(346 days)
Not Found
No
The device is a disposable examination glove, and the description focuses on material properties, testing standards, and intended use as a barrier. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is a glove intended to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device is a glove, which serves as a barrier to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on material properties and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device's Intended Use: The intended use of these gloves is to be worn on an examiner's hand to prevent contamination between the patient and the examiner. This is a barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description clearly states they are "examination gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection."
- Testing Performed: The testing mentioned (ASTM D6978-05) is for the permeation resistance of the gloves to chemotherapy drugs and fentanyl, not for analyzing a patient specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic information, or any of the typical components or processes associated with IVD devices.
The device is a medical device, specifically a Class I medical device (based on the intended use and the predicate device K number), but it is not an IVD.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The gloves are powder free, ambidextrous, blue color, and beaded cuff.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hand
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)
Biocompatibility Testing
- Test: ISO 10993-10: Biological Evaluation of Medical Devices, Part 10-Test for Irritation and Skin Sensitization
- Purpose: Irritation Testing
- Results: Pass, Not a skin irritant
- Test: ISO 10993-10: Biological Evaluation of Medical Devices, Part 10-Test for Irritation and Skin Sensitization
- Purpose: Sensitization Testing
- Results: Pass, Not a skin sensitizer
- Test: ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Test for in vitro cytotoxicity
- Purpose: Cytotoxicity Testing
- Results: Fail, Exhibits severe cytotoxicity reactivity
- Test: ISO 10993-11: Biological Evaluation of Medical Devices, Part 11: Test for Systemic Toxicity
- Purpose: Systemic Toxicity Testing
- Results: Pass, Not toxic
Permeation Testing
- Study Type: Permeation Testing according to ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
- Key Results (Average Breakthrough Time):
- Carboplatin (Paraplatin), 10 mg/ml (10,000 ppm): > 240 min
- Carmustine (BCNU), 3.3 mg/ml (3,300 ppm): 46.6 min
- Cisplatin, 1.0 mg/ml (1,000 ppm): > 240 min
- Cloroquine 50 mg/ml (50,000 ppm): >2400 min
- Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm): > 240 min
- Dacarbazine, 10.0 mg/ml (10,000 ppm): > 240 min
- Docetaxel, 10 mg/ml (10,000 ppm): > 240 min
- Doxorubicin HCI, 2.0 mg/ml (2,000 ppm): > 240 min
- Etoposide, 20.0 mg/ml (20,000 ppm): > 240 min
- Fluorouracil, 50.0 mg/ml (50,000 ppm): > 240 min
- Ifosfamide, 50 mg/ml (50,000 ppm): > 240 min
- Methotrexate, 25 mg/ml (25,000 ppm): > 240 min
- Mitomycin C, 0.5 mg/ml (500 ppm): > 240 min
- Paclitaxel, 6.0 mg/ml (6,000 ppm): > 240 min
- ThioTepa, 10.0 mg/ml (10,000 ppm): 64.8 min
- Vincristine Sulfate, 1 mg/ml (1,000 ppm): > 240 min
- Fentanyl Citrate Injection 100 mcg/2ml (50 mcg/1ml): > 240 min
Clinical Test Conclusion:
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
May 23, 2022
PT. Shamrock Manufacturing Corpora Jeni Chuason Regulatory Affairs Manager JL. Raya Medan - Namorambe Ps IV Kab. Deli Serdang, North Sumatera 20356 Indonesia
Re: K211810
Trade/Device Name: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for used with Chemotherapy Drugs and Fentanyl) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: April 12, 2022 Received: April 13, 2022
Dear Jeni Chuason:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K211810
Device Name
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs and Fentanyl)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
| Chemotherapy Drug and Permeation | |
|---|---|
| The following chemicals have been tested with these gloves: | |
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
| Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) | > 240 min. |
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 46.6 min. |
| Chloroquine 50mg/ml (50,000ppm) | > 240 min |
| Cisplatin, 1.0 mg/ml (1,000ppm) | > 240 min |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0mg/ml (10,000ppm) | > 240 min |
| Docetaxel, 10mg/ml (10,000ppm) | > 240 min |
| Doxorubicin HCI, 2.0mg/ml (2,000ppm) | > 240 min |
| Etoposide, 20.0mg/ml (20,000ppm) | > 240 min |
| Fluorouracil, 50.0mg/ml (50,000ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| Thiotepa, 10.0mg/ml (10,000ppm) | 64.8 min |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Fentanyl Citrate Injection 100mcg/2ml (50mcg/1ml) | > 240 min |
Please note that the following drugs that have low permeation time are: Carmustine (BCNU), 3.3 mg/ml 46.6 min Thiotepa, 10.0mg/ml 64.8 min CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.
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.
