(189 days)
Not Found
No.
The device described is a medical glove, which is a physical product and does not involve any computational or data processing components that would leverage an AI model. The document details its material, physical properties, and resistance to chemicals, none of which suggest the presence of AI.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a medical condition or disease.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is not designed to diagnose any condition or disease.
No
The device is a physical medical glove intended to prevent contamination and resist chemical permeation. It is a tangible, hardware product and includes no mention of software components, algorithms, or digital functionalities.
No.
This device is a patient examination glove used to prevent contamination between patient and examiner. It does not perform an 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 to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.
The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
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 Performance Testing:
Test Method: ASTM D6319
Purpose: Physical Dimensions Test
Acceptance Criteria:
Length:
S: ≥220mm
M/L/XL: ≥230mm
Width:
S: 80±10 mm
M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
Thickness:
Palm: ≥0.05 mm
Finger: ≥0.05 mm
Results:
Length:
S: ≥220mm
M/L/XL: ≥230mm
Width:
S: 86-88/Pass
M: 98-99/Pass
L: 105-110/Pass
XL: 117-119/Pass
Thickness:
Palm:
S-XL:0.06/Pass
Finger:
S-L: 0.08/Pass
XL: 0.09/Pass
Test Method: ASTM D5151 ASTM D6319
Purpose: Watertightness Test for Detection of Holes
Acceptance Criteria: Meet AQL 2.5 with G1
Results: Meet AQL 2.5 with G1
Test Method: ASTM D6124 ASTM D6319
Purpose: Powder Content
Acceptance Criteria: Meet the requirement of ASTM D 6124-06 ≤2.0mg
Results: S: 0.63mg/glove M: 1.02mg/glove L: 0.28mg/glove XL: 0.38mg/glove Pass
Test Method: ASTM D412 ASTM D6319
Purpose: Physical Properties
Acceptance Criteria:
Tensile Strength:
before aging ≥14 Mpa
after aging ≥14 Mpa
Ultimate Elongation:
before aging ≥500 %
after aging ≥400%
Results:
Tensile Strength:
Before aging: Pass
After aging: Pass
Ultimate Elongation:
Before aging: Pass
After aging: Pass
Test Method: ASTM D6978
Purpose: Chemotherapy drug and Fentanyl Citrate claim
Acceptance Criteria: The subject device was tested for use with chemotherapy drugs and Fentanyl Citrate
Results: The following chemotherapy drugs and Fentanyl Citrate concentration had NO breakthrough detected up to 240 minutes and can be used with the device.
Cisplatin (1mg/ml)
Cyclophosphamide (20.0 mg/ml), Dacarbazine (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0 mg/ml),
Methotrexate (25mg/ml),
Mitomycin (0.5mg/ml),
Oxaliplatin (5mg/ml),
Paclitaxel (6.0 mg/ml),
Vincristine (1mg/ml),
Fentanyl Citrate Injection 100mcg/2ml
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 22.5 minutes ThioTEPA (10.0 mg/ml): 34.5 minutes
Test Method: ISO 10993-5
Purpose: Cytotoxicity
Acceptance Criteria: Non-cytotoxic
Results: Under conditions of the study, device extract is cytotoxic.
Test Method: ISO 10993-23
Purpose: Irritation
Acceptance Criteria: Non-irritating
Results: Under the conditions of the study, device is not an irritant. / Pass
Test Method: ISO 10993-10
Purpose: Sensitization
Acceptance Criteria: Non-sensitizing
Results: Under the conditions of the study, device is not a sensitizer. / Pass
Test Method: ISO 10993-11
Purpose: Acute Systemic Toxicity
Acceptance Criteria: Non-acute systemic toxicity
Results: Under the conditions of the study, device did not show acute systemic toxicity in vivo. /pass
Test Method: ISO 11737-1:2018
Purpose: Bioburden Determination
Acceptance Criteria: ≤ 200 CFU/device
Results: 80-119 CFU/glove
Test Method: USP
Purpose: Material-Mediated Pyrogenicity
Acceptance Criteria: Non-pyrogenic
Results: Under the conditions of the study, non-pyrogenic
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 - K243694
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 6, 2025
Mah Sing Healthcare Sdn. Bhd.
