(173 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).
The subject device in this 510(k) Notification is Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate, Powder Free & Non sterile Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves & ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The available sizes of the subject devices are Small, Medium, Large, X-Large.
The provided text describes the acceptance criteria and the study that proves the device (Iconic Blue Nitrile Glove) meets them. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance (Iconic Blue Nitrile Glove) | Remarks |
|---|---|---|---|
| Physical Properties (ASTM D6319-19) | |||
| Freedom from hole - ASTM D5151-19 | AQL 2.5 | Pass | Pass |
| Dimensions (Width, Length, Thickness) | Overall Length: Min 230mm; Width (±10mm): S-80, M-95, L-110, XL-120; Thickness (Palm & Fingertip): Min 0.05 mm | Overall Length: 234-244mm; Width: 84.69-119.07mm; Palm Thickness: 0.09-0.1mm; Fingertip Thickness: 0.11-0.12mm | Pass |
| Tensile Strength (Before Aging) | 14 MPa, min. | 20.07-21.82 MPa | Pass |
| Ultimate Elongation (Before Aging) | 500 % min | 836.57-900.24 % | Pass |
| Tensile Strength (After Accelerated Aging) | 14 MPa, min. | 20.35-23.54 MPa | Pass |
| Ultimate Elongation (After Accelerated Aging) | 400 % min | 813.34-878.09 % | Pass |
| Powder-free Residue - ASTM D6124-06 | < 2.0 mg per glove | 0.26-0.6 mg per glove | Pass |
| Biocompatibility (ISO 10993 Series) | |||
| Invitro cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-Cytotoxic to L929 cells | Pass (Note: Predicate device showed potential toxicity, but the subject device is non-cytotoxic, thus not affecting safety/effectiveness) |
| Irritation and Skin Sensitization (ISO 10993-10) | Non-Sensitizing, non-Irritating | Non-Sensitizing, non-Irritating | Pass |
| Acute systemic toxicity (ISO 10993-11) | Not induce acute systemic toxicity | Not induce acute systemic toxicity | Pass |
| Chemotherapy Drugs Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time | ||
| Carboplatin, 10 mg/ml | >240 min. | >240 min. | Pass |
| Carmustine, 3.3 mg/ml | N/A (Predicate: 11.1 min) | 26.6 min (27.5, 26.6, 26.8) | Different from predicate (better performance for subject device), but device labeled with warning for low permeation time. |
| Cisplatin, 1 mg/ml | >240 min. | >240 min. | Pass |
| Cyclophosphamide, 20 mg/ml | >240 min. | >240 min. | Pass |
| Dacarbazine, 10 mg/ml | >240 min. | >240 min. | Pass |
| Doxorubicin HCI, 2 mg/ml | >240 min. | >240 min. | Pass |
| Etoposide, 20 mg/ml | >240 min. | >240 min. | Pass |
| Fluorouracil, 50 mg/ml | >240 min. | >240 min. | Pass |
| Methotrexate, 25 mg/ml | >240 min. | >240 min. | Pass |
| Mitomycin C, 0.5 mg/ml | >240 min. | >240 min. | Pass |
| Mitoxantrone, 2 mg/ml | >240 min. | >240 min. | Pass |
| Oxaliplatin, 5 mg/ml | >240 min. | >240 min. | Pass |
| Paclitaxel, 6 mg/ml | >240 min. | >240 min. | Pass |
| Thiotepa, 10 mg/ml | N/A (Predicate: 21.6 min) | 56.0 min (58.4, 56.5, 56.0) | Different from predicate (better performance for subject device), but device labeled with warning for low permeation time. |
| Vincristine Sulfate, 1 mg/ml | >240 min. | >240 min. | Pass |
| Opioid Drugs Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time | ||
| Fentanyl Citrate Injection, 100mcg/2ml | >240 min. | >240 min. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each test conducted but references standards like ASTM D6319-19 for physical properties, which would imply a specific sampling plan within that standard (e.g., AQL 2.5, AQL 4.0 inspection level S-2). For chemotherapy drug permeation, three specimens were tested for each drug, as indicated by "Minimum Breakthrough Detection Time (Specimen 1,2,3)".
The data provenance is not explicitly stated in terms of country of origin. The studies are non-clinical (laboratory tests) and are retrospective in the sense that they were performed to demonstrate compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The evaluations are based on standardized laboratory tests (e.g., ASTM, ISO standards) rather than expert interpretation of medical images or patient data. The "ground truth" is determined by measurements against predefined quantitative criteria and methodologies outlined in these standards.