3
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4
Jl. Raya Medan - Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara - Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007 Email: smc@shamrock.co.id
510(k) SUMMARY
Submitter:
Contact Person:
PT. SHAMROCK MANUFACTURING CORPORA
Address:
Email:
Jl. Raya Medan, Namorambe PS. IV Kab. Deli Serdang Sumatera Utara, Indonesia Tel. +62-61 703-0008 Fax. +62-61 703-0007 Imelda/Jeni Chuason smc@shamrock.co.id
Summary Preparation Date: April 12, 2022
Type of 510(k) Submission: Traditional
Proprietary/Trade Name:
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Common Name:
Powder Free Nitrile Examination Gloves, Specialty
Regulation Name:
Patient Examination Glove, Specialty (21 CFR 880.6250)
Classification Name:
Patient Exam Glove, Medical Gloves with Chemotherapy / Fentanyl Labeling Claims
LZA, LZC, OPJ, QDO Product Code:
Regulatory Class: Class I
Predicate Device:
YTY Industry (Manjung): Non-sterile, Powder-free Nitrile Examination Gloves (Cobalt Blue) tested for use with Chemotherapy Drugs (K111248)
Device Description:
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier
5
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).
Indications of Use:
A patient examination qlove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. These qloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
| Chemo Drugs tested: | Breakthrough Time
(Minutes) |
|------------------------------------------------------|--------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 46.6 |
| Chloroquine 50 mg/ml (50,000 ppm) | > 240 |
| Cisplatin 1 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide20 mg/ml (20,000 ppm) | > 240 |
| Doxorubicin HCL 2 mg/ml (2,000 ppm) | > 240 |
| Etoposide 20 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil 50 mg/ml (50,000 ppm) | > 240 |
| Paclitaxel 60 mg/ml (6,000 ppm) | > 240 |
| Thiotepa 10 mg/ml (10,000 ppm) | 64.8 |
| Carboplatin 10 mg/ml (10,000 ppm) | > 240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | > 240 |
| Docetaxel 10 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide 50 mg/ml (50,000 ppm) | > 240 |
| Methotrexate 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | > 240 |
| Vincristine Sulfate 1 mg/ml (1,000 ppm) | > 240 |
| Fentanyl Citrate Injection 100 mcg/2 ml (50 mcg/1mL) | > 240 |
6
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.
Comparison of Technological Characteristics
Comparison of Proposed Device to Predicate Device
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Shamrock Powder Free
Blue Nitrile Examination
Gloves (Tested for use
with Chemotherapy
Drugs and Fentanyl) | Non-Sterile, Powder-
Free Nitrile
Examination Gloves
(Cobalt) Tested for use
within chemotherapy
drugs | N/A |
| 510(K)
Reference | K211810 | K11248 | N/A |
| Product Owner | PT. Shamrock
Manufacturing Corpora | YTY Industry (Manjung)
SDN, BHD | N/A |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC | Similar |
| Indications for
Use | A patient Examination
Glove is a disposable
device intended for
medical purpose that is
worn on examiner's
hand to prevent
contamination between
patient and examiner.
These gloves were
tested for use with
Chemotherapy Drugs as
per ASTM D6978-05
(2019) Standard
Practice for Assessment
of Medical Gloves of
Permeation by
Chemotherapy Drugs | A patient examination
glove is a disposable
device intended for
medical purpose that is
worn on the examiner's
hand or fingers to
prevent contamination
between patient and
examiner. These gloves
were tested for use
with chemotherapy
drugs | Same |
| Regulation
number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Materials | Powder- Free Nitrile | Powder- Free Nitrile | Same |
| Color | Blue | Blue | Same |
| Sizes | x-small, small, medium,
large, x-large, xx-large | Medium, Large, Extra-
large | Similar |
| Dimensions
Length | Complies with:
ASTM D6319-19
220mm min | Complies with: ASTM
D6319-10
220mm min | Same |
| Dimensions
Width | Complies with:
ASTM D6319-19
70mm min | Complies with: ASTM
D6319-10
70mm min | Same |
| Dimensions
Thickness | Complies with:
ASTM D6319-19
Palm - 0.05mm min
Finger – 0.05mm min | Complies with: ASTM
D6319-10
Palm - 0.05mm min
Finger – 0.05mm min | Same |
| Physical
Properties | Complies with
ASTM D6319-19
Tensile Strength:
Before Aging ≥ 14 Mpa
(min)
After Aging ≥ 14 Mpa
(min) | Complies with:
ASTM D6319-10
Tensile Strength:
Before Aging ≥ 14 Mpa
(min)
After Aging ≥ 14 Mpa
(min) | Same |
| Physical
Properties | Elongation:
Before Aging 500%
After Aging 400% | Elongation:
Before Aging 500%
After Aging 400% | Same |
| Freedom from
Holes | Complies with:
ASTM D6319-19
ASTM D5151
AQL 2.5 | Complies with: ASTM
D6319-19
AQL 2.5 | Similar |
| Powder or
Powder-free | Powder-free | Powder-free | Same |
