(173 days)
Not Found
No
The device is a standard examination glove and the summary does not mention any AI or ML capabilities.
No.
The device is a patient examination glove, intended to prevent contamination, not to provide therapy.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove made from Nitrile compound, clearly described as a tangible hardware product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device for personal protection and infection control.
- Device Description: The description reinforces this by identifying it as a "patient examination glove" made from Nitrile compound.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
- Testing: The testing performed (physical properties, freedom from holes, biocompatibility, chemotherapy drug and fentanyl permeation) is consistent with the evaluation of a barrier device, not an IVD.
In summary, the device's function is to provide a physical barrier, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Carmustine, 3.3 mg/ml (3,300 ppm), Minimum Breakthrough Detection Time: 26.6 (27.5,26.6,26.8) Minutes
Thiotepa, 10 mg/ml (10,000 ppm), Minimum Breakthrough Detection Time: 56.0 (58.4,56.5,56.0) Minutes
Warning - Please do not use with Carmustine and Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by 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.
Key results:
- Freedom from hole - ASTM D5151-19: AQL 2.5, Pass for all sizes (Small, Medium, Large, X Large).
- Dimensions – width, Length, Thickness AQL 4.0 Inspection level S-2:
- Overall Length (mm) Min 230mm: Small - 234, Medium - 234.61, Large - 240, X Large - 244 (All Pass).
- Width (±10mm): Small - 84.69, Medium - 96.15, Large - 111.7, X Large - 119.07 (All Pass).
- Thickness at Palm & fingertip Min: 0.05 mm: Palm - 0.09 (Small, Medium), 0.1 (Large, X Large); Fingertip - 0.12 (Small, Large), 0.11 (Medium, X Large) (All Pass).
- Physical properties (before aging and after accelerated aging) AQL 4.0 Inspection level S-2:
- Before Aging: Tensile Strength=14 MPa, min. - 21.12 (Small), 20.07 (Medium), 20.53 (Large), 21.82 (X Large) (All Pass); Ultimate Elongation= 500 % Min - 900.24 (Small), 836.57 (Medium), 839.47 (Large), 841.89 (X Large) (All Pass).
- After Accelerated Aging: Tensile Strength=14 MPa, min. - 23.54 (Small), 20.35 (Medium), 21.96 (Large), 21.2 (X Large) (All Pass); Ultimate Elongation= 400 % Min - 878.09 (Small), 813.34 (Medium), 851.65 (Large), 815.63 (X Large) (All Pass).
- Powder-free Residue exceeds maximum limit - ASTM D6124-06: 240 min.
- Carmustine, 3.3mg/ml: 26.6 min.
- Cisplatin, 1 mg/ml: >240 min.
- Cyclophosphamide, 20 mg/ml: >240 min.
- Dacarbazine, 10 mg/ml: >240 min.
- Doxorubicin HCl, 2mg/ml: >240 min.
- Etoposide, 20 mg/ml: >240 min.
- Fluorouracil, 50mg/ml: >240 min.
- Methotrexate, 25mg/ml: >240 min.
- Mitomycin C, 0.5mg/ml: >240 min.
- Mitoxantrone, 2mg/ml: >240 min.
- Oxaliplatin, 5 mg/ml: >240 min.
- Paclitaxel, 6 mg/ml: >240 min.
- Thiotepa, 10 mg/ml: 56.0 min.
- Vincristine Sulfate, 1mg/ml: >240 min.
- TEST OPIOD DRUGS: Fentanyl Citrate Injection, 100mcg/2mL: >240 min.
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 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.
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.
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
2
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 Breakthrough
Detection 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 Breakthrough
Detection 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 | | | |
| | Type of Use (Select one or both, as applicable) | | |
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) | | | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
5
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 Breakthrough
Detection 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 Breakthrough
Detection 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
6
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 Blue
Nitrile Glove- Blue Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate (Small, Medium, Large, X-
Large) | Predicate Device: K221269 Powder
Free Nitrile Examination Gloves
(Blue), Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate | Remarks |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | NA | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Different |
| Intended use | A powder free 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. The device
is for over- the- counter use. | 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).
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 | The glove is a disposable device
intended for medical purposes that is
worn on the examiner's hand to
prevent contamination between patient
and examiner. Gloves have been tested
for use with chemotherapy drugs and
Fentanyl Citrate using ASTM D6978-
05(2019).
