(184 days)
Not Found
No
The device is a disposable medical glove and the summary focuses on its physical properties and resistance to chemotherapy drugs. There is no mention of AI or ML.
No
The device is described as an exam glove intended to prevent contamination between patient and examiner. It is a barrier device, not one that treats or diagnoses a medical condition.
No
The device is described as "disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." Its primary function is protection, not diagnosis. While it is tested for resistance to chemotherapy drugs, this relates to its protective barrier function rather than any diagnostic capability.
No
The device described is a physical medical device (exam gloves) and does not contain any software components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 examinations or procedures.
- IVD Definition: An In Vitro Diagnostic (IVD) 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 purpose of an IVD is to provide information for diagnosis, monitoring, or screening.
- Device Function: The function of these gloves is to provide a physical barrier. They do not perform any tests on biological samples or provide diagnostic information. The testing for chemotherapy drug permeation is a performance characteristic of the barrier function, not a diagnostic test.
Therefore, the Halyard Sterling Nitrile Powder-Free Exam Gloves and Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Halyard Sterling Nitrile Powder-Free Exam Gloves 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:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml). No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes
The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves 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:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves and Halyard STERLING* Nitrile Powder-Free Exam Gloves tested for Use with Chemotherapy Drugs are disposable, grey-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
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data for Chemotherapy Drugs:
Standard: ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves: Tested with 52 chemotherapy drugs. For 50 drugs, no breakthrough was observed up to 240 minutes. For ThioTEPA (10 mg/ml), breakthrough was detected at 23.9 minutes. For Carmustine (3.3 mg/ml), breakthrough was detected at 14.8 minutes.
Halyard Sterling Nitrile Powder-Free Exam Gloves: Tested with 52 chemotherapy drugs. For 50 drugs, no breakthrough was observed up to 240 minutes. For ThioTEPA (10 mg/ml), breakthrough was detected at 37.1 minutes. For Carmustine (3.3 mg/ml), breakthrough was detected at 22.9 minutes.
Predicate K180646: No signs of breakthrough after 4 hours for 10 drugs. Carmustine showed no signs of breakthrough until 0.3 minutes. Thiotepa showed no signs of breakthrough until 30.9 minutes.
Summary of Non-Clinical Data:
Standard: ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves.
Results for both subject devices: Meets the 2.5% AQL requirement for leakage. Pass.
Standard: ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves.
Results for both subject devices: Average of 0.03 mg/glove, within the
§ 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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2019
O & M Halyard, Inc. Steve Dowdley Associate Director of Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K191230
Trade/Device Name: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZC Dated: July 19, 2019 Received: August 13, 2019
Dear Steve 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 (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 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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191230
Device Name
Halyard Sterling Nitrile Powder-Free Exam Gloves
Indications for Use (Describe)
The Halyard Sterling Nitrile Powder-Free Exam Gloves 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:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
3
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml). No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K191230
Device Name
Halyard Sterling SG * Nitrile Sensi-Guard Powder-Free Exam Gloves
Indications for Use (Describe)
The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves 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:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml). No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
5
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml).No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Image /page/6/Picture/0 description: The image shows the logo for Halyard, which is part of the Owens & Minor Family. The logo consists of a circular emblem with a stylized white and green shape inside, followed by the word "HALYARD" in bold, dark blue letters. Below the company name, the text "Part of the Owens & Minor Family" is written in a smaller, lighter font.
510(k) Summary
| Date Summary
| was Prepared | Nov 4, 2019 |
|---|---|
| 510(k) Submitter | Owens & Minor Halyard, Inc |
| 9120 Lockwood Blvd | |
| Mechanicsville, VA 23116 | |
| Primary Contact for | |
| this 510(k) Submission | Steven Dowdley, RAC |
| Tel: 678-451-8062 | |
| Email: steven.dowdley@hyh.com | |
| Device Trade Name | Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
| and | |
| Halyard STERLING* Nitrile Powder-Free Exam Gloves | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Predicate Device | K180646 |
| Halyard Lavender Nitrile Powder-Free Exam Gloves | |
| Subject Device Description | Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free |
| Exam Gloves and Halyard STERLING* Nitrile Powder-Free | |
| Exam Gloves tested for Use with Chemotherapy Drugs are | |
| disposable, grey-colored, chlorinated, nitrile, powder-free, | |
| textured fingertip, ambidextrous, non-sterile patient | |
| examination gloves that are packed in a cardboard | |
| dispenser box. |
7
Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue, block letters. Below the word "HALYARD" is the phrase "Part of the Owens & Minor Family" in a smaller font.
