(292 days)
Not Found
No
The document describes a standard medical examination glove and its physical properties and testing, with no mention of AI or ML.
No
The device is a medical examination glove, which is a barrier to prevent contamination, not a device that applies therapy or treatment to a patient.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner and for protection against chemotherapy drugs. It is not designed to diagnose any medical condition.
No
The device is a physical glove made of Nitrile Butadiene Rubber, clearly described as a disposable hardware product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner." This is a barrier device, not a device used to analyze specimens.
- Device Description: The description focuses on the physical properties of the glove (material, color, powder-free, non-sterile) and its function as a barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information. The testing performed (biocompatibility, chemotherapy drug permeation) relates to the glove's protective function, not its diagnostic capability.
This device is a medical glove, specifically a patient examination glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
Product codes
LZA, LZC
Device Description
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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)
No clinical testing was performed.
Nonclinical testing was performed based on the following standards:
- ASTM D6319-10 for accurate sizing, tensile conforming properties, and glove integrity (Freedom from Holes and Residual powder). All tests passed.
- ISO 10993-10 for Primary Skin Irritation Test and Dermal Sensitization Assay (Biocompatibility: Skin irritation and sensitivity). Both tests passed, indicating not a primary skin irritant or contact sensitizer.
- ISO 10993-11 for Acute Systemic toxicity Study (Biocompatibility: acute systemic toxicity). The test passed, indicating not toxic under the conditions.
- AAMI 11737-1 for Open box testing (Demonstrate acceptable open box bioburden). The test passed.
- ASTM D6978-5 (2013) for Resistance against Chemotherapy Drugs. 26 out of 29 tested chemotherapy drugs showed a breakthrough greater than 240 minutes. Carmustine showed a breakthrough at 73.7 minutes, and ThioTepa at 25.4 minutes. Warning: Do not use with Carmustine or ThioTepa.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Tensile Strength (MPa): 14 min (Before and After Aging)
- Ultimate Elongation (%): 500 min (Before Aging), 400 min (After Aging)
- Freedom from Holes (AQL): 2.5 Inspection Level G-1
- Residual Powder: ≤ 2.0 mg/pc
- Chemotherapy drug permeation breakthrough times (Minimum Breakthrough, detection time in minutes):
- Blenoxane (15.0 mg/ml) 15,000 ppm: >240 minutes
- Busulfan (6.0 mg/ml) 6,000 ppm: >240 minutes
- Carboplatin (10.0 mg/ml) 10,000 ppm: >240 minutes
- Carmustine (3.3 mg/ml) 3,300 ppm: 73.7 minutes
- Cisplatin (1.0 mg/ml) 1,000 ppm: >240 minutes
- Cyclophosphamide (20.0 mg/ml) 20,000 ppm: >240 minutes
- Cytarabine (100.0 mg/ml) 100,000 ppm: >240 minutes
- Dacarbazine (10.0 mg/ml) 10,000 ppm: >240 minutes
- Daunorubicin HCl (5.0 mg/ml) 5,000 ppm: >240 minutes
- Docetaxel (10.0 mg/ml) 10,000 ppm: >240 minutes
- Doxorubicin HCl (2.0 mg/ml) 2,000 ppm: >240 minutes
- Epirubicin HCl (2.0 mg/ml) 2,000 ppm: >240 minutes
- Etoposide (20.0 mg/ml) 20,000 ppm: >240 minutes
