(84 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.
The device is a medical glove intended to prevent contamination between patient and examiner, and to protect the examiner from certain chemotherapy drugs. It does not perform any therapeutic function on the patient or user.
No
This device is described as a disposable exam glove intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device described is a physical medical device (exam gloves) and does not involve any software component.
Based on the provided information, the Halyard Pink Underguard Nittile Powder-Free Exam Glove is not an In Vitro Diagnostic (IVD) device.
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 used for personal protection and infection control during medical examinations.
- IVD Definition: An IVD device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of the Halyard glove does not mention any function related to testing samples or providing diagnostic information. Its purpose is purely protective.
- Performance Studies: The performance studies listed focus on the physical properties of the glove (leakage, tensile strength, elongation, powder) and its resistance to chemotherapy drugs. These are relevant to its function as a barrier device, not a diagnostic one.
Therefore, the Halyard Pink Underguard Nittile Powder-Free Exam Glove falls under the category of a medical device used for personal protection and infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Halyard Pink Underguard 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:
- · 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
- Car-filzomib (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
- · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1.0 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
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
- · ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-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
Not Found
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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Subject Device (K183132): No signs of breakthrough after 4 hours for 50 drugs. Result: Meets acceptance criteria.
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
Subject Device (K183132): Testing shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications
Subject Device (K183132): The physical dimensions are within the limits of the standard and the physical properties meet the requirements for tensile strength with an average before aging of 37.89 MPa and after aging of 39.32 MPa and elongation of 602% before aging and 558% after aging.
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
Subject Device (K183132): Residual powder 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 logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 5, 2019
0 & M Halyard, Inc. Angela Bunn Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K183132
Trade/Device Name: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 8, 2018 Received: November 13, 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 mav, 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 avare 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.
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
1
requirements, including, but not limited to: registration and listing (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 (OS) 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) K183132
Device Name
Halyard Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Halyard Pink Underguard Nittile 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:
- · 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
- Car-filzomib (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
- · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1.0 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
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
- · ThioTEPA (10 mg/ml) No breakthrough up to 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
510(k) Summary (K183132)
| Date Summary was
Prepared | January 31,2019 |
---|---|
510(k) Submitter | Angela L. Bunn, RAC |
Director Regulatory Affairs | |
Tel: 470-448-5856 | |
Email: angela.bunn@hyh.com | |
Primary Contact for this | |
510(k) Submission | Same as above |
Device Trade Name | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with |
Chemotherapy Drugs | |
Device Common Name | Non-Powdered Patient Examination Glove |
Device Product Code and | |
Classification Name | LZA, LZC |
Class I, 21 CFR §880.6250 | |
Patient Examination Glove | |
Predicate Device | K081089 |
Halyard Sterling Nitrile-Xtra Powder-Free Exam Gloves Tested for Use with | |
Chemotherapy Drugs | |
Subject Device Description | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use |
with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, | |
powder-free, textured fingertip, ambidextrous, non- sterile patient examination | |
gloves that are packed in a cardboard dispenser box. | |
Indications for Use | The Halyard® Pink Underguard 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: | |
● 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 |
5
| Carfilzomib (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 mq/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
●
ldarubicin (1 mq/ml) No breakthrough up to 240 minutes
lfosfamide (50 mq/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 mq/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
Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
●
Triclosan (2 mg/ml) No breakthrough up to 240 minutes
Trisonex (1.0 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) No breakthrough up to 54.7 minutes |
ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes |
Technological Characteristic Comparison Table | |||
---|---|---|---|
Subject Device: | |||
K183132 | Predicate Device: | ||
K081089 | Comparison | ||
FDA Product | |||
Code | LZA, LZC | LZC | Same |
FDA | |||
Classification | Class I | Class I | Same |
Common Name | Non-Powdered | ||
Patient Examination Glove | Non-Powdered | ||
Patient Examination Glove | Same |
6
| Device Trade
Name | Halyard Pink Underguard Nitrile
Powder-Free Exam Gloves
Tested for Use with
Chemotherapy Drugs | Halyard Sterling Nitrile Xtra
Powder-Free Exam Gloves
Tested for Use with
Chemotherapy Drugs | Similar |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for
Use | The Halyard Pink Underguard
Nitrile 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. | The Halyard Sterling 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 on the label. | Same |
| Technological
Characteristics | Pink-colored, 12-inch, 0.09
mm thick at palm, nitrile,
powder-free, textured
fingertip, ambidextrous, non-
sterile patient examination
glove. | Gray-colored, 12-inch, 0.90 mm
thick at palm, nitrile, powder-free,
textured fingertip, ambidextrous,
non- sterile patient examination
glove. | Similar |
7
Technological Charateristic Comparison Table | |||
---|---|---|---|
Standard | Subject Device: | ||
K183132 | Predicate Device: | ||
K081089 | Comparison | ||
TM D6978-05 | |||
Standard Practice for | |||
Assessment of | |||
Resistance of | |||
Medical Gloves to | |||
Permeation by | |||
Chemotherapy Drugs | No signs of breakthrough after 4 hours for 50 | ||
drugs. | |||
Result: Meets acceptance criteria. | |||
No breakthrough up to 240 minutes: | |||
Arsenic Trioxide (1 mg/ml) | |||
Azacitidine (Vidaza) (25 mg/ml) | |||
Bendamustine (5 mg/ml) | |||
Bortezomib (Velcade) (1 mg/ml) | |||
Bleomycin sulfate (15 mg/ml) | |||
Busulfan (6 mg/ml) | |||
Carboplatin (10 mg/ml) | |||
Carfilzomib (2 mg/ml) | |||
Cetuximab (Erbitux) (2 mg/ml) | |||
Cisplatin (1 mg/ml) | |||
Cladribine (1 mg/ml) | |||
Cyclophosphamide (20 mg/ml) | |||
Cytarabine HCL (100 mg/ml) | |||
Cytovene (10 mg/ml) | |||
Dacarbazine (10 mg/ml) | |||
Daunorubicin HCL (5 mg/ml) | |||
Decitabine (5 mg/ml) | |||
Docetaxel (10 mg/ml) | |||
Doxorubicin HCL (2 mg/ml) | |||
Ellence (2 mg/ml) | |||
Etoposide (20 mg/ml) | |||
Fludarabine (25 mg/ml) | |||
Fluorouracil (50 mg/ml) | |||
Fulvestrant (50 mg/ml) | |||
Gemcitabine (38 mg/ml) | |||
Idarubicin (1 mg/ml) | |||
Ifosfamide (50 mg/ml) | |||
Irinotecan (20 mg/ml) | |||
Mechlorethamine HCL (1 mg/ml) | |||
Melphalan (5 mg/ml) | |||
Methotrexate (25 mg/ml) | |||
Mitomycin (0.5 mg/ml) | |||
Mitoxantrone (2 mg/ml) | |||
Oxaliplatin (2 mg/ml) | |||
Paclitaxel (6 mg/ml) | |||
Paraplatin (10 mg/ml) | |||
Pemetrexed (25 mg/ml) | |||
Pertuzumab (30 mg/ml) | |||
Raltitrexed (0.5 mg/ml) | |||
Retrovir (10 mg/ml) | |||
Rituximab (10 mg/ml) | |||
Temsirolimus (25 mg/ml) | |||
Trastuzumab (21 mg/ml) | |||
Topotecan HCL (1 mg/ml) | |||
Triclosan (2 mg/ml) | |||
Trisonex (1.0 mg/ml) | |||
Vincrinstine Sulfate (1 mg/ml) | |||
Vinblastine (1 mg/ml) | |||
Vinorelbine (10 mg/ml) | |||
Zoledronic Acid (0.8 mg/ml) | |||
Carmustine (3.3 mg/ml) No breakthrough up to | |||
54.7 minutes | |||
ThioTEPA (10 mg/ml) No breakthrough up to | |||
128.5 minutes | No signs of breakthrough after 4 | ||
hours for 10 drugs. | |||
Result: Meets acceptance criteria. | |||
No breakthrough up to 240 | |||
minutes: Cisplatin (1 mg/ml) | |||
Cyclophosphamide (20 mg/ml) | |||
Dacarbazine (10 mg/ml) | |||
Doxorubicin HCL (2 mg/ml) | |||
Etoposide (20 mg/ml) | |||
Fluorouracil (50 mg/ml) | |||
Ifosfamide (50 mg/ml) | |||
Mitoxantrone (2 mg/ml) | |||
Paclitaxel (6 mg/ml) | |||
Vincrinstine Sulfate (1 | |||
mg/ml) | |||
Carmustine (3.3 mg/ml) | |||
Not for Use with Carmustine ThioTEPA | |||
(10.0 mg/ml) | |||
Not for Use with ThioTEPA | Similar with different | ||
breakthrough times for | |||
Carmustine and ThioTEPA. |
8
| Summary of
Technological
Characteristic
Comparison | 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
chemotherapy drugs. The subject device was tested for use with 52 drugs and the predicate device was
tested for use with 12 drugs. The color is different between the subject device and the predicate. |
------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
---|
Summary of Non-Clinical Performance Data | ||||||
---|---|---|---|---|---|---|
Test Method | Subject Device: | |||||
K183132 | Test Method | Predicate Device: | ||||
K081089 | Comparison | |||||
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. | ASTM D5151-06 | |||||
Standard Test Method | ||||||
for Detection of Holes in | ||||||
Medical Gloves | Testing of the predicate | |||||
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 D6319-10 | ||||||
Standard | ||||||
Specification for | ||||||
Nitrile | ||||||
Examination | ||||||
Gloves for | ||||||
Medical | ||||||
Applications | 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 with an average before | ||||||
aging of 37.89 MPa and after | ||||||
aging of 39.32 MPa and | ||||||
elongation of 602% before | ||||||
aging and 558% after aging. | ASTM D6319-10 | |||||
Standard Specification | ||||||
for Nitrile Examination | ||||||
Gloves for Medical | ||||||
Applications | The physical dimensions | |||||
of the predicate device | ||||||
are within the limits of the | ||||||
standard and the | ||||||
physical properties of the | ||||||
subject device meet the | ||||||
requirements for tensile | ||||||
strength with a target | ||||||
after aging of 38 MPa | ||||||
and elongation of 550% | ||||||
after aging. | Similar | |||||
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 |