| Indications for Use for
Halyard Sterling SG* Nitrile
Sensi-Guard Powder-Free
Exam Gloves | The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves 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: |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes |
| | Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes |
| | Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes |
| | Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes |
| | Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes |
| | Paraplatin (10 mg/ml), No breakthrough up to 240 minutes |
| | Bendamustine (5 mg/ml), No breakthrough up to 240 minutes |
| | Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes |
| | Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes |
| | Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes |
| | Etoposide (20 mg/ml), No breakthrough up to 240 minutes |
| | Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes |
| | Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes |
| | Fludarabine (25 mg/ml), No breakthrough up to 240 minutes |
| | Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes |
| | Busulfan (6 mg/ml), No breakthrough up to 240 minutes |
| | Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, No
breakthrough up to 240 minutes |
| | Retrovir (10 mg/ml) No breakthrough up to 240 minutes |
| | Carboplatin (10 mg/ml), No breakthrough up to 240 minutes |
| | Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes |
| | Rituximab (10 mg/ml), No breakthrough up to 240 minutes |
| | Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes |
| | Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes |
| | Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes |
| | Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes |
| | Idarubicin (1 mg/ml), No breakthrough up to 240 minutes |
| | Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes |
| | Cisplatin (1 mg/ml), No breakthrough up to 240 minutes |
| | Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes |
| | Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes |
| | Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes |
| | Irinotecan (20 mg/ml), No breakthrough up to 240 minutes |
| | Triclosan (2 mg/ml), No breakthrough up to 240 minutes |
| | Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes |
| | Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes |
| | Trisonex (1 mg/ml), No breakthrough up to 240 minutes |
| | Cytovene (10 mg/ml), No breakthrough up to 240 minutes |
| | Melphalan (5 mg/ml), No breakthrough up to 240 minutes |
| | Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes |
| | Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes |
| | |
| Methotrexate (25 mg/ml), No breakthrough up to 240 minutes,
Vinblastine (1 mg/ml), No breakthrough up to 240 minutes
Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes
Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes
Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes
Decitabine (5 mg/ml), No breakthrough up to 240 minutes
Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes
Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes
Docetaxel (10 mg/ml), No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes | |
| | |
| | |
| Indications for Use for
Halyard Sterling Nitrile
Powder-Free Exam Gloves | The Halyard STERLING* Nitrile Powder-Free Exam Gloves Tested for Use with
Chemotherapy Drugs 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: |
| | Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes
Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes
Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes
Paraplatin (10 mg/ml), No breakthrough up to 240 minutes
Bendamustine (5 mg/ml), No breakthrough up to 240 minutes
Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes
Etoposide (20 mg/ml), No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes
Fludarabine (25 mg/ml), No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes
Busulfan (6 mg/ml),No breakthrough up to 240 minutes
|
| | Cisplatin (1 mg/ml), No breakthrough up to 240 minutes
Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes
Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes
Irinotecan (20 mg/ml), No breakthrough up to 240 minutes
Triclosan (2 mg/ml), No breakthrough up to 240 minutes
Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes
Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes
Trisonex (1 mg/ml), No breakthrough up to 240 minutes
Cytovene (10 mg/ml), No breakthrough up to 240 minutes
Melphalan (5 mg/ml), No breakthrough up to 240 minutes
Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes |
| | Methotrexate (25 mg/ml), No breakthrough up to 240 minutes |
| | Vinblastine (1 mg/ml), No breakthrough up to 240 minutes |
| | Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes |
| | Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes |
| | Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes |
| | Decitabine (5 mg/ml), No breakthrough up to 240 minutes |
| | Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes |
| | Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes |
| | Docetaxel (10 mg/ml), No breakthrough up to 240 minutes |
| | Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes |
| | ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes |
| | Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes |
| Summary of comparison of
technological characteristics | Both the subject devices and the predicate devices are sterile,
powder-free nitrile exam gloves tested for resistance to permeation
by chemotherapy drugs. |
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Image /page/9/Picture/0 description: The image shows the logo for Halyard. The logo consists of a circular emblem with a stylized image of a house in white and green, followed by the word "HALYARD" in bold, dark blue letters. Below the name, it says "Part of the Owens & Minor Family" in a smaller font.
