(33 days)
Not Found
No
The device description does not mention any AI, machine learning, or deep neural network components. It describes a physical examination glove.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, described as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." Its function is to prevent contamination, not to diagnose a medical condition.
No
The device is a physical medical device (patient examination glove made of synthetic rubber latex), not a software-only medical device. The description details physical properties, testing against chemotherapy drugs and fentanyl, and biocompatibility, all characteristic of a hardware device. There is no mention of software components or functionality.
No.
The device is a patient examination glove, which is a physical barrier for protection and does not involve the in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Table below shows the Summary Test Result for Resistance of Nitrile Powder Free Examination Glove (Blue & Black) to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
| Chemotherapy Drugs and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
*Please note that following drugs have extremely low permeation times:
- Carmustine (BCNU)
- Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs as below:
The subject devices are identical in design and formulation to the predicate gloves of K230121.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
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)
Non-clinical tests were conducted based on ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11.
Key results:
- Freedom From Holes: Passed at AQL 1.5, meeting requirement inspection level G-1, AQL 2.5
- Dimension: Passed, meeting min. length (220mm for XS, S and 230mm for M, L, XL), min. thickness (0.05mm), and width tolerances.
- Physical properties: Passed, meeting tensile strength (14MPa min. before and after aging) and ultimate elongation (500% min. before aging, 400% min. after aging).
- Residual Powder Content: Passed, meeting not more than 2 mg per glove.
- Biocompatibility:
- Primary Skin Irritation: Passed, concluded as not a primary skin irritant.
- Skin Sensitization: Passed, concluded as not a contact sensitizer.
- In Vitro Cytotoxicity: Showed moderate cytotoxicity reactivity at 6.0 cm²/mL extract concentrations and no reactivity at 3.0 cm²/mL extract concentrations.
- Acute Systemic Toxicity: Passed, showed no adverse biological reaction.
The subject device was also tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019). The minimum breakthrough detection times for various drugs were provided in a table, with most showing >240 minutes, except for Carmustine (BCNU) and Thio Tepa, which had significantly lower times (22.6 and 43.9 minutes for blue gloves, 21.8 and 17.7 minutes for black gloves, respectively). A warning was issued not to use the gloves with Carmustine and Thio Tepa due to their extremely low permeation times.
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.
FDA 510(k) Clearance Letter - K250578
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 1, 2025
Careglove Global Sdn. Bhd.
Lim Shyan
Managing Director
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3,
Senawang Indsutrial Estate
Seremban, Negeri Sembilan 70450
Malaysia
Re: K250578
Trade/Device Name: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
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: February 19, 2025
Received: February 27, 2025
Dear Lim Shyan:
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 (the 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 available 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.
Page 2
K250578 - Lim Shyan Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250578 - Lim Shyan Page 3
assistance/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
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): 250578
Device Name: NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)
Indications for Use (Describe)
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Table below shows the Summary Test Result for Resistance of Nitrile Powder Free Examination Glove (Blue & Black) to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
| Chemotherapy Drugs and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
*Please note that following drugs have extremely low permeation times:
- Carmustine (BCNU)
- Thio Tepa
Warning: 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.
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(K) SUMMARY
Applicant Name: CAREGLOVE GLOBAL SDN BHD
Location: Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3,
Senawang Indsutrial Estate
Seremban, Negeri Sembilan 70450
Malaysia
Phone No: (60) 6 6782377
Fax No: (60) 6 6785377
Contact Person: Murni Razali
Summary Preparation Date: March 27,2025
Device Information
Trade Name: NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)
Common Name: POWDER FREE NITRILE EXAMINATION GLOVES
Classification Name: Non-Powdered Patient Examination Gloves
Product Code: LZA, LZC, QDO, OPJ
Regulation: 21 CFR 880.6250
Predicate Device
Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), 510(K) number K230121 product code LZA, LZC, QDO, OPJ.
Device Description
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs as below:
The subject devices are identical in design and formulation to the predicate gloves of K230121.