Ivan Tan Chee Wei
Deputy General Manager, QA&RA
Lot 6478, Lorong Sungai Puloh/KU6,
Kawasan Industri Sungai Puloh,
Klang, Selangor 42100
Malaysia
Re: K243694
Trade/Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
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: November 29, 2024
Received: November 29, 2024
Dear Ivan Tan Chee Wei:
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
K243694 - Ivan Tan Chee Wei 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
K243694 - Ivan Tan Chee Wei 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,
ALLAN GUAN -S
For Bifeng Qian, M.D, Ph.D.
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): K243694
Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Indications for Use (Describe)
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 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.
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.
FORM FDA 3881 (8/23) Page 1 of 2
Page 5
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): K243694
Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Indications for Use (Describe)
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 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 22.5 minutes
(2) Thiotepa – 34.5 minutes.
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 2 of 2
Page 6
1 of 8
Premarket Notification [510(k)] No: K243694
510 (K) SUMMARY
1.0 Submitter name/Contact details
Mah Sing Healthcare Sdn Bhd
Lot 6478, Lorong Sungai Puloh/KU6,
Kawasan Industri Sungai Puloh,
Klang, Selangor 42100
MALAYSIA
Name: Ivan Tan Chee Wei (Mr)
Title: Deputy General Manager, QA&RA
E-mail: ivan.tan@mshealthcare.com
Tel: +60-3-3396 2288, Extn: 2213
Fax: +60-3-3396 2299
2.0 Summary
Preparation Date: June 6, 2025
3.0 Device Name & Classification
Trade Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extracts, Tested For Use with Chemotherapy Drugs and Fentanyl Citrate – Blue
Common Name: Nitrile Powder Free Patient Examination Glove
Classification Name: Polymer Patient Examination Glove
Classification Panel: General Hospital
Classification Regulation: 21 CFR 880.6250
Device Classification: I
Product Code: LZA, LZC, OPJ, QDO
4.0 Identification of Predicate Device
Trade Name: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
510(k) Number: K240080
Product Code: LZA, LZC, OPJ, QDO
Manufacture's Name: Syntex Healthcare Products Co., Ltd.
5.0 Description of Device
The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.
The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
Page 7
2 of 8
6.0 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 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 22.5 minutes
(2) Thiotepa – 34.5 minutes.
Page 8
3 of 8
7.0 Summary of the Technological Characteristic
Table 1
| Characteristics and Parameters | Standard | Proposed Device (K243694) | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Trade Name | - | Nitrile Powder Free Examination Gloves with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate – Blue | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | *Different |
| Regulation Number | 21 CFR Part 880.6250 | 21 CFR Part 880.6250 | 21 CFR Part 880.6250 | Same |
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Material | ASTM D 6319-19 | Nitrile Butadiene Rubber | Synthetic Nitrile Rubber | Same |
| Indication 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 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | 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 has been tested for use with Chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05 (2019). | Same | |
| Design | 1. Single use |
- Non-sterile
- Powder free
- Ambidextrous
- Beaded cuff
- Fingertip Textured | 1. Single use
- Non-sterile
- Powder free
- Ambidextrous
- Beaded cuff | Similar |
| Color | - | Blue | Green | **Different |
| Coating | - | Tremella Fuciformis coated on the donning surface | Aloe coated on the donning surface | ***Different |
- The trade name will be provided on the labeling, so the difference does not affect the safety and effectiveness of the device.
** The subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not affect the safety and effectiveness of the device.
*** The subject device contains Tremella Fuciformis, while the predicate device uses Aloe. Both ingredients are non-animal derived. Biocompatibility testing for both devices is identical, and the subject device has passed the performance testing, all of which met the required standards. Therefore, the difference in coating does not affect the safety and effectiveness of the device.
