(228 days)
Not Found
No
The device is a physical glove and the summary describes its material properties and resistance to chemicals, not any computational or analytical functions.
No
The device is described as disposable exam gloves worn on the hand to prevent contamination, which serves a protective barrier function rather than treating a disease or condition.
No
The device is a medical glove intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device is a physical medical glove, not a software application. The summary describes its material, intended use for preventing contamination, and testing against various chemicals, all indicative of a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states 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 personal protection and infection control during medical procedures.
- IVD Definition: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to diagnose diseases or other conditions. The Halyard Purple Nitrile gloves do not perform any such tests.
- Device Description: The device description confirms it is a "disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove." This aligns with the description of a protective barrier, not a diagnostic tool.
- Performance Studies: The performance studies focus on the glove's resistance to permeation by chemotherapy drugs and hazardous substances, as well as physical properties like hole detection, residual powder, and tensile strength. These are relevant to the glove's function as a protective barrier, not its ability to diagnose conditions.
The testing with chemotherapy drugs and fentanyl is to demonstrate the glove's ability to protect the user from these substances, which is a safety feature for a medical glove, not a diagnostic function.
N/A
Intended Use / Indications for Use
The Halyard Purple 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 and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Azacitidine (25 mg/ml)
Bendamustine HCl (5 mg/ml)
Bleomycin Sulfate (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Capecitabine (26 mg/ml)
Carboplatin (10 mg/ml)
Carlzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Chloroquine (50 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cyclosporin A (100 mg/ml)
Cytarabine (Cytosine) (100 mg/ml)
Cytovene (Ganciclovir) (10 mg/ml)
Dacarbazine (DTIC) (10 mg/ml)
Dactinomycin (0.5 mg/ml)
Daunorubicin HCl (5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCl (2 mg/ml)
Epirubicin HCl (Ellence) (2 mg/ml)
Etoposide (Toposar) (20 mg/ml)
Fludarabine (25 mg/ml)
5-Fluorouracil (50 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine (38 mg/ml)
Idarubicin (1 mg/ml)
Ifosfamide (50 mg/ml)
Irinotecan HCl (20 mg/ml)
Leuprolide Acetate Salt (5 mg/ml)
Mechlorethamine HCl (1 mg/ml)
Melphalan (5 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2 mg/ml)
Oxaliplatin (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCl (1 mg/ml)
Triclosan (2 mg/ml)
Trisenox (1 mg/ml)
Vinblastine Sulfate (1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.
Warning- Not for use with Carmustine and ThioTEPA
No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Product codes (comma separated list FDA assigned to the subject device)
LZA, OPJ, OQD
Device Description
The Halyard Purple Powder-Free Nitrile Exam Glove tested with Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and 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
worn on the examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided based on the following standards:
- 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 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 met the requirements for tensile strength before and after aging. The subject device also met the requirement for elongation before and after aging."
- 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
§ 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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
August 1, 2022
O & M Halyard, Inc. Angela L. Bunn Director, Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K213929
Trade/Device Name: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ, QDO Dated: June 28, 2022 Received: June 30, 2022
Dear Angela Bunn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
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,
Clarence W. Murray, III, Ph.D. Assistant Director 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
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K213929
Device Name
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid Indications for Use (Describe)
The Halvard Purple Nitrile, Powder-Free Exam Gloven intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were the following chemotherapy drugs and Fentany Citrate and Gastric Acid as per ASTM-26978-05
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomvcin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vinorelbine (10 mg/ml) Vincristine (1 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.
Warning- Not for use with Carmustine and ThioTEPA
No breakthrough was detected up to 240 minutes for Fention (100 mg/2 ml) and Simulated Gastric Acid Fluid/Fentany Citrate hijection Mix 50/50 Solution
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
IX] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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 0MB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray.