- Fludarabine (25.0 mg/ml) 25,000 ppm: >240 minutes
- Fluorouracil (50.0 mg/ml) 50,000 ppm: >240 minutes
- Gemcitabine (38.0 mg/ml) 38,000 ppm: >240 minutes
- Idarubicin HCl (1.0 mg/ml) 1,000 ppm: >240 minutes
- Ifosfamide (50.0 mg/ml) 50,000 ppm: >240 minutes
- Irinotecan (20.0 mg/ml) 20,000 ppm: >240 minutes
- Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm: >240 minutes
- Melphalan (5.0 mg/ml) 5,000 ppm: >240 minutes
- Methotrexate (25.0 mg/ml) 25,000 ppm: >240 minutes
- Mitomycin C (0.5 mg/ml) 500 ppm: >240 minutes
- Mitoxantrone (2.0 mg/ml) 2,000 ppm: >240 minutes
- Paclitaxel (6.0 mg/ml) 6,000 ppm: >240 minutes
- Rituximab (10.0 mg/ml) 10,000 ppm: >240 minutes
- ThioTepa (10.0 mg/ml) 10,000 ppm: 25.4 minutes
- Trisenox (1.0 mg/ml) 1,000 ppm: >240 minutes
- Vincristine Sulfate (1.0 mg/ml) 1,000 ppm: >240 minutes
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 19, 2022
Showa Best Glove, Inc. Jeffrey Richardson Director of Operations 579 Edison Street Menlo, Georgia 30731
Re: K211003
Trade/Device Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: December 8, 2021 Received: December 9, 2021
Dear Jeffrey Richardson:
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 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
1
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 mediation-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, PhD 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
510(k) Number (if known) K211003
Device Name
SHOWA®Blue Nitrile Powder Free Medical Examination Glove
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
Chemotherapy Drugs and Concentration Minimum breakthrough detection time (Min) ug/cm2/min Chemotherapy Drug and concentration Minimum Breakthrough, detection time in minutes, minutes 1) Blenoxane (15.0 mg/ml) 15,000 ppm >240 minutes 2) Busulfan (6.0 mg/ml) 6,000 ppm >240 minutes 3) Carboplatin (10.0 mg/ml) 10,000 ppm >240 minutes 4) Carmustine (3.3 mg/ml) 3,300 ppm 73.7 minutes 5) Cisplatin (1.0 mg/ml) 1,000 ppm >240 minutes 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm >240 minutes 7) Cytarabine (100.0 mg/ml) 100,000 ppm >240 minutes 8) Dacarbazine (10.0 mg/ml) 10,000 ppm >240 minutes 9) Daunorubicin HCl (5.0 mg/ml) 5,000 ppm >240 minutes 10) Docetaxel (10.0 mg/ml) 10,000 ppm >240 minutes l 1) Doxorubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 12) Epirubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 13) Etoposide (20.0 mg/ml) 20,000 ppm >240 minutes 14) Fludarabine (25.0 mg/ml) 25.000 ppm >240 minutes 15) Fluorouracil (50.0 mg/ml 50,000 ppm >240 minutes 16) Gemcitabine (38.0 mg/ml) 38,000 ppm >240 minutes 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm >240 minutes 18) Ifosfamide (50.0 mg/ml) 50,000 ppm >240 minutes 19) Irinotecan (20.0 mg/ml) 20,000 ppm >240 minutes 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm >240 minutes 21) Melphalan (5.0 mg/ml) 5,000 ppm >240 minutes 22) Methotrexate (25.0 mg/ml) 25,000 ppm >240 minutes 23) Mitomycin C (0.5 mg/ml) 500 ppm >240 minutes 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm >240 minutes 25) Paclitaxel (6.0 mg/ml) 6,000 ppm >240 minutes 26) Rituximab (10.0 mg/ml) 10,000 ppm >240 minutes 27) ThioTepa (10.0 mg/ml)10,000 ppm 25.4 minutes 28) Trisenox (1.0 mg/ml) 1,000 ppm >240 minutes 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm >240 minutes The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.
. ..