Page 9
4 of 8
| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Chemotherapy Drug Permeation Test | ASTM D6978-05 | |||
| Tested Chemotherapy Drugs and Fentanyl citrate | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine | 3.3mg/ml | 22.5 | 21.2 | |
| Cisplatin | 1 mg/ml | >240 | >240 | |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | |
| Dacarbazine | 10 mg/ml | >240 | >240 | |
| Doxorubicin, HCl | 2 mg/ml | >240 | >240 | |
| Etoposide | 20 mg/ml | >240 | >240 | |
| Fluorouracil | 50 mg/ml | >240 | >240 | |
| Methotrexate | 25 mg/ml | >240 | >240 | |
| Mitomycin | 0.5 mg/ml | >240 | >240 | |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | |
| Paclitaxel | 6 mg/ml | >240 | >240 | |
| *Thiotepa | 10 mg/ml | 34.5 | 24.9 | |
| Vincristine | 1 mg/ml | >240 | >240 | |
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 | >240 |
*The labeling of the subject device will include information on the minimum breakthrough time for chemotherapy drugs. This difference, along with the similarities to the predicate device, does not affect the safety or effectiveness of the device.
| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Length | S: Min.220mm | |||
| M: Min.230mm | ||||
| L: Min.230mm | ||||
| XL: Min.230mm | ASTM D 6319-19 | S: 242 - 251mm | ||
| M: 245 - 253mm | ||||
| L: 247 - 255mm | ||||
| XL: 249- 255mm | XS: 220mm | |||
| S: 220mm | ||||
| M: 230mm | ||||
| L: 230mm | ||||
| XL: 230mm | ||||
| XXL: 230mm | *Similar | |||
| Width | S: 70mm – 90mm | |||
| M: 85mm – 105mm | ||||
| L: 100mm – 120mm | ||||
| XL:110mm – 130mm | ASTM D 6319-19 | S: 86 - 88mm | ||
| M: 98 - 99mm | ||||
| L: 105 - 110mm | ||||
| XL: 117 - 119mm | XS: 70 ± 10mm | |||
| S: 80 ± 10mm | ||||
| M: 95 ± 10mm | ||||
| L: 110 ± 10mm | ||||
| XL: 120 ± 10mm | ||||
| XXL: 130 ± 10mm | *Similar | |||
| Finger Thickness (Minimum 0.05mm) | ASTM D 6319-19 | S: Minimum 0.08mm | ||
| M: Minimum 0.08mm | ||||
| L: Minimum 0.08mm | ||||
| XL: Minimum 0.09mm | Minimum 0.05 | Similar |
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5 of 8
| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Palm Thickness (Minimum 0.05mm) | ASTM D 6319-19 | S: Minimum 0.06mm | ||
| M: Minimum 0.06mm | ||||
| L: Minimum 0.06mm | ||||
| XL: Minimum 0.06mm | Minimum 0.05 | Similar | ||
| Tensile Strength (Before aging) Minimum 14 MPa | ASTM D 6319-19 | S: Minimum 33MPa | ||
| M: Minimum 35MPa | ||||
| L: Minimum 36MPa | ||||
| XL: Minimum 34MPa | Minimum 14 MPa | Similar | ||
| Ultimate Elongation (before aging) Minimum 500% | ASTM D 6319-19 | S: Minimum 551% | ||
| M: Minimum 541% | ||||
| L: Minimum 531% | ||||
| XL: Minimum 523% | Minimum 500% | Similar | ||
| Tensile Strength (After accelerated aging) Minimum 14 MPa | ASTM D 6319-19 | S: Minimum 34MPa | ||
| M: Minimum 35MPa | ||||
| L: Minimum 34MPa | ||||
| XL: Minimum 34MPa | Minimum 14 MPa | Similar | ||
| Ultimate Elongation (after accelerated aging) Minimum 400% | ASTM D 6319-19 | S: Minimum 532% | ||
| M: Minimum 523% | ||||
| L: Minimum 505% | ||||
| XL: Minimum 504% | Minimum 400% | Similar | ||
| Freedom of Holes Meet AQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 | Same |
| Residual powder test (Less than 2mg/glove) | ASTM D 6124-06 | S: 0.63mg/glove | ||
| M: 1.02mg/glove | ||||
| L: 0.28mg/glove | ||||
| XL: 0.38mg/glove | ≤ 2mg per glove | Similar | ||
| In vitro Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under the condition of this test, exhibited cytotoxicity reactivity from 100.0% extract concentration to 25.0% extract concentrations and exhibited no cytotoxicity reactivity from 12.5% extract concentration to 3.125% extract concentrations. | Under the condition of this study, the test article showed potential toxicity to L929 cells. | Similar |
| Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | Under the conditions of the study, there is no adverse acute toxic reaction. | Under the conditions of this study, no evidence of acute systemic toxicity from the test article | Similar |
| Animal Irritation Test | ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation | Under the conditions of the study, not an irritant | The test result showed that the response of the test article was categorized as negligible under the test condition. | Similar |
| Dermal Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Under the conditions of the study, no evidence of skin sensitization. | Under the conditions of this study, the test article showed no evidence of causing skin sensitization | Similar |
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| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Bioburden | ISO 11737-1:2018 Sterilization of health care products — Microbiological methods - Part 1: Determination of a population of microorganisms on products | ≤ 200 CFU/device | Not performed | **Different |
| Material-mediated pyrogenicity | USP | Under the conditions of the study, non-pyrogenic | Not performed | **Different |
- The predicate device is available in sizes XS and XXL, while the subject device does not offer these sizes. However, the subject device has been tested according to ASTM D6319-19 for dimensional requirements and has met all applicable standards. Therefore, the difference in sizes does not affect the safety and effectiveness of the device.
