Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Device Facts
| Record ID | K222181 |
|---|---|
| Device Name | Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate |
| Applicant | Iconic Medicare Sdn Bhd |
| Product Code | LZA · General Hospital |
| Decision Date | Jan 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
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).
Device Story
Disposable, non-sterile, powder-free nitrile examination glove; worn by healthcare examiners to prevent cross-contamination. Device provides a physical barrier; tested for permeation resistance against specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Output is the physical barrier itself; used in clinical settings. Healthcare providers use the glove to protect themselves and patients during handling of hazardous drugs. Benefits include reduced exposure to chemotherapy agents and opioids during patient care.
Clinical Evidence
Bench testing only. No clinical data was used to assess performance. Testing included physical properties (tensile strength, elongation), freedom from pinholes (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993-5, -10, -11). Permeation testing performed per ASTM D6978-05 for 15 chemotherapy drugs and Fentanyl Citrate.
Technological Characteristics
Material: Nitrile compound. Form factor: Disposable, non-sterile, powder-free glove. Sizes: Small, Medium, Large, X-Large. Standards: ASTM D6319-19 (nitrile examination gloves), ASTM D6978-05 (chemotherapy drug permeation), ISO 10993 (biocompatibility).
Indications for Use
Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (2019). Contraindicated for use with Carmustine and Thiotepa due to low permeation times.
Regulatory Classification
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.
Predicate Devices
- Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)
Submission Summary (Full Text)
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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 Breakthrough<br>Detection Time<br>(Specimen 1,2,3)<br>(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<br>Detection Time<br>(Specimen 1,2,3)<br>(Minutes) |
| 16 | Fentanyl Citrate Injection | 100mcg/2mL | >240 min. |
| Please note that the following drugs have low permeation times:<br>Carmustine: 26.6 minutes<br>Thiotepa: 56.0 minutes<br>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)<br>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 Breakthrough<br>Detection Time<br>(Specimen 1,2,3)<br>(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<br>Detection Time<br>(Specimen 1,2,3)<br>(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 Blue<br>Nitrile Glove- Blue Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate (Small, Medium, Large, X-<br>Large) | Predicate Device: K221269 Powder<br>Free Nitrile Examination Gloves<br>(Blue), Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate | Remarks |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | NA | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Different |
| Intended use | A powder free patient<br>examination glove is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. The device<br>is for over- the- counter use. | A patient examination glove is a<br>disposable device intended for medical<br>purpose that is worn on the examiner's<br>hand or finger to prevent contamination<br>between patient and examiner. These<br>gloves were tested for use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate as per ASTM D6978-05 (2019).<br>Please note that the following drugs have<br>low permeation times: Carmustine: 26.6<br>minutes, Thiotepa: 56.0 minutes<br>Warning - Please do not use with<br>Carmustine and Thiotepa | The glove is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between patient<br>and examiner. Gloves have been tested<br>for use with chemotherapy drugs and<br>Fentanyl Citrate using ASTM D6978-<br>05(2019).<br>Please note that the following drugs<br>have extremely low permeation times:<br>Carmustine: 11.1 minutes, Thiotepa:<br>21.6 minutes. Warning: Do not use<br>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<br>Width (±10mm)<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120 | Overall Length (mm) Min 230mm<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120 | Overall Length (mm) Min 230mm<br>Small - 80<br>Medium- 95<br>Large-110<br>X-large-120 | same |