3
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary K211003 DATE OF PREPARATION: January 14, 2022
I. SUBMITTER
Showa Best Glove, Inc. 579 Edison Street Menlo. GA 30731 Tel: 706-862-6740 Fax: 706-862-6000
II. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6740 Fax: 706-862-6000 Email: Bmoseley@showagroup.com
III. 510(K) PREPARER
Brian Moseley Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6752 Fax: 706-862-2660 Email: Bmoseley@showagroup.com
IV.PROPOSED DEVICE
Trade Name/Proprietary Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Common or Usual Name: Nitrile Patient Examination Glove Classification Name: Patient Examination Glove Regulation: 21 CFR 880.6250 Device Classification: Class: I Product Code: LZA, LZC
5
V. PREDICATE DEVICE
Device Classification Name: Polymer Patient Examination Glove 510(k) Number: K200581 Product Code: LZA, LZC Applicant: Hartelega NGC SDN.BHD. Kawasan Perindustrian Tanjung Sepang, MY 43900
VI.DEVICE DESCRIPTION
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
VII. INDICATIONS FOR USE
A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drug and concentration | Minimum Breakthrough, detection
time in minutes, minutes |
|---------------------------------------------|-------------------------------------------------------------|
| 1) Blenoxane (15.0 mg/ml) 15,000 ppm | >240 |
| 2) Busulfan (6.0 mg/ml) 6,000 ppm | >240 |
| 3) Carboplatin (10.0 mg/ml) 10,000 ppm | >240 |
| 4) Carmustine (3.3 mg/ml) 3,300 ppm | 73.7 |
| 5) Cisplatin (1.0 mg/ml) 1,000 ppm | >240 |
| 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm | >240 |
| 7) Cytarabine (100.0 mg/ml) 100,000 ppm | >240 |
| 8) Dacarbazine (10.0 mg/ml) 10,000 ppm | >240 |
| 9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm | >240 |
| 10) Docetaxel (10.0 mg/ml) 10,000 ppm | >240 |
| 11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm | >240 |
| 12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm | >240 |
| 13) Etoposide (20.0 mg/ml) 20,000 ppm | >240 |
| 14) Fludarabine (25.0 mg/ml) 25,000 ppm | >240 |
6
| 15) Fluorouracil (50.0 mg/ml 50,000 ppm | >240 |
|---|---|
| 16) Gemcitabine (38.0 mg/ml) 38,000 ppm | >240 |
| 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm | >240 |
| 18) Ifosfamide (50.0 mg/ml) 50,000 ppm | >240 |
7
| 19) Irinotecan (20.0 mg/ml) 20,000 ppm | >240 |
|---|---|
| 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm | >240 |
| 21) Melphalan (5.0 mg/ml) 5,000 ppm | >240 |
| 22) Methotrexate (25.0 mg/ml) 25,000 ppm | >240 |
| 23) Mitomycin C (0.5 mg/ml) 500 ppm | >240 |
| 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm | >240 |
| 25) Paclitaxel (6.0 mg/ml) 6,000 ppm | >240 |
| 26) Rituximab (10.0 mg/ml) 10,000 ppm | >240 |
| 27) ThioTepa (10.0 mg/ml)10,000 ppm | 25.4 |
| 28) Trisenox (1.0 mg/ml) 1,000 ppm | >240 |
| 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm | >240 |
The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VIII.
| Proposed Device | Predicate Device | Comparison | |||
|---|---|---|---|---|---|
| Characteristics | SHOWA® Blue Nitrile Powder Free Medical | ||||
| Examination Glove K211003 | Polymer Patient Examination Glove | ||||
| 510(k) Number K200581 | |||||
| Device | |||||
| Description/ | |||||
| Regulation | |||||
| Number | Patient examination glove 21 CFR § 880.6250 | Patient examination glove 21 CFR § | |||
| 880.6250 | Same | ||||
| Product Code | LZA, LZC | LZA, LZC, QDO | Similar | ||
| Indications for | |||||
| Use | A patient examination | ||||
| glove is a disposable | |||||
| device intended for | |||||
| medical purposes that is | |||||
| worn on the examiner's | |||||
| hands or fingers to | |||||
| prevent contamination | |||||
| between patient and | |||||
| examiner. | |||||
| These gloves were | |||||
| tested for use with | |||||
| chemotherapy drugs in | |||||
| accordance with ASTM | |||||
| D6978-05 Standard | |||||
| Practice for Assessment | |||||
| of Medical Glove to | |||||
| Permeation by | |||||
| chemotherapy drugs. | |||||
| Chemotherapy Drugs and | |||||
| Concentration |
- Blenoxane (15.0 mg/ml)
15,000 ppm - Busulfan (6.0 mg/ml) 6,000
ppm - Carboplatin (10.0 mg/ml)
10,000 ppm - Carmustine (3.3 mg/ml)
3,300 ppm | Minimum
Breakthrough,
detection time in
minutes, minutes
240 minutes
240 minutes
240 minutes
73.7 minutes | Biodegradable Nitrite Powder Free
Examination Gloves Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate (Blue) is a non-sterile disposable
device intended for medical purpose that
is worn on the examiner's hand to prevent
contamination between patient and
examiner. It is also tested to be used
against Chemotherapy Drugs and
Fentanyl Citrate, These gloves were
tested for use with chemotherapy drugs
and Fentanyl Citrate as per ASTM
D6978-05 (Reapproved 2013) Standard
Practice for Assessment of Medical
Gloves to Permeation by Chemotherapy
Drugs.
