(207 days)
Not Found
No
The 510(k) summary describes disposable medical gloves and their physical and chemical resistance properties. There is no mention of any computational or analytical functions that would involve AI or ML.
No
This device is an exam glove intended to prevent contamination, not to treat or cure a disease or condition. It acts as a barrier, providing protection to both the patient and the examiner.
No
Explanation: The device described is an exam glove intended to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring medical conditions.
No
The device is a physical medical device (exam gloves) and does not contain any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "disposable devices 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 protection during medical procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. The intended use of these gloves does not involve testing samples or providing diagnostic information.
- Device Description: The device description confirms that these are examination gloves, which are a type of personal protective equipment, not a diagnostic tool.
- Performance Studies: The performance studies focus on the physical properties of the gloves (dimensions, strength, freedom from pinholes, etc.) and their resistance to permeation by chemotherapy drugs and Fentanyl Citrate. These are relevant to the protective function of the gloves, not to diagnostic capabilities.
The testing for use with chemotherapy drugs and Fentanyl Citrate is related to the safety and protective capabilities of the gloves when handling these substances, not to any diagnostic function.
N/A
Intended Use / Indications for Use
The Halyard Puple Xtra Steile, Low Dermatitis Potential Nitule Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citateis are disposable devices intended for medical purposes that is worn on the examinel's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05 :
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
Azacıtıdine (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
Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes
Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
Cladiibine (1 0 mg/ml) No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
Cytarabıne 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 breakthıough 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
Ep11 ubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
Etoposide (20 mg/ml) No breakthrough up to 240 minutes
Fludarabıne (25 mg/ml) No breakthrough up to 240 minutes
Fluorouracil (50 mg/ml) No breakthıough 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
Iiinotecan (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 mınutes
Mitoxantıone (2 mg/ml) No breakthrough up to 240 minutes
Oxaliplatın (2 mg/ml) No breaktlı ough up to 240 minutes
Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
Paraplatın (10 mg/ml) No breakthrough up to 240 mınutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml) No breakthrough up to 240 mınutes
Raltitlexed (0.5 mg/ml) No breakthrough up to 240 minutes
Retrovii (10 mg/ml) No breakthrough up to 240 minutes
Rituximab (10 mg/ml) No breakthrough up to 240 minutes
Temsuolimus (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 (1 mg/ml) No breakthrough up to 240 minutes
Trisenox (0.1 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
Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes
Product codes
LZA, LZC, QDO
Device Description
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder- Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves. The devices follow 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 10993-11:2017, 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
examiner's hand
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)
Non-Clinical Tests:
- Dimensions (ASTM D 6319): The physical dimensions of the subject device are within the limits of the standard. Length >= 230mm, Palm width Size Xtra-Small: 60 - 80 mm, Small: 70 - 90 mm, Medium: 85 - 105 mm, Large: 100 - 120 mm, Xtra-Large: 110-130 mm, Finger Thickness >= 0.050 mm, Palm Thickness >= 0.050 mm, Cuff Thickness 0.10-0.13 mm (Halyard).
- Physical Properties (ASTM D 6319): Physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. AQL 4.0. Before Tensile Strength: >= 14 MPa, Ultimate elongation: >= 500%. After Tensile Strength: >= 14 MPa, Ultimate elongation: >= 400%.
- Freedom from Pinholes (ASTM D 6319, ASTM D 5151): Testing of the subject device shows it meets the AQL requirement in the standards for leakage. AQL 2.5%. No leakage.
- Powder-Free (ASTM D 6124, ASTM D 6319): Residual powder on the subject device is within the powder-free limits prescribed in the standards.
§ 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, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 13, 2020
O & M Halyard, Inc. Steven Dowdley Associate Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K192241
Trade/Device Name: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: February 10, 2020 Received: February 12, 2020
Dear Steven Dowdley:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192241 Device Name
The Halyard Puple Xtra Steile, Low Dermatitis Potential Nitule Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citiate
Indications for Use (Describe)
The Halyad Purple Xtra Steile, Low Dermatitis Potental Nutile Powder-Fiee Exam Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citateis are disposable devices intended for medical purposes that is worn on the examinel's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05 :
Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes Azacıtıdine (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 Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 169.8 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladiibine (1 0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cytarabıne 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 breakthıough 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 Ep11 ubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabıne (25 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50 mg/ml) No breakthıough 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 Iiinotecan (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 mınutes Mitoxantıone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatın (2 mg/ml) No breaktlı ough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Paraplatın (10 mg/ml) No breakthrough up to 240 mınutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
3
Pertuzumab (30 mg/ml) No breakthrough up to 240 mınutes Raltitlexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovii (10 mg/ml) No breakthrough up to 240 minutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsuolimus (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 (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 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
Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green.