| | Thickness at Palm (mm) Min; 0.05<br>mm | Thickness at Palm (mm) Min; 0.05 mm | Thickness at Palm (mm) Min; 0.05 mm | same |
| | Thickness at Finger Tip (mm) Min<br>0.05 mm | Thickness at Finger Tip (mm) Min 0.05<br>mm | Thickness at Finger Tip (mm) Min<br>0.05 mm | same |
| | a.Before Aging | | | |
| | Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | Tensile Strength=14 MPa, min. | same |
| Physical<br>Properties | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | Ultimate Elongation= 500 % min | same |
| | Tensile Strength=14 MPa, min. | b. After Accelerated Aging<br>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<br>pinholes ASTM<br>D5151 | AQL 2.5 Inspection Level<br>G-1 | AQL 2.5 | AQL 2.5 | same |
| Residual Powder<br>ASTM D6124-06 | < 2.0 mg/pc | < 2.0 mg/pc | < 2.0 mg/pc | same |
| | ISO 10993-10:2010 Biological<br>evaluation of medical devices -<br>Part 10: Tests for irritation and skin<br>sensitization | Under the conditions of this study, the test<br>article was a non- sensitizer. | Under the conditions of this study, the<br>test article was a non- sensitizer. | same |
| | ISO 10993-10:2010 Biological<br>evaluation of medical devices -<br>Part 10: Tests for irritation and skin<br>sensitization | Under the conditions of this study, the test<br>article was a non-Irritant | Under the conditions of this study, the<br>test article was a non-Irritant | same |
| | ISO 10993-5:2009 Biological<br>evaluation of medical devices -<br>Part 5: Tests for in vitro<br>cytotoxicity | Non-Cytotoxic to L929 cells | Under the conditions of this study,<br>the test article extract showed<br>potential toxicity to L929 cells | Different |
| | ISO 10993-11:2017 Biological<br>evaluation of medical devices -<br>Part 11 · Tests for systemic toxicity | Not induce acute systemic toxicity | Under the conditions of this study,<br>there was no evidence of acute<br>systemic toxicity | same |
| | | | | |
| | TEST<br>CHEMOTHERAPY<br>DRUGS &<br>Concentration | Subject device: Iconic Blue Nitrile<br>Glove- Blue Tested for Use with<br>Chemotherapy Drugs and Fentanyl<br>Citrate (Small, Medium, Large, X-<br>Large) | Predicate Device K221269<br>Powder Free Nitrile<br>Examination Gloves (Blue),<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate | Remarks |
| | | MINIMUM BREAKTHROUGH DETECTION TIME<br>(Minutes) | | |
| | Carboplatin, 10 mg/ml<br>(10,000 ppm) | >240 min. | >240 min. | same |
| | Carmustine, 3.3 mg/ml<br>(3,300 ppm) | 26.6 | 11.1 | Different |
| | Cisplatin, 1 mg/ml (1,000 | >240 min. | >240 min. | same |
| | ppm)<br>Cvclophosphamide. | >240 min. | >240 min. | same |
| | 20mg/ml (20,000 ppm)<br>Dacarbazine, 10 mg/ml | >240 min. | >240 min. | same |
| | (10,000 ppm)<br>Doxorubicin HCI, 2mg/ml | >240 min. | >240 min. | same |
| | (2,000 ppm)<br>Etoposide, 20 | >240 min. | >240 min. | same |
| | mg/ml(20,000 ppm)<br>Fluorouracil, 50 | | | |
| | mg/ml(50,000 ppm)<br>Methotrexate, 25 | >240 min. | >240 min. | same |
| | mg/ml(25,000 ppm)<br>Mitomycin C, 0.5 mg/ml | >240 min. | >240 min. | same |
| | (500 ppm) | >240 min. | >240 min. | same |
| | Mitoxantrone, 2<br>mg/ml(2,000 ppm) | >240 min. | >240 min. | same |
| | Oxaliplatin, 5 mg/ml(5,000<br>ppm) | >240 min. | >240 min. | same |
| | Paclitaxel, 6 mg/ml (6,000<br>ppm) | >240 min. | >240 min. | same |
| | Thiotepa, 10 mg/ml<br>(10,000 ppm) | રેણ | 21.6 | Different |
| D6978-05 (Reapproved 2019) | Vincristine Sulfate, 1 mg/ml<br>(1,000 ppm) | >240 min. | >240 min. | same |
| Standard Practice for<br>Assessment of Resistance of | Busulfan 6mg/ml (6,000<br>ppm) | Not Tested | >240 min | Different |
| Medical Gloves to Permeation<br>by Chemotherapy Drugs | Chloroquine 50mg/ml<br>(50,000ppm) | Not Tested | >240 min | Different |
| | Cyclosporin 100 mg/ml | Not Tested | >240 min | Different |
| | (100,000 ppm)<br>Cytarabine HCL, 100 | Not Tested | >240 min | Different |
| | mg/ml (100,000 ppm)<br>Daunorubicin HCL, 5 | Not Tested | >240 min | Different |
|…