Chemotherapy Drug and
Concentration
Carmustine (3.3 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0
mg/ml)
Dacarbazine (10.0 mg/ml)
Doxorubicin Hydrochloride
(2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Methotrexate (25.0 mg/ml) | Minimum
Breakthrough
Detection
Time in
Minutes
21.4
240
240
240
240
240
240
240 | Similar |
8
| 5) Cisplatin (1.0 mg/ml) 1,000 ppm | >240 minutes | Paclitaxel (6.0 mg/ml) | >240 |
|---|---|---|---|
| 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm | >240 minutes | Thiotepa (10.0 mg/ml) | 67.2 |
| 7) Cytarabine (100.0 mg/ml) | >240 minutes | Vincristine Sulfate (1.0 mg/ml) | >240 |
| Azacytidine (25.0 mg/ml) | >240 |
9
| 100,000 ppm | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 8) Dacarbazine (10.0 mg/ml) | |||||||||
| 10,000 ppm | >240 minutes | Carboplatin (10.0 mg/ml) | >240 | ||||||
| 9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm | >240 minutes | Docetaxel (10 mg/ml) | >240 | ||||||
| 10) Docetaxel (10.0 mg/ml) 10,000 ppm | >240 minutes | Epirubicin (2.0 mg/ml) | >240 | ||||||
| 11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm | >240 minutes | Gemcitabine (38 mg/ml) | >240 | ||||||
| 12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm | >240 minutes | Ifosfamide (50 mg/ml) | >240 | ||||||
| 13) Etoposide (20.0 mg/ml) 20,000 ppm | >240 minutes | Irinotecan (20 mg/ml) | >240 | ||||||
| 14) Fludarabine (25.0 mg/ml) 25,000 ppm | >240 minutes | Mitoxantrone (2.0 mg/ml) | >240 | ||||||
| 15) Fluorouracil (50.0 mg/ml 50,000 ppm | >240 minutes | Oncovin (1.0 mg/ml) | >240 | ||||||
| 16) Gemcitabine (38.0 mg/ml) 38,000 ppm | >240 minutes | Oxaliplatin (5 mg/ml) | >240 | ||||||
| 17) Idarubicin HCI (1.0 mg/ml) 1,000 ppm | >240 minutes | Vinorelbine () 0 mg/ml) | >240 | ||||||
| 18) Ifosfamide (50.0 mg/ml) 50,000 ppm | >240 minutes | Please note that Carmustine and Thiotepa have extremely low penetration times of 21.4 minutes and 67.2 minutes respectively. | |||||||
| Warning: Do not use with Carmustine | |||||||||
| 19) Irinotecan (20.0 mg/ml) 20,000 ppm | >240 minutes | ||||||||
| 20) Mechlorethamine HCI (1.0 mg/ml) 1,000 ppm | >240 minutes | ||||||||
| 21) Melphalan (5.0 mg/ml) 5,000 ppm | >240 minutes | ||||||||
| 22) Methotrexate (25.0 mg/ml) 25,000 ppm | >240 minutes | ||||||||
| 23) Mitomycin C (0.5 mg/ml) 500 ppm | >240 minutes | Fentanyl Citrate and | |||||||
| Concentration | Minimum | ||||||||
| Breakthrough | |||||||||
| Detection Time | |||||||||
| in Minutes | |||||||||
| 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm | >240 minutes | ||||||||
| 25) Paclitaxel (6.0 mg/ml) 6,000 ppm | >240 minutes | ||||||||
| 26) Rituximab (10.0 mg/ml) 10,000 ppm | >240 minutes | Fentanyl Citrate Injection | |||||||
| (100 mcg/2ml) | >240 | ||||||||
