Erbitux) (2 mg/ml) | |
| | Cisplatin (1 mg/ml)
Cladribine (1 mg/ml) | Cisplatin (1 mg/ml) | |
| | Cyclophosphamide (20 mg/ml) | Cyclophosphamide (20 mg/ml)
Cytarabine HCL (100 mg/ml) | |
| | Cytarabine HCL (100 mg/ml) | Cytovene (10 mg/ml) | |
| | Cytovene (10 mg/ml) | Dacarbazine (10 mg/ml) | |
| | Dacarbazine (10 mg/ml) | Daunorubicin HCL (5 mg/ml) | |
| | Daunorubicin HCL (5 mg/ml) | Decitabine (5 mg/ml) | |
| | Decitabine (5 mg/ml) | Docetaxel (10 mg/ml) | |
| | Docetaxel (10 mg/ml) | Doxorubicin HCL (2 mg/ml) | |
| | Doxorubicin HCL (2 mg/ml) | Ellence (2 mg/ml) | |
| | Ellence (2 mg/ml) | Eribulin Mesylate (0.5 mg/ml) | |
| | Etoposide (20 mg/ml) | Etoposide (20 mg/ml) | |
| | Fludarabine (25 mg/ml)
Fluorouracil (50 mg/ml) | Fludarabine (25 mg/ml) | |
| | Fulvestrant (50 mg/ml) | Fluorouracil (50 mg/ml) | |
| | Gemcitabine (38 mg/ml) | Fulvestrant (50 mg/ml)
Gemcitabine (38 mg/ml) | |
| | Idarubicin (1 mg/ml) | Idarubicin (1 mg/ml) | |
| | Ifosfamide (50 mg/ml) | Ifosfamide (50 mg/ml) | |
| | Irinotecan (20 mg/ml) | Irinotecan (20 mg/ml) | |
| | Mechlorethamine HCL (1 mg/ml) | Mechlorethamine HCL (1 mg/ml) | |
| | Melphalan (5 mg/ml) | Melphalan (5 mg/ml) | |
| | Methotrexate (25 mg/ml) | Methotrexate (25 mg/ml) | |
| | Mitomycin (0.5 mg/ml) | Mitomycin (0.5 mg/ml) | |
| | Mitoxantrone (2 mg/ml) | Mitoxantrone (2 mg/ml) | |
| | Oxaliplatin (2 mg/ml) | Oxaliplatin (2 mg/ml) | |
| | Paclitaxel (6 mg/ml) | Paclitaxel (6 mg/ml) | |
| | Paraplatin (10 mg/ml)
Pemetrexed (25 mg/ml) | Paraplatin (10 mg/ml) | |
| | Pertuzumab (30 mg/ml) | Pemetrexed (25 mg/ml)
Pertuzumab (30 mg/ml) | |
| | Raltitrexed (0.5 mg/ml) | Raltitrexed (0.5 mg/ml) | |
| | Retrovir (10 mg/ml) | Retrovir (10 mg/ml) | |
| | Rituximab (10 mg/ml) | Rituximab (10 mg/ml) | |
| | Temsirolimus (25 mg/ml) | Temsirolimus (25 mg/ml) | |
| | Trastuzumab (21 mg/ml) | Trastuzumab (21 mg/ml) | |
| | ThioTEPA (10 mg/ml) | ThioTEPA (10 mg/ml) | |
| | Topotecan HCL (1 mg/ml) | Topotecan HCL (1 mg/ml) | |
| | Triclosan (2 mg/ml) | Triclosan (1 mg/ml) | |
| | Trisonex (1 mg/ml) | Trisonex (1 mg/ml) | |
| | Vincrinstine Sulfate (1 mg/ml) | Vincrinstine Sulfate (1 mg/ml) | |
| | Vinblastine (1 mg/ml) | Vinblastine (1 mg/ml) | |
| | Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml) | Vinorelbine (10 mg/ml) | |
| | Carmustine (3.3 mg/ml) | Zoledronic Acid (0.8 mg/ml)
Carmustine (3.3 mg/ml) permeation | |
| | permeation occurred at 128.5 | occurred at 80.4 minutes | |
| | minutes | | |
| | | | |
| | | | |
| 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. | 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. | Same |
| ASTM D6124-06
Standard Test
Method for
Residual
Powder on
Medical Gloves | Residual powder on the subject
device is an average of 0.4
mg/glove within the powder-free
limit of