Page 1 of 6
Page 6
Page 2 of 6
| Chemotherapy Drugs and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
*Please note that following drugs have extremely low permeation times:
- Carmustine (BCNU)
- Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Indications for Use
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Table below shows the Summary Test Result for Resistance of Nitrile Powder Free Examination Glove (Blue & Black) to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
| Chemotherapy Drugs and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|---|---|---|---|
| Blue | Black | ||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
*Please note that following drugs have extremely low permeation times:
- Carmustine (BCNU)
- Thio Tepa
Warning: Do not use with Carmustine and Thiotepa
Page 7
Page 3 of 6
Summary of The Technological Characteristic
The Nitrile Examination Gloves Powder Free – Blue & Black, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Predicate Device K230121 | Subject Device K250578 | Remarks |
|---|---|---|---|---|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Intended Use | - | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner | Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner | Same |
| Design | - | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff | Same |
| Indications for Use | - | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| Construction | - | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | Same |
| Color Description | - | Blue & Black | Blue & Black | Same |
| Material | - | Nitrile | Nitrile | Same |
| Single Use | - | Yes | Yes | Same |
| Packaging | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same |
| Chemo Drugs Claim | - | 12 Chemotherapy Drugs & Fentanyl Citrate claim | 14 Chemotherapy Drugs & Fentanyl Citrate claim | Different |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Dimension | ASTM D6319-19 | |||
| Length XS, S | Meet 220mm min | Meet 220mm min | Same | |
| M, L, XL | Meet 230mm min | Meet 230mm min | Same | |
| Thickness (palm), Thickness (finger), | Meet 0.05mm min Meet 0.05mm min | Meet 0.05mm min Meet 0.05mm min | Same | |
| Width | XS: Meet 70 ± 10 mm S: Meet 80 ± 10 mm M: Meet 95 ± 10 mm L: Meet 110 ± 10 mm XL: Meet 120 ± 10 mm | XS: Meet 70 ± 10 mm S: Meet 80 ± 10 mm M: Meet 95 ± 10 mm L: Meet 110 ± 10 mm XL: Meet 120 ± 10 mm | Same |
Page 8
Page 4 of 6
| Characteristic | Standard | Predicate Device K230121 | Subject Device K250578 | Remarks |
|---|---|---|---|---|
| Physical Properties | ||||
| (Before Ageing) | ASTM D6319-19 | |||
| i) Tensile Strength (MPa) | Meet 14MPa min. | Meet 14MPa min. | Same | |
| ii) Ultimate Elongation (%) | Meet 500% min | Meet 500% min | ||
| (After Aging) | ||||
| i) Tensile Strength (MPa) | Meets 14MPa min | Meets 14MPa min | Same | |
| ii) Ultimate Elongation (%) | Meet 400% min. | Meet 400% min. | ||
| Water Leak Test, 1000 ml | ||||
| Before Aging, AQL | ASTM D6319-19 ASTM D5151-19 | Passes at AQL 1.5 | Passes at AQL 1.5 | Same |
| Powder Free Residue | ||||
| Powder Free Residue, mg/glove | ASTM D6319-19 ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max | Same |
| Biocompatibility Test | ||||
| i) Primary Skin Irritation Test | ISO 10993-10 | Passes Conclusion: Under the conditions of this study the test material did not cause an irritant response | Passes Conclusion: Under the conditions of this study the test material did not cause an irritant response | Same |
| ii) Skin Sensitization Test | ISO 10993-10 | Passes Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect | Passes Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect | Same |
| iii) In Vitro Cytotoxicity Test | ISO 10993-5:2009 | Conclusion: Under condition of this study, test material exhibited moderate cytotoxicity reactivity at 6.0 cm2/mL extract concentrations and no cytotoxicity reactivity at the 3.0 cm2/mL extract concentrations of the test. | Conclusion: Under condition of this study, test material exhibited moderate cytotoxicity reactivity at 6.0 cm2/mL extract concentrations and no cytotoxicity reactivity at the 3.0 cm2/mL extract concentrations of the test. | Same |
| Iv) Acute Systemic Toxicity | ISO 10993-11 | Conclusion: Under condition. of this study, the test material showed no adverse biological reaction after administration of the sample's extract on the rats during the period of the study. | Conclusion: Under condition. of this study, the test material showed no adverse biological reaction after administration of the sample's extract on the rats during the period of the study. | Same |
Page 9
Page 5 of 6
Test Results for Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (ASTM D6978-05):
| Chemotherapy Drug and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) | Remark | |||
|---|---|---|---|---|---|---|
| Proposed Device | Predicate Device | |||||
| Blue | Black | Blue | Black | |||
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 | 22.6 | 21.8 | Same |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Etoposide | 20.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 | 43.9 | 17.7 | Same |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min | >240 min | >240 min | Same |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min | Not Tested | Not Tested | Different |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min | Not Tested | Not Tested | Different |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min | >240 min | >240 min | Same |
| Warning | Please note that following drugs have extremely low permeation times: 1. Carmustine (BCNU) (3.3 mg/ml) 2. Thio Tepa (10 mg/ml) | Please note that following drugs have extremely low permeation times: 1. Carmustine (BCNU) (3.3 mg/ml) 2. Thio Tepa (10 mg/ml) | Same |
Page 10
Page 6 of 6
Summary of Non-Clinical Testing
Following is a table showing the actual measured parameters of the gloves (e.g length, thickness, physical properties, etc.) as compared to ASTM, EN and ISO. All data meets the standard reference requirement.
| Test | Method | Acceptance Criteria | Result |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19 ASTM D5151-19 | Meet requirement inspection level G-1, AQL 2.5 | Pass |
| Dimension | ASTM D6319-19 | Pass | |
| Physical properties | ASTM D6319-19 | Pass |
| Size | XSmall | Small | Medium | Large | XLarge |
|---|---|---|---|---|---|
| Length, min. mm | 220 | 230 | |||
| Thickness, min. mm | 0.05 | ||||
| Width, ± 10 mm | 70 | 80 | 95 | 110 | 120 |
| Before Aging | After Accelerated Aging | |||
|---|---|---|---|---|
| Tensile Strength | Ultimate Elongation | Tensile Strength | Ultimate Elongation | |
| 14 MPa min. | 500% min. | 14 MPa min. | 400 % min. |
| Residual Powder Content | ASTM D6319-19 ASTM D6124-06 | Not more than 2 mg per glove | Pass |
|---|---|---|---|
| Biocompatibility | |||
| i) Primary Skin Irritation | ISO 10993-10 | Not a primary skin irritant | Pass |
| ii) Skin Sensitization | ISO 10993-10 | Not a contact sensitizer | Pass |
| iii) In Vitro Cytotoxicity | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicity reactivity at 6.0 cm²/mL and no reactivity at 3.0 cm²/mL extract concentrations |
| iv) Acute Systemic | ISO 10993-11 | No adverse biological reaction | Pass |
Summary of Clinical Testing
Not applicable.
CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K230121, Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate (Blue & Black).