| 27) ThioTepa (10.0 mg/ml)10,000 ppm | 25.4 minutes | ||||||||
| 28) Trisenox (1.0 mg/ml) 1,000 ppm | >240 minutes | ||||||||
| 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm | >240 minutes | ||||||||
| The maximum testing time is 240 minutes. | |||||||||
| Warning: Do not use with Carmustine or ThioTepa. | |||||||||
| Material Use | Nitrile | Nitrile | Same | ||||||
| Color | Blue | Blue | Same | ||||||
| Sterility | Non-Sterile | Non-Sterile | Same | ||||||
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | ||||||
| Physical | |||||||||
| Properties | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | ||||||
| Freedom from | |||||||||
| Holes | |||||||||
| (D 5151) | AQL 2.5 Inspection Meets ASTM D5151-06 | AQL 2.5 Inspection Meets ASTM D5151-06 | Same | ||||||
| Residual Powder | |||||||||
| (D 6124) | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Same | ||||||
| Biocompatibility | Biocompatibility | ||||||||
| test – Primary | |||||||||
| Skin Irritation Test | |||||||||
| (ISO 10993-10) | Under the conditions of the study, not a | ||||||||
| primary skin irritant. | Under the conditions of the study, not a | ||||||||
| primary skin irritant. | Same |
10
| Biocompatibility
test – Dermal
Sensitization
Assay (ISO
10993-10) | Under conditions of the study, not a contact
sensitizer | Under conditions of the study, not a
contact sensitizer | Same |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|------|
| Biocompatibility
test – Acute | Under conditions of the ISO Acute Systemic
Injection test, not toxic | Under conditions of the ISO Acute
Systemic Injection test, not toxic | Same |
11
| systemic toxicity
Study (ISO
| 10993-11) | |||
|---|---|---|---|
| Resistance | |||
| against | |||
| Chemotherapy | |||
| Drugs Standards | |||
| Practice for | |||
| Assessment of | |||
| resistance of | |||
| Medical Glove to | |||
| Permeation by | |||
| Chemotherapy | |||
| drugs | |||
| ASTM D6978-5 | |||
| (2013) | Breakthrough greater than 240 min. | ||
| • Blenoxane (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 (10.0 mg/ml) | |||
| • Daunorubicin HCI (5.0 mg/ml) | |||
| • Docetaxel (10.0 mg/ml) | |||
| • Doxorubicin HCI (2.0 mg/ml) | |||
| • Epirubicin HCI (2.0 mg/ml) | |||
| • Etoposide (20.0 mg/ml) | |||
| • Fludarabine (25.0 mg/ml) | |||
| • Fluorouracil (50.0 mg/ml) | |||
| • Gemcitabine (38.0 mg/ml) | |||
| • Idarubicin HCI (1.0 mg/ml) | |||
| • Ifosfamide (50.0 mg/ml) | |||
| • Irinotecan (20.0 mg/ml) | |||
| • Mechlorethamine HCI (1.0 mg/ml) | |||
| • Melphalan (5.0 mg/ml) | |||
| • Methotrexate (25.0 mg/ml) | |||
| • Mitomycin C (0.5 mg/ml) | |||
| • Mitoxantrone (2.0 mg/ml) | |||
| • Paclitaxel (6.0 mg/ml) | |||
| • Rituximab (10.0 mg/ml) | |||
| • Trisenox (1.0 mg/ml) | |||
| • Vincristine Sulfate (1.0 mg/ml) |
Breakthrough at 73.7 min.