4. Adjudication method for the test set
This section is not applicable as the tests are objective, quantitative measurements against established standards. There is no subjective interpretation requiring expert adjudication.
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 section is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool or an imaging system. Therefore, MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through material and chemical resistance tests.
7. The type of ground truth used
The ground truth used for these studies is based on standardized, objective measures and methodologies defined by established industry and regulatory standards, including:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application (for physical properties like dimensions, tensile strength, elongation).
- ASTM D5151-19: Standard for Freedom from hole (pinholes).
- ASTM D6124-06: Standard for Residual Powder.
- ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical breakthrough times).
- ISO 10993-5 (Biological evaluation of medical devices - Part 5): Tests for in vitro cytotoxicity.
- ISO 10993-10 (Biological evaluation of medical devices - Part 10): Tests for irritation and skin sensitization.
- ISO 10993-11 (Biological evaluation of medical devices - Part 11): Tests for systemic toxicity.
The "ground truth" is the result of these specific test procedures and direct measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This section is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the context of AI or algorithms.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above (not an AI/ML device).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 11, 2023
Iconic medicare sdn bhd % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main road, Anna Nagar West Chennai, Tamil Nadu 600040 India
Re: K222181
Trade/Device Name: Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: December 22, 2022 Received: December 28, 2022
Dear A.C. Thirumaran:
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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222181
Device Name
Iconic Blue Nitrile Glove- Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).
The following chemicals have been tested with these gloves.
| S.No | Chemotherapy Drugs | Concentration | Minimum BreakthroughDetection Time(Specimen 1,2,3)(Minutes) |
|---|---|---|---|
| 1 | Carboplatin, | 10 mg/ml (10,000 ppm) | >240 min. |
| 2 | Carmustine, | 3.3 mg/ml (3,300 ppm) | 26.6 (27.5,26.6,26.8) |
| 3 | Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| 4 | Cyclophosphamide, | 20 mg/ml (20,000 ppm) | >240 min. |
| 5 | Dacarbazine, | 10 mg/ml (10,000 ppm) | >240 min. |
| 6 | Doxorubicin HCI, | 2 mg/ml (2,000 ppm) | >240 min. |
| 7 | Etoposide, | 20 mg/ml (20,000 ppm) | >240 min. |
| 8 | Fluorouracil, | 50 mg/ml (50,000 ppm) | >240 min. |
| 9 | Methotrexate, | 25 mg/ml (25,000 ppm) | >240 min. |
| 10 | Mitomycin C, | 0.5 mg/ml (500 ppm) | >240 min. |
| 11 | Mitoxantrone, | 2 mg/ml (2,000 ppm) | >240 min. |
| 12 | Oxaliplatin, | 5 mg/ml (5,000 ppm) | >240 min. |
| 13 | Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| 14 | Thiotepa, | 10 mg/ml (10,000 ppm) | 56.0 (58.4,56.5,56.0) |
| 15 | Vincristine Sulfate, | 1 mg/ml (1,000 ppm) | >240 min. |
| S.No | Opiod Drugs | Concentration | Minimum BreakthroughDetection Time(Specimen 1,2,3)(Minutes) |
| 16 | Fentanyl Citrate Injection | 100mcg/2mL | >240 min. |
| Please note that the following drugs have low permeation times:Carmustine: 26.6 minutesThiotepa: 56.0 minutesWarning - Please do not use with Carmustine and 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.
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Image /page/4/Picture/0 description: The image shows the word "iconic" in gray font. To the right of the word, there are four vertical bars in red, orange, yellow, and green. The bars are slightly offset from each other, creating a layered effect. The overall design is modern and minimalist.
510(K) Summary - K222181
ICONIC BLUE NITRILE GLOVE
Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Preparation Date: January 11, 2023
1. Submitter:
Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian Batu Kawan, 14110 Bandar Cassia, Pulau Pinang. Email: cctan(@iconic.com.my
2. Name of the Device
Trade Name / Proprietary Name: Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate. Device Common Name: Non-Powdered Patient Examination Glove. Device Classification Name: Polymer Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA, LZC, QDO, OPJ 510k Number: K222181
3. Official Correspondent
Mr.A.C.Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main Road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com
4. Identification of the Legally Marketed Predicate Device:
Predicate Device: Better Care Plastic Technology Co., Ltd. 510k Number: - K221269 Device Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Device Classification Name: Polymer Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA, LZC, QDO
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Image /page/5/Picture/0 description: The image shows the logo for Iconic. The logo is a wordmark with the word "iconic" in a sans-serif font. To the right of the word "iconic" are four vertical bars of different colors: red, orange, yellow, and green. The bars are slightly offset from each other, creating a sense of depth.