510(k) Summary
| Date Summary
was Prepared | July 28, 2022 |
---|---|
510(k) Clearance Number | K213929 |
510(k) Submitter | O & M Halyard, Inc. |
1 Edison Drive | |
Alpharetta, GA 30005 | |
Primary Contact for | |
this 510(k) Submission | Angela L. Bunn, RAC |
Tel: 470-364-7147 | |
Email: angela.bunn@owens-minor.com | |
Marketed Common Name | Halyard Purple Nitrile Powder-Free Exam Gloves |
Device Submission Trade Name | |
and Description | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with |
Chemotherapy Drugs, Fentanyl Citrate, and Simulated Gastric Acid | |
Device Common Name | Medical Exam Gloves |
Device Product Code | |
and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove |
OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove | |
OPJ, Class 1, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling | |
Claims - Test For Use With Chemotherapy Drugs | |
Predicate Device | Halyard Purple , Powder-Free Exam Gloves Tested for Use with |
Chemotherapy Drugs (K200633) | |
Subject Device Description | The Halyard Purple Powder-Free Nitrile Exam Glove tested with |
Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a | |
disposable, nitrile, powder-free, textured fingertip, ambidextrous, non- | |
sterile patient examination glove that are chlorinated on the donning side | |
and are packed in a cardboard dispenser box. | |
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 | |
Indications for Use | |
The Halyard Purple 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 and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 : | |
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: | |
Azacitidine (25 mg/ml) | |
Bendamustine HCl (5 mg/ml) | |
Bleomycin Sulfate (15 mg/ml) | |
Bortezomib (1 mg/ml) | |
Busulfan (6 mg/ml) | |
Capecitabine (26 mg/ml) | |
Carboplatin (10 mg/ml) | |
Carlzomib (2 mg/ml) | |
Cetuximab (2 mg/ml) | |
Chloroquine (50 mg/ml) | |
Cisplatin (1 mg/ml) | |
Cladribine (1 mg/ml) | |
Cyclophosphamide (20 mg/ml) | |
Cyclosporin A (100 mg/ml) | |
Cytarabine (Cytosine) (100 mg/ml) | |
Cytovene (Ganciclovir) (10 mg/ml) | |
Dacarbazine (DTIC) (10 mg/ml) | |
Dactinomycin (0.5 mg/ml) | |
Daunorubicin HCl (5 mg/ml) | |
Decitabine (5 mg/ml) | |
Docetaxel (10 mg/ml) | |
Doxorubicin HCl (2 mg/ml) | |
Epirubicin HCl (Ellence) (2 mg/ml) | |
Etoposide (Toposar) (20 mg/ml) | |
Fludarabine (25 mg/ml) | |
5-Fluorouracil (50 mg/ml) | |
Fulvestrant (50 mg/ml) | |
Gemcitabine (38 mg/ml) | |
Idarubicin (1 mg/ml) | |
Ifosfamide (50 mg/ml) | |
Irinotecan HCl (20 mg/ml) | |
Leuprolide Acetate Salt (5 mg/ml) | |
Mechlorethamine HCl (1 mg/ml) | |
Melphalan (5 mg/ml) | |
Methotrexate (25 mg/ml) | |
Mitomycin C (0.5 mg/ml) | |
Mitoxantrone (2 mg/ml) | |
Oxaliplatin (5 mg/ml) | |
Paclitaxel (6 mg/ml) | |
Pemetrexed (25 mg/ml) | |
Raltitrexed (0.5 mg/ml) | |
Retrovir (10 mg/ml) | |
Rituximab (10 mg/ml) | |
Temsirolimus (25 mg/ml) | |
Topotecan HCl (1 mg/ml) | |
Triclosan (2 mg/ml) | |
Trisenox (1 mg/ml) | |
Vinblastine Sulfate (1 mg/ml) | |
Vincristine (1 mg/ml) | |
Vinorelbine (10 mg/ml) | |
Zoledronic Acid (0.8 mg/ml) | |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: | |
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. | |
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. | |
Warning- Not for use with Carmustine and ThioTEPA | |
No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
5
6
Subject Device K213929 | Predicate Device K200633 | Comparison | |
---|---|---|---|
FDA Product Code | OPJ, LZA, OQD | LZC, LZA, OQD | Same |
FDA Classification | Class I | Class I | Same |
Regulation Number | 880.6250 | 880.6250 | Same |
Common Name | Purple Nitrile Exam Glove | Purple Nitrile Exam Glove | Same |
Device Trade Name | Halyard Purple Nitrile, Powder-Free | ||
Exam Gloves Tested for Use with | |||
Chemotherapy Drugs, Fentanyl | |||
Citrate, Simulated Gastric Acid and | |||
Fentanyl in Simulated Gastric Acid | Halyard Purple Nitrile, Powder-Free | ||
Exam Gloves Tested for Use with | |||
Chemotherapy Drugs and Fentanyl | |||
Citrate | Similar | ||
Intended Use | Halyard Purple 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 chemotherapy drugs listed on | |||
the label. | Halyard Purple 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 chemotherapy drugs listed on | |||
the label. | Same |
7
| 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 | Non-Sterile | Non-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 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 ISO 10993 Biological
evaluation of Medical devices –
Test for Systemic Injection, the test
article was considered non-toxic.
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. | Same |
Performance Data for Chemotherapy Drugs | |||
---|---|---|---|
Standard | Results | ||
Subject Device K213929 | Results | ||
Predicate Devices K200633 | Remarks | ||
ASTM 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 chemotherapy drugs.
The following drugs showed not breakthrough at 240 minutes:
Azacitidine (25 mg/ml)
Bendamustine HCl (5 mg/ml)
Bleomycin Sulfate (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Capecitabine (26 mg/ml)
Carboplatin (10 mg/ml)
Carlzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Chloroquine (50 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cyclosporin A (100 mg/ml)
Cytarabine (Cytosine) (100 mg/ml)
Cytovene (Ganciclovir) (10 mg/ml)
Dacarbazine (DTIC) (10 mg/ml)
Dactinomycin (0.5 mg/ml) | No signs of breakthrough after 4 hours for chemotherapy drugs.