Carmustine (3.3 mg/ml)
Breakthrough at 25.4 min.
ThioTepa (10.0 mg/ml) | Breakthrough greater than 240 min.
• Cisplatin (1.0 mg/ml)
• Cyclophosphamide (20.0 mg/ml)
• Dacarbazine (10.0 mg/ml)
• Doxorubicin Hydrochloride (2.0
mg/ml)
• Etoposide (20.0 mg/ml)
• Fluorouracil (50.0 mg/ml)
• Methotrexate (25.0 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Paclitaxel (6.0 mg/ml)
• Vincristine Sulfate (1.0 mg/ml)
• Azacytidine (25.0 mg/m1)
• Carboplatin (10.0 mg/ml)
• Docetaxel (10 mg/ml)
• Epirubicin (2.0 mg/ml)
• Gemcitabine (38 mg/ml)
• Ifosfamide (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mitoxantrone (2.0 mg/ml)
• Oncovin (1.0 mg/ml)
• Oxaliplatin (5 mg/ml)
• Vinorelbine (10 mg/ml)
• Fentanyl Citrate (100 mcg/2ml)
Breakthrough at 21.4 min.
Carmustine (3.3 mg/ml)
Breakthrough at 67.2 min.
Thiotepa (10.0 mg/ml) | Similar |
IX. SUMMARY OF NONCLINICAL TESTING
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-10 | Demonstrate | ||
| accurate sizing | Dimensions | ||
| Overall Length (mm) = | |||
| 220 mm (sizes XS – S) and | |||
| 230 mm (sizes M - XL) | |||
| Width (± 10 mm) | |||
| Size XS = 70 mm Size S = 80 mm Size M = 95 mm | |||
| Size L = 110 mm Size XL = 120 mm | |||
| Thickness at Palm (mm) = 0.05 min. | |||
| Thickness at Finger Tip (mm) = 0.05 min. | Pass |
12
| ASTM D6319-10 | Demonstrate
tensile
conforming
properties | Before Aging (D 412):
Tensile Strength (MPa) = 14 min
Ultimate Elongation (%) = 500 min. | Pass |
|---------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------|
| | | After Aging (D 573) (70°C ± 2°C for 166 hrs ± 2 hrs.):
Tensile Strength (MPa) = 14 min
Ultimate Elongation (%) = 400 min | |
13
| ASTM D6319-10 | Demonstrate
glove integrity | Freedom from Holes (D 5151)
AQL 2.5 Inspection Level G-1 | Pass |
|--------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------|------|
| ASTM D6319-10 | Demonstrate
biocompatibility:
Residual powder | Residual Powder (D 6124)
≤ 2.0 mg/pc | Pass |
| Primary Skin
Irritation Test
ISO 10993-10 | Demonstrate
biocompatibility:
Skin irritation | Under the conditions of the study, Not a primary skin
irritant. | Pass |
| Dermal
Sensitization
Assay
ISO 10993-10 | Demonstrate
biocompatibility:
Skin sensitivity | Under the conditions of the study, Not a contact
sensitizer. | Pass |
| Acute Systemic
toxicity Study
ISO 10993-11 | Demonstrate
biocompatibility:
acute systemic
toxicity | Under conditions of the ISO Acute Systemic Injection
test, not toxic | Pass |
| Open box testing
AAMI 11737-1 | Demonstrate
acceptable open
box bioburden | Acceptable bioburden levels after 30 days open box | Pass |
X. SUMMARY OF CLINICAL TESTING
No clinical testing was performed.
XI. CONCLUSION
The conclusions drawn from the non-clinical testing demonstrates that the SHOWA® Blue Nitrile Powder Free Medical Examination Glove is as safe, as effective, and performs as well or better than the legally marketed device (K200581).