5. Device Description
The subject device in this 510(k) Notification is Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate, Powder Free & Non sterile Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves & ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The available sizes of the subject devices are Small, Medium, Large, X-Large.
6. Intended use of the Device
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).
The following chemicals have been tested with these gloves.
| S.No | Chemotherapy Drugs | Concentration | Minimum BreakthroughDetection Time(Specimen 1,2,3)(Minutes) |
|---|---|---|---|
| 1 | Carboplatin, | 10 mg/ml (10,000 ppm) | >240 min. |
| 2 | Carmustine, | 3.3 mg/ml (3,300 ppm) | 26.6 (27.5,26.6,26.8) |
| 3 | Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| 4 | Cyclophosphamide, | 20 mg/ml (20,000 ppm) | >240 min. |
| 5 | Dacarbazine, | 10 mg/ml (10,000 ppm) | >240 min. |
| 6 | Doxorubicin HCI, | 2 mg/ml (2,000 ppm) | >240 min. |
| 7 | Etoposide, | 20 mg/ml (20,000 ppm) | >240 min. |
| 8 | Fluorouracil, | 50 mg/ml (50,000 ppm) | >240 min. |
| 9 | Methotrexate, | 25 mg/ml (25,000 ppm) | >240 min. |
| 10 | Mitomycin C, | 0.5 mg/ml (500 ppm) | >240 min. |
| 11 | Mitoxantrone, | 2 mg/ml (2,000 ppm) | >240 min. |
| 12 | Oxaliplatin, | 5 mg/ml (5,000 ppm) | >240 min. |
| 13 | Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| 14 | Thiotepa, | 10 mg/ml (10,000 ppm) | 56.0 (58.4,56.5,56.0) |
| 15 | Vincristine Sulfate, | 1 mg/ml (1,000 ppm) | >240 min. |
| S.No | Opiod Drugs | Concentration | Minimum BreakthroughDetection Time(Specimen 1,2,3)(Minutes) |
| 16 | Fentanyl Citrate Injection, | 100mcg/2mL | >240 min. |
Please note that the following drugs have low permeation times: Carmustine: 26.6 minutes Thiotepa: 56.0 minutes * Warning - Please do not use with Carmustine and Thiotepa
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Image /page/6/Picture/0 description: The image shows the word "iconic" in gray font. To the right of the word, there are four vertical lines in red, orange, yellow, and green. The lines are slightly slanted to the right. The word "iconic" is written in lowercase letters.
7. Technological characteristics Comparison for the proposed and predicate devices
| Characteristics | Acceptance Criteria | Subject device: K222181 Iconic BlueNitrile Glove- Blue Tested for Use withChemotherapy Drugs and FentanylCitrate (Small, Medium, Large, X-Large) | Predicate Device: K221269 PowderFree Nitrile Examination Gloves(Blue), Tested for Use withChemotherapy Drugs and FentanylCitrate | Remarks |
|---|---|---|---|---|
| Product Code | NA | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Different |
| Intended use | A powder free patientexamination glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. The deviceis for over- the- counter use. | A patient examination glove is adisposable device intended for medicalpurpose that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner. Thesegloves were tested for use withChemotherapy Drugs and FentanylCitrate as per ASTM D6978-05 (2019).Please note that the following drugs havelow permeation times: Carmustine: 26.6minutes, Thiotepa: 56.0 minutesWarning - Please do not use withCarmustine and Thiotepa | The glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination between patientand examiner. Gloves have been testedfor use with chemotherapy drugs andFentanyl Citrate using ASTM D6978-05(2019).Please note that the following drugshave extremely low permeation times:Carmustine: 11.1 minutes, Thiotepa:21.6 minutes. Warning: Do not usewith Carmustine and Thiotepa. | same |
