(97 days)
Not Found
No
The device is a physical examination glove and the description focuses on its material properties and barrier performance against chemicals, with no mention of AI or ML.
No
The device is a disposable exam glove intended to prevent contamination between patients and examiners, not to provide therapy.
No
Explanation: The device is described as a disposable examination glove intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand. It is a tangible hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control.
- Device Description: The description is of a physical barrier device (gloves).
- Performance Studies: The performance studies focus on the physical properties of the gloves (leakage, tensile strength, powder) and their resistance to permeation by certain substances (chemotherapy drugs, fentanyl, gastric acid). These are tests related to the barrier function and safety of the glove itself.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a protective barrier.
N/A
Intended Use / Indications for Use
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Cisplatin (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Dacarbazine (10 mg/ml)
Doxorubicin HCI (2 mg/ml)
Etoposide (20 mg/ml)
Fluorouracil (50 mg/ml)
Ifosfamide (50 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCI (2 mg/ml)
Paclitaxel (6 mg/ml)
Vincrinstine Sulfate (1 mg/ml)
Fentanyl Citrate Injection (100 mcg/2 mL)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO
Device Description
The subject device is a green colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, 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
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)
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
- The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes for the subject device: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCI (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Methotrexate (25 mg/ml), Mitomycin C (0.5 mg/ml), Mitoxantrone HCI (2 mg/ml), Paclitaxel (6 mg/ml), Vincrinstine Sulfate (1 mg/ml), Fentanyl Citrate Injection (100 mcg/2 mL), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution.
- The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes for the subject device: ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes; Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes.
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 2, 2022
೦&M Halyard, Inc. Angela Bunn Director. Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K220541
Trade/Device Name: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: April 28, 2022 Received: May 3, 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,
For Bifeng Oian, Ph D Acting 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)
K220541
Device Name
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
Indications for Use (Describe)
The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
| Cisplatin (1 mg/ml) | Cyclophosphamide (20 mg/ml) |
|---|---|
| Dacarbazine (10 mg/ml) | Doxorubicin HCI (2 mg/ml) |
| Etoposide (20 mg/ml) | Fluorouracil (50 mg/ml) |
| Ifosfamide (50 mg/ml) | Methotrexate (25 mg/ml) |
| Mitomycin C (0.5 mg/ml) | Mitoxantrone HCI (2 mg/ml) |
| Paclitaxel (6 mg/ml) | Vincrinstine Sulfate (1 mg/ml) |
| Fentanyl Citrate Injection (100 mcg/2 mL) | Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
4
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5
510(k) Summary
K220541
| Date Summary
| was Prepared | February 10, 2022 |
|---|---|
| 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: 470-347-7147 | |
| Email: angela.bunn@owens-minor.com | |
| Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| Device Submission Trade Name | |
| and Description | PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, |
| Fentanyl Citrate and Gastric Acid claim | |
| PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy | |
| Drugs, Fentanyl Citrate and Gastric Acid claim | |
| Device Common Name | Patient Examination Gloves |
| Device Product Code | |
| and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove |
| LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty | |
| QDO Class 1, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove | |
| Predicate Device | Halyard Sterling* Nitrile Powder-Free Exam Glove with Chemotherapy Drug |
| and Fentanyl Citrate Claim (K191230) | |
| Subject Device Description | The subject device is a green colored, chlorinated, nitrile, powder-free, |