| Residue Powder | Complies with:
ASTM D6319-19 240
min | Carboplatin 10 mg/ml
(6,000 ppm) > 240 min | Same |
| | Dacarbazine (DTIC)
10.0 mg/ml (10,000
ppm) > 240 min | Dacarbazine (DTIC)
10.0 mg/ml (10,000
ppm) > 240 min | Same |
| | Docetaxel 10.0 mg/ml
(10,000 ppm) > 240
min | | Different |
| | Ifosfamide 50.0 mg/ml
(50,000 ppm) > 240
min | Ifosfamide 50.0 mg/ml
(50,000 ppm) > 240
min | Same |
| | Methotrexate 25.0
mg/ml (25,000 ppm)
240 min | Methotrexate 25.0
mg/ml (25,000 ppm)
240 min | Same |
| | Mitomycin C 0.5 mg/ml
(500 ppm) > 240 min | Mitomycin C 0.5 mg/ml
(500 ppm) > 240 min | Same |
| | Vincristine Sulfate 1
mg/ml (1,000 ppm)
240 min | | Different |
| | Carmustine 3.3 mg/ml
(3,300 ppm) 46.6 min | Carmustine 3.3 mg/ml
(3,300 ppm) 1.82 min | Same |
| | | | |
| | Chloroquine 50 mg/ml
(50,000 ppm) > 240 min | | Different |
| | Cisplatin 1 mg/ml
(1,000 ppm) > 240 min | Cisplatin 1 mg/ml
(1,000 ppm) > 240 min | Same |
| | Cyclophosphamide 20.0
mg/ml (20,000 ppm)
240 min | Cyclophosphamide 20.0
mg/ml (20,000 ppm)
240 min | Same |
| | Doxorubicin
Hydrochloride 2.0
mg/ml (2,000 ppm)
240 min | Doxorubicin
Hydrochloride 2.0
mg/ml (2,000 ppm)
240 min | Same |
| | Etoposide 20.0 mg/ml
(20,000 ppm)
240 min | Etoposide 20.0 mg/ml
(20,000 ppm)
240 min | Same |
| | Fluorouracil 50.0 mg/ml
(50,000 ppm)
240 min | Fluorouracil 50.0
mg/ml (50,000 ppm)
240 min | Same |
| | Paclitaxel 6.0 mg/ml
(6,000 ppm) > 240 min | Paclitaxel 6.0 mg/ml
(6,000 ppm) > 240 min | Same |
| | Thiotepa 10.0 mg/ml
(10,000 ppm) > 240
min | Thiotepa 10.0 mg/ml
(10,000 ppm) > 240
min | Same |
| Fentanyl
Testing | Fentanyl Citrate, 100
mcg/2ml > 240 min | | Different |
7
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
8
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
9
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
Summary of Non-Clinical Testing
Biocompatibility Testing
Below summary is the biocompatibility results for Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl).
10
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdanq, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007
Email: smc@shamrock.co.id
| Name of test /
citation | Purpose | Acceptance
Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------|-------------------------------------------------------|
| ISO 10993-10:
Biological Evaluation of
Medical Devices, Part
10-Test for Irritation
and Skin Sensitization | Irritation
Testing | Pass/Fail | Pass
Not a skin irritant |
| ISO 10993-10:
Biological Evaluation of
Medical Devices, Part
10-Test for Irritation
and Skin Sensitization | Sensitization
Testing | Pass/Fail | Pass
Not a skin
sensitizer |
| Name of test /
citation | Purpose | Acceptance
Criteria | Results |
| ISO 10993-5:
Biological Evaluation of
Medical Devices, Part
5: Test for in vitro
cytotoxicity | Cytotoxicity
Testing | Pass/Fail | Fail
Exhibits severe
cytotoxicity
reactivity |
| ISO 10993-11:
Biological Evaluation of
Medical Devices, Part
11: Test for Systemic
Toxicity | Systemic
Toxicity
Testing | Pass/Fail | Pass
Not toxic |
Permeation Testing
These gloves were tested to support the labeling claim: Tested for use with Chemotherapy Drugs and Fentanyl. The gloves were tested according to ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs and Fentanyl. Below table is the summary of the minimum breakthrough times.
Please note that the following drugs, Carmustine and Thiotepa have low permeation time of 46.6 minutes and 64.8 minutes (less than 240 minutes). Labeling will include caution statement in the presence of these chemotherapy druqs.
11
Jl. Raya Medan – Namorambe PS. IV Kab. Deli Serdang, Sumatera Utara – Indonesia Tel. (62-61) 7030008 Fax. (62-61) 7030007 Email: smc@shamrock.co.id
| Test Chemotherapy Drugs | Average
Breakthrough
Time |
|-----------------------------------------------------|---------------------------------|
| Carboplatin (Paraplatin), 10 mg/ml (10,000 ppm) | > 240 min |
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 46.6 min |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | > 240 min |
| Cloroquine 50 mg/ml (50,000 ppm) | >2400 min |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) | > 240 min |
| Docetaxel, 10 mg/ml (10,000 ppm) | > 240 min |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) | > 240 min |
| Etoposide, 20.0 mg/ml (20,000 ppm) | > 240 min |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25 mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| ThioTepa, 10.0 mg/ml (10,000 ppm) | 64.8 min |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Fentanyl Citrate Injection 100 mcg/2ml (50 mcg/1ml) | > 240 min |
Clinical Test Conclusion
Not applicable
Conclusion
The conclusions drawn from the non-clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.