510(k) Summary – K192241
| Date Summary
| was Prepared | March 12, 2020 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| Primary Contact for | |
| this 510(k) Submission | Steven Dowdley, RAC |
| Tel: 678-451-8062 | |
| Email: steven.dowdley@hyh.com | |
| Device Trade Name | Halyard Purple Xtra Sterile, Low Dermatitis Potential, Powder-Free Exam |
| Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | |
| Halyard Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves | |
| Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZA |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Subsequent Product Codes | LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove, Specialty | |
| QDO | |
| Class I, 21 CFR §880.6250 | |
| Fentanyl and other opioid protection glove | |
| Predicate Device | K102032 |
| KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE | |
| EXAM GLOVE (CHEMOTHERAPY GLOVE) | |
| Subject Device Description | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder- |
| Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | |
| Citrate are disposable, purple-colored, chlorinated, nitrile, powder-free, | |
| textured fingertip, ambidextrous, sterile patient examination gloves. | |
| The devices follow 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 10993-11:2017, 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 |
5
Image /page/5/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, block letters. The design inside the circle appears to be two stylized shapes, one white and one green.
| Indications for Use | | The Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-
Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Citrate are disposable devices 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 and
Fentanyl Citrate as per ASTM -D6978-05:
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
Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) permeation occurred at 169.8 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 (1 mg/ml) No breakthrough up to 240 minutes
Trisenox (0.1 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 |
|---------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes. | | |
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Image /page/6/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, bold letters. The design inside the circle appears to be two curved shapes, one white and one green, resembling sails or stylized mountains.
Technological Characteristics Comparison Table
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K192241 | K102032 | ||
| FDA Product Code | LZA, LZC, QDO | LZC, LZA | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Purple Xtra and | ||
| Purple Sterile, Low | |||
| Dermatitis Potential, | |||
| Powder-Free Exam | |||
| Gloves Tested for Use | |||
| with Chemotherapy | |||
| Drugs and Fentanyl | |||
| Citrate | Kimberly Clark Purple Xtra | ||
| and Purple Sterile, Powder- | |||
| Free Exam Gloves Tested for | |||
| Use with Chemotherapy | |||
| Drugs | Same | ||
| Intended Use | The Halyard Purple Xtra | ||
| and Purple Sterile, Low | |||
| Dermtatis Potential, | |||
| Powder-Free Exam | |||
| Gloves Tested for Use | |||
| with Chemotherapy | |||
| Drugs and Fentanyl | |||
| Citrates are 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. | Kimberly Clark Purple Xtra | ||
| and Purple Sterile, Powder- | |||
| Free Exam Gloves Tested for | |||
| Use with Chemotherapy | |||
| Drugs are 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. | Different | ||
| Technological | |||
| Characteristics | The glove is a colored, | ||
| nitrile, powder-free, | |||
| textured fingertip, | |||
| ambidextrous, patient | |||
| examination glove. | The glove is a colored, nitrile, | ||
| powder-free, textured | |||
| fingertip, ambidextrous, | |||
| patient examination glove. | Same | ||
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | Based ISO 10993 | ||
| Biological evaluation of | |||
| Medical devices - Test | |||
| for Systemic Injection, | |||
| the test article was | |||
| considered non-toxic. | |||
| Meets the acceptance | |||
| criteria. | Based ISO 10993 Biological | ||
| evaluation of Medical devices |
- Test for Systemic Injection,
the test article was
considered non-toxic. Meets
the acceptance criteria. | Same |
| | Based on ISO 10993-
Biological evaluation of
Medical Devices – Test
for Skin Irritation, the
device extracts were not
found to cause a
systemic response in the
animal model. Meets the
acceptance criteria. | Based on ISO 10993-
Biological evaluation of
Medical Devices - Test for
Skin Irritation, the device
extracts were not found to
cause a systemic response in
the animal model. Meets the
acceptance criteria. | |
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Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two curved shapes, one white and one green, creating a stylized image.