| textured fingertip, ambidextrous, 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: | |
| Indications for Use | Tests for Irritation and Skin Sensitization |
| The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy | |
| Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile | |
| Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and | |
| Gastric Acid claim is a disposable device intended for medical purposes that is | |
| worn on the examiner's hand to prevent contamination between patient and | |
| examiner. | |
| The following chemotherapy drugs and concentration had NO breakthrough | |
| detected up to 240 minutes: | |
| Cisplatin (1 mg/ml) | |
| Cyclophosphamide (20 mg/ml) | |
| Dacarbazine (10 mg/ml) | |
| Doxorubicin HCI (2 mg/ml) | |
| Etoposide (20 mg/ml) | |
| Fluorouracil (50 mg/ml) | |
| Ifosfamide (50 mg/ml) | |
| Methotrexate (25 mg/ml) | |
| Mitomycin C (0.5 mg/ml) | |
| Mitoxantrone HCI (2 mg/ml) | |
| Paclitaxel (6 mg/ml) | |
| Vincrinstine Sulfate (1 mg/ml) | |
| Fentanyl Citrate Injection (100 mcg/2 mL) | |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| The following chemotherapy drugs and concentration showed breakthrough | |
| detected in less than 90 minutes: | |
| ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes | |
| Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes | |
| Warning: Not for Use With: Carmustine or ThioTEPA |
6
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | |||
| K220541 | Predicate Device | ||
| Halyard Sterling* Nitrile | |||
| Powder-Free Exam Glove | |||
| K191230 | Comparison | ||
| FDA Product Code | LZC, LZA, QDO | LZC | Added LZA and |
| QDO for the | |||
| Fentanyl Claim | |||
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Patient Examination Glove | Patient Examination Glove | Same |
7
| Device Trade Name | PureZero LIMON Nitrile Powder-
Free Exam Gloves with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid claim
PureZero LIMON-XTRA Nitrile
Powder-Free Exam Gloves with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid claim | Halyard Sterling* Nitrile
Powder-Free Exam Gloves with
Chemotherapy Drugs and
Fentanyl Citrate claim | Similar |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intended Use | The device is a disposable device
intended for medical purposes
that is worn on the examiner's
hand to prevent contamination
between patient and examiner.
These gloves were tested for use
with chemotherapy drugs,
fentanyl citrate and gastric acid
as listed on the label. | The device is a disposable
device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between patient
and examiner.
These gloves were tested for
use with chemotherapy drugs
and fentanyl citrate listed on
the label. | Similar
Adding Gastric Acid
Claim |
| 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 |
| Glove Length | PureZero LIMON Nitrile Powder-
Free Exam Gloves with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid claim is
9.5 inches in length
PureZero LIMON-XTRA Nitrile
Powder-Free Exam Gloves with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid claim
is 12 inches in length | Halyard Sterling* Nitrile
Powder-Free Exam Glove with
Chemotherapy Drugs and
Fentanyl Citrate is 9.5 inches in
length | Similar
Adding a longer
length glove |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf Life | 3-year | None | Different |
| Biocompatibility | Based ISO 10993-11 Biological
evaluation of Medical devices -
Test for Systemic Toxicity, the
test article was considered non-
toxic. Meets the acceptance
criteria. | Based ISO 10993-11 Biological
evaluation of Medical devices -
Test for Systemic Toxicity, the
test article was considered non-
toxic. Meets the acceptance
criteria. | Same |
| | Based on ISO 10993-10
Biological evaluation of Medical
Devices - Test for Skin
Irritation, the test article was
considered nonirritating. Meets
the acceptance criteria. | Based on ISO 10993-10
Biological evaluation of Medical
Devices - Test for Skin
Irritation, the test article was
considered nonirritating. Meets
the acceptance criteria. | |
| | Based on ISO 10993-10
Biological evaluation of Medical
Devices - Test for Skin
Sensitization. Under the
conditions of the study
the device is not a sensitizer.
Meets the acceptance criteria. | Based on ISO 10993-10
Biological evaluation of Medical
Devices - Test for Skin
Sensitization. Under the
conditions of the study
the device is not a sensitizer.