| Material used | Nitrile compound | Nitrile compound | Nitrile compound | same |
| Colour | N/A | Blue | Blue | same |
| Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same |
| Single use | Single use | Single use | Single use | same |
| Dimensions | Overall Length (mm) Min 230mmWidth (±10mm)Small - 80Medium- 95Large-110X-large-120 | Overall Length (mm) Min 230mmSmall - 80Medium- 95Large-110X-large-120 | Overall Length (mm) Min 230mmSmall - 80Medium- 95Large-110X-large-120 | same |
| Thickness at Palm (mm) Min; 0.05mm | Thickness at Palm (mm) Min; 0.05 mm | Thickness at Palm (mm) Min; 0.05 mm | same | |
| Thickness at Finger Tip (mm) Min0.05 mm | Thickness at Finger Tip (mm) Min 0.05mm | Thickness at Finger Tip (mm) Min0.05 mm | same | |
| a.Before Aging | ||||
| Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | same | |
| PhysicalProperties | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | same |
| Tensile Strength=14 MPa, min. | b. After Accelerated AgingTensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | same | |
| Ultimate Elongation= 400 % min | Ultimate Elongation= 400 % min | Ultimate Elongation= 400 % min | same | |
| Freedom frompinholes ASTMD5151 | AQL 2.5 Inspection LevelG-1 | AQL 2.5 | AQL 2.5 | same |
| Residual PowderASTM D6124-06 | < 2.0 mg/pc | < 2.0 mg/pc | < 2.0 mg/pc | same |
| ISO 10993-10:2010 Biologicalevaluation of medical devices -Part 10: Tests for irritation and skinsensitization | Under the conditions of this study, the testarticle was a non- sensitizer. | Under the conditions of this study, thetest article was a non- sensitizer. | same | |
| ISO 10993-10:2010 Biologicalevaluation of medical devices -Part 10: Tests for irritation and skinsensitization | Under the conditions of this study, the testarticle was a non-Irritant | Under the conditions of this study, thetest article was a non-Irritant | same | |
| ISO 10993-5:2009 Biologicalevaluation of medical devices -Part 5: Tests for in vitrocytotoxicity | Non-Cytotoxic to L929 cells | Under the conditions of this study,the test article extract showedpotential toxicity to L929 cells | Different | |
| ISO 10993-11:2017 Biologicalevaluation of medical devices -Part 11 · Tests for systemic toxicity | Not induce acute systemic toxicity | Under the conditions of this study,there was no evidence of acutesystemic toxicity | same | |
| TESTCHEMOTHERAPYDRUGS &Concentration | Subject device: Iconic Blue NitrileGlove- Blue Tested for Use withChemotherapy Drugs and FentanylCitrate (Small, Medium, Large, X-Large) | Predicate Device K221269Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs andFentanyl Citrate | Remarks | |
| MINIMUM BREAKTHROUGH DETECTION TIME(Minutes) | ||||
| Carboplatin, 10 mg/ml(10,000 ppm) | >240 min. | >240 min. | same | |
| Carmustine, 3.3 mg/ml(3,300 ppm) | 26.6 | 11.1 | Different | |
| Cisplatin, 1 mg/ml (1,000 | >240 min. | >240 min. | same | |
| ppm)Cvclophosphamide. | >240 min. | >240 min. | same | |
| 20mg/ml (20,000 ppm)Dacarbazine, 10 mg/ml | >240 min. | >240 min. | same | |
| (10,000 ppm)Doxorubicin HCI, 2mg/ml | >240 min. | >240 min. | same | |
| (2,000 ppm)Etoposide, 20 | >240 min. | >240 min. | same | |
| mg/ml(20,000 ppm)Fluorouracil, 50 | ||||
| mg/ml(50,000 ppm)Methotrexate, 25 | >240 min. | >240 min. | same | |
| mg/ml(25,000 ppm)Mitomycin C, 0.5 mg/ml | >240 min. | >240 min. | same | |