**Additional tests were performed to address safety concerns with fungal-derived material.
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8.0 Summary of Non-Clinical Performance Testing
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length: | |
| S: ≥220mm | |||
| M/L/XL: ≥230mm |
Width:
S: 80±10 mm
M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
Thickness:
Palm: ≥0.05 mm
Finger: ≥0.05 mm | Length:
S: ≥220mm
M/L/XL: ≥230mm
Width:
S: 86-88/Pass
M: 98-99/Pass
L: 105-110/Pass
XL: 117-119/Pass
Thickness:
Palm:
S-XL:0.06/Pass
Finger:
S-L: 0.08/Pass
XL: 0.09/Pass |
| ASTM D5151 ASTM D6319 | Watertightness Test for Detection of Holes | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 |
| ASTM D6124 ASTM D6319 | Powder Content | Meet the requirement of ASTM D 6124-06
≤2.0mg | S: 0.63mg/glove
M: 1.02mg/glove
L: 0.28mg/glove
XL: 0.38mg/glove Pass |
| ASTM D412 ASTM D6319 | Physical Properties | Tensile Strength:
before aging ≥14 Mpa
after aging ≥14 Mpa
Ultimate Elongation:
before aging ≥500 %
after aging ≥400% | Tensile Strength:
Before aging: Pass
After aging: Pass
Ultimate Elongation:
Before aging: Pass
After aging: Pass |
| ASTM D6978 | Chemotherapy drug and Fentanyl Citrate claim | The subject device was tested for use with chemotherapy drugs and Fentanyl Citrate | The following chemotherapy drugs and Fentanyl Citrate concentration had NO breakthrough detected up to 240 minutes and can be used with the device.
Cisplatin (1mg/ml),
Cyclophosphamide (20.0 mg/ml), Dacarbazine (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml) |
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Fluorouracil (50.0 mg/ml),
Methotrexate (25mg/ml),
Mitomycin (0.5mg/ml),
Oxaliplatin (5mg/ml),
Paclitaxel (6.0 mg/ml),
Vincristine (1mg/ml),
Fentanyl Citrate Injection 100mcg/2ml
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 22.5 minutes
ThioTEPA (10.0 mg/ml): 34.5 minutes
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic. |
| ISO 10993-23 | Irritation | Non-irritating | Under the conditions of the study, device is not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, device is not a sensitizer. / Pass |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | Under the conditions of the study, device did not show acute systemic toxicity in vivo. /pass |
| ISO 11737-1:2018 | Bioburden Determination | ≤ 200 CFU/device | 80-119 CFU/glove |
| USP | Material-Mediated Pyrogenicity | Non-pyrogenic | Under the conditions of the study, non-pyrogenic |
9.0 Summary of Clinical Testing
Clinical Testing is not needed for this device.
10.0 Conclusion
The conclusion drawn from the nonclinical test demonstrates that the subject device Nitrile Powder Free Examination Gloves with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate – Blue is as safe, as effective, and performs as well as or better than the legally marketed predicate device K240080.