The following drugs showed not breakthrough at 240 minutes:
Bleomycin (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (DTIC) (10.0 mg/ml)
Daunorubicin (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin Hydrochloride (2.0 mg/ml)
Ellence (2.0 mg/ml)
Etoposide (Toposar) (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (Gemzar) (38.0 mg/ml)
Idarubicin (1.0 mg/ml) | Similar |
8
Daunorubicin HCl (5 mg/ml) | Ifosfamide (50.0 mg/ml) |
---|---|
Decitabine (5 mg/ml) | Irinotecan (20.0 mg/ml) |
Docetaxel (10 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
Doxorubicin HCl (2 mg/ml) | Melphalan (5.0 mg/ml) |
Epirubicin HCl (Ellence) (2 mg/ml) | Methotrexate (25.0 mg/ml) |
Etoposide (Toposar) (20 mg/ml) | Mitomycin C (0.5 mg/ml) |
Fludarabine (25 mg/ml) | Mitoxantrone (2.0 mg/ml) |
5-Fluorouracil (50 mg/ml) | Paclitaxel (Taxol) (6.0 mg/ml) |
Fulvestrant (50 mg/ml) | Paraplatin (10.0 mg/ml) |
Gemcitabine (38 mg/ml) | Rituximab (10.0 mg/ml) |
Idarubicin (1 mg/ml) | Trisonex (1.0 mg/ml) |
Ifosfamide (50 mg/ml) | Vincrinstine (1mg/ml) |
Irinotecan HCl (20 mg/ml) | Fentanyl Citrate, 100 mcg/2ml |
Leuprolide Acetate Salt (5 mg/ml) | The following drugs showed |
breakthrough detected in less than | |
30 minutes: | |
Mechlorethamine HCl (1 mg/ml) | Carmustine (3.3mg/ml) 1.8 |
minutes | |
Melphalan (5 mg/ml) | ThioTEPA (10.0mg/ml): 1.7 minutes |
Methotrexate (25 mg/ml) | Warning- Not for use with |
Carmustine and ThioTEPA. | |
Mitomycin C (0.5 mg/ml) | |
Mitoxantrone (2 mg/ml) | |
Oxaliplatin (5 mg/ml) | |
Paclitaxel (6 mg/ml) | |
Pemetrexed (25 mg/ml) | |
Raltitrexed (0.5 mg/ml) | |
Retrovir (10 mg/ml) | |
Rituximab (10 mg/ml) | |
Temsirolimus (25 mg/ml) | |
Topotecan HCl (1 mg/ml) | |
Triclosan (2 mg/ml) | |
Trisenox (1 mg/ml) | |
Vinblastine Sulfate (1 mg/ml) | |
Vincristine (1 mg/ml) | |
Vinorelbine (10 mg/ml) | |
Zoledronic Acid (0.8 mg/ml) | |
The following chemotherapy drugs | |
and concentration showed | |
breakthrough detected in less than | |
90 minutes: | |
Carmustine (3.3 mg/ml) No | |
breakthrough up to 55.3 minutes. | |
Thiotepa (10 mg/ml) No | |
breakthrough up to 78.8 minutes. | |
Warning- Not for use with | |
Carmustine and ThioTEPA | |
No breakthrough was detected up | |
to 240 minutes for Fentanyl |
9
| | and Simulated Gastric Acid
Fluid/Fentanyl Citrate Injection
Mix 50/50 Solution | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Performance Data for Hazardous Drugs (opioids) | | |
| ASTM D6978-05
Standard Practice for
Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy
Drugs | The following hazardous drugs
(opioids) and concentration had NO
breakthrough detected up to 240
minutes:
Fentanyl Citrate Injection (100
mcg/2 ml)
Simulated Gastric Acid
Fluid/Fentanyl Citrate Injection Mix
50/50 Solution | The following hazardous drugs
(opioids) and concentration had NO
breakthrough detected up to 240
minutes:
Fentanyl Citrate Injection (100 mcg/2
ml) | Different |
10
Performance Data | |||
---|---|---|---|
ASTM D5151-06 | |||
Standard Test | |||
Method for | |||
Detection of Holes in | |||
Medical Gloves | Testing of the subject device shows | ||
it meets the 2.5% AQL requirement | |||
in the standards for leakage. The | |||
device meets the acceptance criteria | |||
of the standard. | Testing of the subject device shows it | ||
meets the 2.5% AQL requirement in | |||
the standards for leakage. The device | |||
meets the acceptance criteria of the | |||
standard. | Same | ||
ASTM D6124-06 | |||
Standard Test | |||
Method for Residual | |||
Powder on Medical | |||
Gloves | Residual powder on the subject | ||
device is an average of 0.4 mg/glove | |||
within the powder-free limit of |