Please note that the following drugs
have extremely low permeation times:
Carmustine: 11.1 minutes, Thiotepa:
21.6 minutes. Warning: Do not use
with 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 230mm
Width (±10mm)
Small - 80
Medium- 95
Large-110
X-large-120 | Overall Length (mm) Min 230mm
Small - 80
Medium- 95
Large-110
X-large-120 | Overall Length (mm) Min 230mm
Small - 80
Medium- 95
Large-110
X-large-120 | same |
| | Thickness at Palm (mm) Min; 0.05
mm | Thickness at Palm (mm) Min; 0.05 mm | Thickness at Palm (mm) Min; 0.05 mm | same |
| | Thickness at Finger Tip (mm) Min
0.05 mm | Thickness at Finger Tip (mm) Min 0.05
mm | Thickness at Finger Tip (mm) Min
0.05 mm | same |
| | a.Before Aging | | | |
| | Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | same |
| Physical
Properties | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | same |
| | Tensile Strength=14 MPa, min. | b. After Accelerated Aging
Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | same |
| | Ultimate Elongation= 400 % min | Ultimate Elongation= 400 % min | Ultimate Elongation= 400 % min | same |
| Freedom from
pinholes ASTM
D5151 | AQL 2.5 Inspection Level
G-1 | AQL 2.5 | AQL 2.5 | same |
| Residual Powder
ASTM D6124-06 | 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, 2
mg/ml(2,000 ppm) | >240 min. | >240 min. | same |
| | Oxaliplatin, 5 mg/ml(5,000
ppm) | >240 min. | >240 min. | same |
| | Paclitaxel, 6 mg/ml (6,000
ppm) | >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 for
Assessment of Resistance of | Busulfan 6mg/ml (6,000
ppm) | Not Tested | >240 min | Different |
| Medical Gloves to Permeation
by 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 BREAKTHROUGH
DETECTION TIME
(Specimen1/2/3) (Minutes) | AVERAGE STEADY STATE
PERM. 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.
7
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.
8
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 from | |||||||
| hole - ASTM | |||||||
| D5151-19 | AQL 2.5 | Pass | Pass | Pass | Pass | Pass | |
| Overall Length (mm) | |||||||
| Min 230mm. | 234 | 234.61 | 240 | 244 | Pass | ||
| Dimensions – | |||||||
| width, Length, | |||||||
| Thickness | |||||||
| AQL 4.0 | |||||||
| Inspection level | |||||||
| S-2 | Width (±10mm) | ||||||
| Small - 80 | |||||||
| Medium- 95 | |||||||
| Large-110 | |||||||
| X- large-120 | 84.69 | 96.15 | 111.7 | 119.07 | Pass | ||
| ASTM D6319- 19 | Thickness at | ||||||
| Palm & fingertip | |||||||
| Min: 0.05 mm | |||||||
| AQL 4.0 | |||||||
| Inspection level | |||||||
| S-2 | Palm | 0.09 | 0.09 | 0.1 | 0.1 | Pass | |
| Fingertip | 0.12 | 0.11 | 0.12 | 0.11 | Pass | ||
| a. Before Aging | |||||||
| Physical | |||||||
| properties before | |||||||
| aging, after | |||||||
| accelerated aging | |||||||
| AQL 4.0 | |||||||
| Inspection level | |||||||
| S-2 | Tensile Strength=14 | ||||||
| MPa, 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=14 | |||||||
| MPa, min. | 23.54 | 20.35 | 21.96 | 21.2 | Pass | ||
| Ultimate Elongation= | |||||||
| 400 % Min | 878.09 | 813.34 | 851.65 | 815.63 | Pass | ||
| Powder-free | |||||||
| Residue exceeds | |||||||
| maximum limit - | |||||||
| ASTM D6124-06 | 240 min. | N/A | Slight swelling and | ||||
| no 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 and | ||||||
| no degradation | |||||||
| 3 | Cisplatin, 1 mg/ml(1,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 4 | Cyclophosphamide, 20 mg/ml (20,000 | ||||||
| ppm) | >240 min. | N/A | Slight swelling and | ||||
| no degradation | |||||||
| 5 | Dacarbazine, 10 mg/ml (10,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 6 | Doxorubicin HCI, 2mg/ml (2,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 7 | Etoposide, 20 mg/ml(20,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 8 | Fluorouracil, 50mg/ml (50,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 9 | Methotrexate, 25mg/ml (25,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 10 | Mitomycin C, 0.5mg/ml (500 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 11 | Mitoxantrone, 2mg/ml (2,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 12 | Oxaliplatin, 5 mg/ml(5,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 13 | Paclitaxel, 6 mg/ml(6,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no 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 and | ||||||
| no degradation | |||||||
| 15 | Vincristine Sulfate, 1mg/ml (1,000 ppm) | >240 min. | N/A | Slight swelling and | |||
| no degradation | |||||||
| 16 | TEST OPIOD DRUGS | MINIMUM | |||||
| BREAKTHROUGH | |||||||
| DETECTION TIME | |||||||
| (Specimen1/2/3) (Minutes) | AVERAGE STEADY | ||||||
| STATEPERM. RATE | |||||||
| (Specimen1/2/3) | |||||||
| (µg/cm2/minute) | Other | ||||||
| OBSERVATIONS | |||||||
| Fentanyl Citrate Injection, 100mcg/2mL | >240 min | N/A | Slight swelling and | ||||
| no 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.