Meets the acceptance criteria. | |
8
9
| Standard | Results Subject Device(s) | Results Predicate Device K191230 | Remarks |
|---|---|---|---|
| Standard | PureZero LIMON Nitrile Powder- | ||
| Free Exam Gloves with | |||
| Chemotherapy Drugs, Fentanyl | |||
| Citrate and Gastric Acid claim |
PureZero LIMON-XTRA Nitrile
Powder-Free Exam Gloves with
Chemotherapy Drugs, Fentanyl
Citrate and Gastric Acid claim | Halyard Sterling* Nitrile Powder-
Free Exam Glove with
Chemotherapy Drugs and Fentanyl
Citrate claim | |
| ASTM D6978-05
Standard Practice
for Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy
Drugs | The following chemotherapy drugs
and concentration had NO
breakthrough
detected up to 240 minutes:
Cisplatin (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Dacarbazine (10 mg/ml)
Doxorubicin HCI (2 mg/ml)
Etoposide (20 mg/ml)
Fluorouracil (50 mg/ml)
Ifosfamide (50 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCI (2 mg/ml)
Paclitaxel (6 mg/ml)
Vincrinstine Sulfate (1 mg/ml)
Fentanyl Citrate Injection (100 mcg/2 mL)
Simulated Gastric Acid
Fluid/Fentanyl Citrate Injection
Mix 50/50 Solution | The following chemotherapy drugs
and concentration had NO
breakthrough
detected up to 240 minutes:
Arsenic Trioxide (1 mg/ml)
Doxorubicin HCL (2 mg/ml)
Paclitaxel (6 mg/ml)
Azacitidine (Vidaza) (25 mg/ml)
Epirubicin (Ellence) (2 mg/ml)
Paraplatin (10 mg/ml)
Bendamustine (5 mg/ml)
Eribulin Mesylate (0.5 mg/ml)
Pemetrexed (25 mg/ml)
Bortezomib (Velcade) (1 mg/ml)
Etoposide (20 mg/ml)
Pertuzumab (30 mg/ml)
Bleomycin sulfate (15 mg/ml)
Fludarabine (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Busulfan (6 mg/ml)
Fluorouracil (50 mg/ml)
Retrovir (10 mg/ml)
Carboplatin (10 mg/ml)
Fulvestrant (50 mg/ml)
Rituximab (10 mg/ml)
Carfilzomib (2 mg/ml)
Gemcitabine (38 mg/ml)
Temsirolimus (25 mg/ml)
Cetuximab (Erbitux) (2 mg/ml)
Idarubicin (1 mg/ml)
Trastuzumab (21 mg/ml)
Cisplatin (1 mg/ml)
Ifosfamide (50 mg/ml) | Similar |
| | The following chemotherapy drugs
and concentration showed
breakthrough detected in less than
90 minutes:
ThioTEPA (10 mg/ml), breakthrough
detected at 87.6 minutes
Carmustine (3.3 mg/ml),
breakthrough detected at 34.3
minutes. | | |
10
| Cyclophosphamide (20 mg/ml) | |
|---|---|
| Irinotecan (20 mg/ml) | |
| Triclosan (2 mg/ml) | |
| Cytarabine HCL (100 mg/ml) | |
| Mechlorethamine HCL (1 mg/ml) | |
| Trisonex (1 mg/ml) | |
| Cytovene (10 mg/ml) | |
| Melphalan (5 mg/ml) | |
| Vincrinstine Sulfate (1 mg/ml) | |
| Dacarbazine (10 mg/ml) | |
| Methotrexate (25 mg/ml) | |
| Vinblastine (1 mg/ml) | |
| Daunorubicin HCL (5 mg/ml) | |
| Mitomycin-C (0.5 mg/ml) | |
| Vinorelbine (10 mg/ml) | |
| Decitabine (5 mg/ml) | |
| Mitoxantrone (2 mg/ml) | |
| Zoledronic Acid (0.8 mg/ml) | |
| Docetaxel (10 mg/ml) | |
| Oxaliplatin (2 mg/ml) | |
| ThioTEPA (10 mg/ml), breakthrough | |
| detected at 37.1 minutes | |
| Carmustine (3.3 mg/ml), | |
| breakthrough detected at 22.9 | |
| minutes |
| 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 |