8
Image /page/8/Picture/0 description: The image shows the logo for Halyard. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue, sans-serif font. The design inside the circle appears to be two stylized shapes, one white and one green, resembling sails or stylized mountains.
| Standard | Results
Subject Devices | Results
Predicate Devices K102032 | Remarks |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|---------|
| ASTM D6978-05
Standard
Practice for
Assessment of
Resistance of
Medical Gloves
to Permeation by
Chemotherapy
Drugs | Arsenic Trioxide (1 mg/ml) No
breakthrough up to 240 minutes | Bleomycin sulfate (15 mg/ml) No
breakthrough up to 240 minutes | Similar |
| | Azacitidine (Vidaza) (25 mg/ml) No
breakthrough up to 240 minutes | Busulfan (6 mg/ml) No breakthrough up to
240 minutes | |
| | Bendamustine (5 mg/ml) No
breakthrough up to 240 minutes | Carboplatin (10 mg/ml) No breakthrough up
to 240 minutes | |
| | Bortezomib (Velcade) (1 mg/ml) No
breakthrough up to 240 minutes | Carmustine (3.3 mg/ml) permeation
occurred at 48.6 minutes | |
| | Bleomycin sulfate (15 mg/ml) No
breakthrough up to 240 minutes | Cyclophosphamide (20 mg/ml) No
breakthrough up to 240 minutes | |
| | Busulfan (6 mg/ml) No breakthrough up
to 240 minutes | Cytarabine HCL (100 mg/ml) No
breakthrough up to 240 minutes | |
| | Carboplatin (10 mg/ml) No breakthrough
up to 240 minutes | Dacarbazine (10 mg/ml) No breakthrough
up to 240 minutes | |
| | Carfilzomib (2 mg/ml) No breakthrough
up to 240 minutes | Daunorubicin HCL (5 mg/ml) No
breakthrough up to 240 minutes | |
| | Carmustine (3.3 mg/ml) permeation
occurred at 169.8 minutes | Docetaxel (10 mg/ml) No breakthrough up
to 240 minutes | |
| | Cetuximab (Erbitux) (2 mg/ml) No
breakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml) No
breakthrough up to 240 minutes | |
| | Cisplatin (1 mg/ml) No breakthrough up
to 240 minutes | Epirubicin (Ellence) (2 mg/ml) No
breakthrough up to 240 minutes | |
| | Cladribine (1.0 mg/ml) No breakthrough
up to 240 minutes | Etoposide (20 mg/ml) No breakthrough up
to 240 minutes | |
| | Cyclophosphamide (20 mg/ml) No
breakthrough up to 240 minutes | Fludarabine (25 mg/ml) No breakthrough up
to 240 minutes | |
| | Cytarabine HCL (100 mg/ml) No
breakthrough up to 240 minutes | Fluorouracil (50 mg/ml) No breakthrough up
to 240 minutes | |
| | Cytovene (10 mg/ml) No breakthrough
up to 240 minutes | Gemcitabine (38 mg/ml) No breakthrough
up to 240 minutes | |
| | Dacarbazine (10 mg/ml) No
breakthrough up to 240 minutes | Idarubicin (1 mg/ml) No breakthrough up to
240 minutes | |
| | Daunorubicin HCL (5 mg/ml) No
breakthrough up to 240 minutes | Ifosfamide (50 mg/ml) No breakthrough up
to 240 minutes | |
| | Decitabine (5 mg/ml) No breakthrough
up to 240 minutes | Irinotecan (20 mg/ml) No breakthrough up
to 240 minutes | |
| | Docetaxel (10 mg/ml) No breakthrough
up to 240 minutes | Mechlorethamine HCL (1 mg/ml) No
breakthrough up to 240 minutes | |
9
HALYARD
| Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes | Melphalan (5 mg/ml) No breakthrough up to 240 minutes |
|---|---|
| Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes | Methotrexate (25 mg/ml) No breakthrough up to 240 minutes |
| Etoposide (20 mg/ml) No breakthrough up to 240 minutes | Mitomycin (0.5 mg/ml) No breakthrough up to 240 minutes |
| Fludarabine (25 mg/ml) No breakthrough up to 240 minutes | Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes |
| Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes | Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes |
| Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes | Paraplatin (10 mg/ml) No breakthrough up to 240 minutes |
| Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes | Rituximab (10 mg/ml) No breakthrough up to 240 minutes |
| Idarubicin (1 mg/ml) No breakthrough up to 240 minutes | ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes |
| Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes | Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes |
| Irinotecan (20 mg/ml) No breakthrough up to 240 minutes | Vincrinstine Sulfate (1 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 (1 mg/ml) No breakthrough up | |
| to 240 minutes | |
| Trisenox (0.1 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 |
10
HALYARD 11
| Performance Data for Fentanyl Citrate Injection | |||
|---|---|---|---|
| Standard | Results | ||
| Subject Devices | Results | ||
| Predicate Devices K102032 | Remarks | ||
| ASTM D 6978 | Fentanyl Citrate Injection, (100mcg | ||
| /2mL). No breakthrough up to 240 | |||
| minutes | Not tested | Different |
| 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 |
| -------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
|---|
11
Image /page/11/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in blue. The design inside the circle appears to be two curved shapes, one white and one green, resembling stylized sails or mountains.
| 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