(346 days)
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.
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 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).
The document describes the acceptance criteria and performance of "Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Biocompatibility | |||
| ISO 10993-10: Irritation | Irritation Testing | Pass/Fail | Pass (Not a skin irritant) |
| ISO 10993-10: Sensitization | Sensitization Testing | Pass/Fail | Pass (Not a skin sensitizer) |
| ISO 10993-5: Cytotoxicity | Cytotoxicity Testing | Pass/Fail | Fail (Exhibits severe cytotoxicity reactivity) - Note: This is acknowledged and addressed in the Summary of Non-Clinical Testing. |
| ISO 10993-11: Systemic Toxicity | Systemic Toxicity Testing | Pass/Fail | Pass (Not toxic) |
| Permeation Testing (ASTM D6978-05(2019)) | Assessment of resistance to permeation by chemotherapy drugs and Fentanyl | Minimum breakthrough times | See detailed table below for each chemical. The general criterion is to report breakthrough time. |
Detailed Permeation Testing Results:
| Chemotherapy Drug and Concentration | Reported Breakthrough Detection Time (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 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of gloves tested for each permeation or biocompatibility test. The document refers to compliance with standards like ASTM D6978-05(2019) and ISO 10993, which typically specify sample sizes for such tests.
- Data Provenance: The testing was performed for the submitter, PT. Shamrock Manufacturing Corpora, based in North Sumatera, Indonesia. The tests are "non-clinical tests," implying laboratory-based testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable as the document describes non-clinical testing of a medical device (gloves) for physical properties and chemical resistance. There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation. The ground truth for these tests is defined by the standardized methodologies of ASTM and ISO.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the document describes non-clinical testing of a medical device (gloves). Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device is medical examination gloves, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. The device is medical examination gloves, not an algorithm or software. The tests performed are laboratory-based assessments of material properties and chemical resistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by standardized test methods and material science principles. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards. For permeation, it's the measured breakthrough time according to ASTM D6978-05(2019). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of device testing for medical gloves. This refers to a dataset used to train AI/machine learning models, which is irrelevant for this device.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #8.
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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.
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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
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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.
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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
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
|---|---|---|---|
| Product Name | Shamrock Powder FreeBlue Nitrile ExaminationGloves (Tested for usewith ChemotherapyDrugs and Fentanyl) | Non-Sterile, Powder-Free NitrileExamination Gloves(Cobalt) Tested for usewithin chemotherapydrugs | N/A |
| 510(K)Reference | K211810 | K11248 | N/A |
| Product Owner | PT. ShamrockManufacturing Corpora | YTY Industry (Manjung)SDN, BHD | N/A |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC | Similar |
| Indications forUse | A patient ExaminationGlove is a disposabledevice intended formedical purpose that isworn on examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withChemotherapy Drugs asper ASTM D6978-05(2019) StandardPractice for Assessmentof Medical Gloves ofPermeation byChemotherapy Drugs | A patient examinationglove is a disposabledevice intended formedical purpose that isworn on the examiner'shand or fingers toprevent contaminationbetween patient andexaminer. These gloveswere tested for usewith chemotherapydrugs | Same |
| Regulationnumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
| 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 |
| DimensionsLength | Complies with:ASTM D6319-19220mm min | Complies with: ASTMD6319-10220mm min | Same |
| DimensionsWidth | Complies with:ASTM D6319-1970mm min | Complies with: ASTMD6319-1070mm min | Same |
| DimensionsThickness | Complies with:ASTM D6319-19Palm - 0.05mm minFinger – 0.05mm min | Complies with: ASTMD6319-10Palm - 0.05mm minFinger – 0.05mm min | Same |
| PhysicalProperties | Complies withASTM D6319-19Tensile Strength:Before Aging ≥ 14 Mpa(min)After Aging ≥ 14 Mpa(min) | Complies with:ASTM D6319-10Tensile Strength:Before Aging ≥ 14 Mpa(min)After Aging ≥ 14 Mpa(min) | Same |
| PhysicalProperties | Elongation:Before Aging 500%After Aging 400% | Elongation:Before Aging 500%After Aging 400% | Same |
| Freedom fromHoles | Complies with:ASTM D6319-19ASTM D5151AQL 2.5 | Complies with: ASTMD6319-19AQL 2.5 | Similar |
| Powder orPowder-free | Powder-free | Powder-free | Same |
| Residue Powder | Complies with:ASTM D6319-19 < 2mg per glove | Complies with: ASTMD6319-19 < 2 mg perglove | same |
| ContactDurations | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| Biocompatibility | ISO 10993-10:Not a skin irritantNot a skin sensitizerISO 10993-5:Exhibit severecytotoxicity reactivityISO 10993-11:Not Toxic | ISO 10993-10:Not a skin irritantNot a skin sensitizerISO 10993-5:Not availableISO 10993-11:Not available | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| TestedChemotherapyDrugs | Carboplatin 10 mg/ml(10,000 ppm) > 240min | Carboplatin 10 mg/ml(6,000 ppm) > 240 min | Same |
| Dacarbazine (DTIC)10.0 mg/ml (10,000ppm) > 240 min | Dacarbazine (DTIC)10.0 mg/ml (10,000ppm) > 240 min | Same | |
| Docetaxel 10.0 mg/ml(10,000 ppm) > 240min | Different | ||
| Ifosfamide 50.0 mg/ml(50,000 ppm) > 240min | Ifosfamide 50.0 mg/ml(50,000 ppm) > 240min | Same | |
| Methotrexate 25.0mg/ml (25,000 ppm)> 240 min | Methotrexate 25.0mg/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 1mg/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 20.0mg/ml (20,000 ppm)> 240 min | Cyclophosphamide 20.0mg/ml (20,000 ppm)> 240 min | Same | |
| DoxorubicinHydrochloride 2.0mg/ml (2,000 ppm)> 240 min | DoxorubicinHydrochloride 2.0mg/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 50.0mg/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) > 240min | Thiotepa 10.0 mg/ml(10,000 ppm) > 240min | Same | |
| FentanylTesting | Fentanyl Citrate, 100mcg/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 | AcceptanceCriteria | Results |
|---|---|---|---|
| ISO 10993-10:Biological Evaluation ofMedical Devices, Part10-Test for Irritationand Skin Sensitization | IrritationTesting | Pass/Fail | PassNot a skin irritant |
| ISO 10993-10:Biological Evaluation ofMedical Devices, Part10-Test for Irritationand Skin Sensitization | SensitizationTesting | Pass/Fail | PassNot a skinsensitizer |
| Name of test /citation | Purpose | AcceptanceCriteria | Results |
| ISO 10993-5:Biological Evaluation ofMedical Devices, Part5: Test for in vitrocytotoxicity | CytotoxicityTesting | Pass/Fail | FailExhibits severecytotoxicityreactivity |
| ISO 10993-11:Biological Evaluation ofMedical Devices, Part11: Test for SystemicToxicity | SystemicToxicityTesting | Pass/Fail | PassNot 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 | AverageBreakthroughTime |
|---|---|
| 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.
§ 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.