| (500 ppm) | >240 min. | >240 min. | same | |
| Mitoxantrone, 2mg/ml(2,000 ppm) | >240 min. | >240 min. | same | |
| Oxaliplatin, 5 mg/ml(5,000ppm) | >240 min. | >240 min. | same | |
| Paclitaxel, 6 mg/ml (6,000ppm) | >240 min. | >240 min. | same | |
| Thiotepa, 10 mg/ml(10,000 ppm) | રેણ | 21.6 | Different | |
| D6978-05 (Reapproved 2019) | Vincristine Sulfate, 1 mg/ml(1,000 ppm) | >240 min. | >240 min. | same |
| Standard Practice forAssessment of Resistance of | Busulfan 6mg/ml (6,000ppm) | Not Tested | >240 min | Different |
| Medical Gloves to Permeationby Chemotherapy Drugs | Chloroquine 50mg/ml(50,000ppm) | Not Tested | >240 min | Different |
| Cyclosporin 100 mg/ml | Not Tested | >240 min | Different | |
| (100,000 ppm)Cytarabine HCL, 100 | Not Tested | >240 min | Different | |
| mg/ml (100,000 ppm)Daunorubicin HCL, 5 | Not Tested | >240 min | Different | |
| mg/ml (5,000 ppm)Docetaxel, 10 mg/ml | Not Tested | >240 min | Different | |
| (10,000 ppm)Epirubicin HCL, 2 mg/ml | Not Tested | >240 min | Different | |
| (2,000 ppm)Fludarabine, 25 mg/ml | Not Tested | >240 min | Different | |
| (25,000 ppm)Gemcitabine, 38mg/ml | Not Tested | |||
| (38,000ppm)Idarubicin HCL, 1mg/ml | Not Tested | >240 min | Different | |
| (1,000ppm)Ifosfamide, 50mg/ml | Not Tested | >240 min | Different | |
| (50,000ppm) | >240 min | Different | ||
| Irinotecan, 20mg/ml(20,000ppm) | Not Tested | >240 min | Different | |
| Mechlorethamine HCI,1mg/ml (1,000ppm) | Not Tested | >240 min | Different | |
| Melphalan, 5mg/ml(5,000ppm) | Not Tested | >240 min | Different | |
| Paraplatin, 10mg/ml(10,000ppm) | Not Tested | >240 min | Different | |
| Retrovir, 10mg/ml(10.000ppm) | Not Tested | >240 min | Different | |
| Rituximab, 10mg/ml(10,000ppm) | Not Tested | >240 min | Different | |
| Topotecan, 1mg/ml | Not Tested | >240 min | Different | |
| (1,000ppm)Trisenox, 1mg/ml | Not Tested | >240 min | Different | |
| (1,000ppm)Velcade, 1mg/ml | Not Tested | >240 min | Different | |
| OPIOD DRUGS | 1,000ppm)TEST OPIOD DRUGS | MINIMUM BREAKTHROUGHDETECTION TIME(Specimen1/2/3) (Minutes) | AVERAGE STEADY STATEPERM. RATE(Specimen1/2/3) (ug/cm-/minute) | Remarks |
| Fentanyl Citrate Injection,100mcg/2mL | >240 min | >240 min | same |
Note: The difference between the subject device and product code and ISO 1093-5 Biological evaluation of medical device – part 5: Test for in vitro cytotoxicity test results. The subject device meets the requirements of ASTM 6319 and non-eytoloxic to L929 cells, hence the subject device do not affect the safety and effectiveness of the device.
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Image /page/7/Picture/0 description: The image shows the logo for Iconic. The word "iconic" is written in gray lowercase letters. To the right of the word is a design of four vertical bars in the colors red, orange, yellow, and green.
Note: The assessment of resistance of Subject medical glove to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact are tested include in emotherapy drugs as stated inthe ASTM D6978. Both the devices i labelled with the warnings and tested chemotherapy drugs list.
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Image /page/8/Picture/0 description: The image shows the logo for Iconic. The logo consists of the word "iconic" in gray, with the "i", "c", "o", and "n" connected. To the right of the word is a series of four vertical bars in red, orange, yellow, and green. The bars are slightly offset from each other, creating a sense of depth.