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Image /page/10/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue. Below the word "HALYARD" is the phrase "Part of the Owens & Minor Family" in a smaller font.
| Technological Characteristics Table | ||||
|---|---|---|---|---|
| Subject Device | ||||
| Halyard Sterling | ||||
| SG* Nitrile Sensi- | ||||
| Guard Powder- | ||||
| Free Exam Gloves | Subject Device | |||
| Halyard Sterling | ||||
| Nitrile Powder- | ||||
| Free Exam Gloves | Predicate | |||
| K180646 | Comparison | |||
| FDA Product Code | LZC | LZC | LZC | Same |
| FDA Classification | Class I | Class I | Class I | Same |
| Regulation | 880.6250 | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam | Medical Exam Glove | Medical Exam | Same |
| Device Trade Name | Halyard Sterling | |||
| SG* Nitrile Sensi- | ||||
| Guard Powder- | ||||
| Free Exam Gloves | Halyard Sterling | |||
| Nitrile Powder-Free | ||||
| Exam Gloves | Halyard Lavender | |||
| Nitrile Powder- | ||||
| Free Exam Gloves | Similar | |||
| Characteristics | Grey- colored, 9.5 | |||
| inch, nitrile, 0.08 | ||||
| mm thick at palm, | ||||
| powder-free, | ||||
| textured fingertips, | ||||
| ambidextrous, non- | ||||
| sterile patient | ||||
| examination glove | Grey- colored, 9.5 | |||
| inch, nitrile, 0.08 | ||||
| mm thick at palm, | ||||
| powder-free, | ||||
| textured fingertips, | ||||
| ambidextrous, non- | ||||
| sterile patient | ||||
| examination glove | Lavender-colored, | |||
| 9.5 inch, nitrile, | ||||
| 0.08 mm thick at | ||||
| palm, powder-free, | ||||
| textured fingertips, | ||||
| ambidextrous, non- | ||||
| sterile patient | ||||
| examination glove | Similar | |||
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | XS, S, M, L, XL | Same |
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Image /page/11/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue. Below the word "HALYARD" is the text "Part of the Owens & Minor Family".
| Texture | Textured fingertips | Textured finger tips | Textured finger tips | Same |
|---|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Summary of | ||||
| comparison of | ||||
| technological | ||||
| characteristics | There are no different technological characteristics of the subject devices, | |||
| (Halyard of technological Sterling SG* Nitrile Sensi-Guard Powder-Free Exam | ||||
| Gloves and Halyard STERLING* Nitrile Powder-Free Exam Gloves) compared to | ||||
| the predicate device. They are powder-free nonsterile nitrile exam gloves | ||||
| tested for resistance to permeation by chemotherapy drugs. The subject | ||||
| devices were tested for use with 52 drugs and the predicate device was tested | ||||
| for use with 12 drugs. The color and thickness profile are different between | ||||
| the subject devices and the predicate device. |
| Performance Data for Chemotherapy Drugs | ||||
|---|---|---|---|---|
| Standard | Subject Device Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | Subject Device Halyard Sterling Nitrile Powder-Free Exam Gloves | Predicate K180646 | Comparison |
| ASTM D6978-05 | ||||
| Standard Practice for | ||||
| Assessment of Medical | ||||
| Gloves to Permeation | ||||
| by Chemotherapy Drugs | Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes | Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes | No signs of breakthrough after 4 hours for 10 drugs. | Similar |
| Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes | Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes | Carmustine showed no signs of breakthrough until 0.3 minutes | ||
| Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes | Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes | Thiotepa showed no signs of breakthrough until 30.9 minutes. | ||
| Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes | Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes | Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes | ||
| Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes | Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes | Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes |
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Image /page/12/Picture/0 description: The image contains the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in large, bold, blue letters. Below the word "HALYARD" is the text "Part of the Owens & Minor Family" in a smaller font size.
| Paraplatin (10 mg/ml), No breakthrough up to 240 minutes | Paraplatin (10 mg/ml), No breakthrough up to 240 minutes | Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes |
|---|---|---|
| Bendamustine (5 mg/ml), No breakthrough up to 240 minutes | ||
| Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes | Bendamustine (5 mg/ml), No breakthrough up to 240 minutes | |
| Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes | 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes | |
| Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes | ||
| Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes | Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes | Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes |
| Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes | Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes | Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes |
| Etoposide (20 mg/ml), No breakthrough up to 240 minutes | Etoposide (20 mg/ml), No breakthrough up to 240 minutes | Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes |
| Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes | Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes | Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes |
| Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes | Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes | Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes |
| Fludarabine (25 mg/ml), No breakthrough up to 240 minutes | Fludarabine (25 mg/ml), No | Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes |
| Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes | ||
| Busulfan (6 mg/ml),No breakthrough up to 240 minutes | ||
| Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes | ||
| Retrovir (10 mg/ml) No breakthrough up to 240 minutes | ||
| Carboplatin (10 mg/ml), No breakthrough up to 240 minutes | ||
| Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes | ||
| Rituximab (10 mg/ml), No breakthrough up to 240 minutes | ||
| Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes | ||
| Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes | breakthrough up to 240 minutes | |
| Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes | ||
| Busulfan (6 mg/ml),No breakthrough up to 240 minutes | ||
| Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, | ||
| Retrovir (10 mg/ml) No breakthrough up to 240 minutes | ||
| Carboplatin (10 mg/ml), No breakthrough up to 240 minutes | ||
| Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes | ||
| Rituximab (10 mg/ml), No breakthrough up to 240 minutes | ||
| Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes | ||
| Gemcitabine (38 mg/ml) No | ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes | |
| Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes | breakthrough up to 240 minutes | |
| Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes | ||
| Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes | Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes | |
| Idarubicin (1 mg/ml), No breakthrough up to 240 minutes | Idarubicin (1 mg/ml), No breakthrough up to 240 minutes | |
| Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes | Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes | |
| Cisplatin (1 mg/ml), No breakthrough up to 240 minutes | Cisplatin (1 mg/ml), No breakthrough up to 240 minutes | |
| Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes | Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes | |
| Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes | Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes | |
| Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes | Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes | |
| Irinotecan (20 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Irinotecan (20 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes | ||
| Triclosan (2 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Triclosan (2 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes | ||
| Cytarabine HCL | ||
| (100 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Cytarabine HCL | |
| (100 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Mechlorethamine | ||
| HCL (1 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Mechlorethamine | |
| HCL (1 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Trisonex (1 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Trisonex (1 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes | ||
| Cytovene (10 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Cytovene (10 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes | ||
| Melphalan (5 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Melphalan (5 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes | ||
| Vincrinstine | ||
| Sulfate (1 mg/ml), | ||
| No breakthrough | ||
| up to 240 minutes | Vincrinstine | |
| Sulfate (1 mg/ml), | ||
| No breakthrough | ||
| up to 240 minutes | ||
| Dacarbazine (10 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Dacarbazine (10 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Methotrexate (25 | ||
| mg/ml) No | ||
| breakthrough up | ||
| to 240 minutes, | Methotrexate (25 mg/ml), No | |
| breakthrough up | ||
| to 240 minutes, | ||
| Vinblastine (1 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Vinblastine (1 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Daunorubicin HCL | ||
| (5 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Daunorubicin HCL | |
| (5 mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Mitomycin-C (0.5 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Mitomycin-C (0.5 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Vinorelbine (10 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Vinorelbine (10 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Decitabine (5 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Decitabine (5 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Mitoxantrone (2 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Mitoxantrone (2 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Zoledronic Acid | ||
| (0.8 mg/ml),No | ||
| breakthrough up | ||
| to 240 minutes | Zoledronic Acid | |
| (0.8 mg/ml),No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Docetaxel (10 | ||
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | Docetaxel (10 | |
| mg/ml), No | ||
| breakthrough up | ||
| to 240 minutes | ||
| Oxaliplatin (2 | ||
| mg/ml) No | ||
| breakthrough up | ||
| to 240 minutes |
ThioTEPA (10 mg/ml),
breakthrough
detected at 23.9
minutes
Carmustine (3.3
mg/ml),
breakthrough
detected at 14.8
minutes | Oxaliplatin (2
mg/ml), No
breakthrough up
to 240 minutes
ThioTEPA (10
mg/ml),
breakthrough
detected at 37.1
minutes
Carmustine (3.3
mg/ml),
breakthrough
detected at 22.9
minutes | |
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Image /page/13/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 large, bold, dark blue letters. Below the word "HALYARD" is the text "Part of the Owens & Minor Family" in a smaller font size.
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Image /page/16/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue. Below the word "HALYARD" is the text "Part of the Owens & Minor Family" in a smaller font.
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Image /page/17/Picture/0 description: The image contains the Halyard logo. The logo features a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue, block letters. Below the word "HALYARD" is the text "Part of the Owens & Minor Family" in a smaller, lighter font.
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Image /page/18/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green shape inside, followed by the word "HALYARD" in blue. Below the word "HALYARD" is the text "Part of the Owens & Minor Family" in a smaller font size.
| Summary of Non-Clinical Data | ||||
|---|---|---|---|---|
| Standard | Subject Device | |||
| Halyard Sterling SG* | ||||
| Nitrile Sensi-Guard | ||||
| Powder-Free Exam | ||||
| Gloves | Subject Device | |||
| Halyard Sterling | ||||
| Nitrile Powder-Free | ||||
| Exam Gloves | Acceptance | |||
| Criteria | Results of | |||
| Subject | ||||
| Devices | ||||
| 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. | Must meet an AQL | |||
| of 2.5% for | ||||
| leakage. | Pass | |||
| ASTM D6124-06 | ||||
| Standard Test | ||||
| Method for | ||||
| Residual Powder | ||||
| on Medical | ||||
| Gloves | Residual powder on | |||
| the subject device is | ||||
| an average of 0.03 | ||||
| mg/glove within the | ||||
| powder-free limit of |