8. Summary of non-clinical testing results
Iconic Blue Nitrile Glove was tested and found in conformance with the following standards:
| ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application |
|---|---|
| ASTM D6978-05 | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by |
| (Reapproved 2019) | Chemotherapy Drugs. |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation on medical device Part 10: Test for irritation and Skin Irritation |
| ISO 10993-11 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity. |
| Test Methodology | Purpose | Acceptance Criteria | Average Results | Final status | |||
|---|---|---|---|---|---|---|---|
| Size | - | Small | Medium | Large | X Large | - | |
| Sterility | - | Non sterile | Non sterile | Non sterile | Non sterile | - | |
| Freedom fromhole - ASTMD5151-19 | AQL 2.5 | Pass | Pass | Pass | Pass | Pass | |
| Overall Length (mm)Min 230mm. | 234 | 234.61 | 240 | 244 | Pass | ||
| Dimensions –width, Length,ThicknessAQL 4.0Inspection levelS-2 | Width (±10mm)Small - 80Medium- 95Large-110X- large-120 | 84.69 | 96.15 | 111.7 | 119.07 | Pass | |
| ASTM D6319- 19 | Thickness atPalm & fingertipMin: 0.05 mmAQL 4.0Inspection levelS-2 | Palm | 0.09 | 0.09 | 0.1 | 0.1 | Pass |
| Fingertip | 0.12 | 0.11 | 0.12 | 0.11 | Pass | ||
| a. Before Aging | |||||||
| Physicalproperties beforeaging, afteraccelerated agingAQL 4.0Inspection levelS-2 | Tensile Strength=14MPa, min. | 21.12 | 20.07 | 20.53 | 21.82 | Pass | |
| Ultimate Elongation=500 % Min | 900.24 | 836.57 | 839.47 | 841.89 | Pass | ||
| b. After Accelerated Aging | |||||||
| Tensile Strength=14MPa, min. | 23.54 | 20.35 | 21.96 | 21.2 | Pass | ||
| Ultimate Elongation=400 % Min | 878.09 | 813.34 | 851.65 | 815.63 | Pass | ||
| Powder-freeResidue exceedsmaximum limit -ASTM D6124-06 | < 2.0 mg per glove | 0.26 | 0.42 | 0.34 | 0.6 | Pass | |
| ISO 10993-5 | Test for Invitrocytotoxicity | Non-Cytotoxic | Pass | ||||
| ISO 10993-10 | Test for irritationand SkinSensitization | Non-Sensitizingnon-Irritating | Pass | ||||
| ISO 10993-11 | Tests for acutesystemic toxicity | Not induce acutesystemic toxicity | Pass |
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Image /page/9/Picture/6 description: The image shows the logo for Iconic. The word "iconic" is written in gray, lowercase letters. To the right of the word, there are four vertical lines in different colors: red, orange, yellow, and green. The lines are slightly offset from each other, creating a sense of depth.
| Teststandard | S.No | TEST CHEMOTHERAPY DRUGS | MINIMUMBREAKTHROUGHDETECTION TIME(Specimen1/2/3) (Minutes) | AVERAGE STEADYSTATE PERM. RATE(Specimen1/2/3)(µg/cm2/minute) | OtherOBSERVATIONS |
|---|---|---|---|---|---|
| ASTM D6978-05(2019) | 1 | Carboplatin, 10mg/ml (10,000 ppm) | >240 min. | N/A | Slight swelling andno degradation |
| 2 | Carmustine, 3.3mg/ml (3,300 ppm) | 26.6 (27.5,26.6,26.8) | 0.5(0.4,0.6,0.5) | Slight swelling andno degradation | |
| 3 | Cisplatin, 1 mg/ml(1,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 4 | Cyclophosphamide, 20 mg/ml (20,000ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 5 | Dacarbazine, 10 mg/ml (10,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 6 | Doxorubicin HCI, 2mg/ml (2,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 7 | Etoposide, 20 mg/ml(20,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 8 | Fluorouracil, 50mg/ml (50,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 9 | Methotrexate, 25mg/ml (25,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 10 | Mitomycin C, 0.5mg/ml (500 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 11 | Mitoxantrone, 2mg/ml (2,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 12 | Oxaliplatin, 5 mg/ml(5,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 13 | Paclitaxel, 6 mg/ml(6,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 14 | Thiotepa, 10 mg/ml(10,000 ppm) | 56.0 (58.4,56.5,56.0) | 1.1(1.1,1.2,1.1) | Slight swelling andno degradation | |
| 15 | Vincristine Sulfate, 1mg/ml (1,000 ppm) | >240 min. | N/A | Slight swelling andno degradation | |
| 16 | TEST OPIOD DRUGS | MINIMUMBREAKTHROUGHDETECTION TIME(Specimen1/2/3) (Minutes) | AVERAGE STEADYSTATEPERM. RATE(Specimen1/2/3)(µg/cm2/minute) | OtherOBSERVATIONS | |
| Fentanyl Citrate Injection, 100mcg/2mL | >240 min | N/A | Slight swelling andno degradation |
9. Summary of clinical Performance data
Not applicable - Clinical data was not used to assess performance of the subject device.
10. Conclusion
The Conclusions drawn from the non-Clinical tests demonstrate that the subject device- Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K221269.
§ 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.