(112 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a disposable glove, with no mention of AI or ML.
No.
The device's intended use is to prevent contamination between patient and examiner, not to treat or cure a disease or condition. It acts as a barrier, which is a prophylactic or protective function rather than a therapeutic one.
No
The device is a medical glove intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly outlines its material (nitrile), physical characteristics (powder free, ambidextrous, beaded cuff), and testing against physical standards (ASTM, ISO).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states the 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." Its primary function is a barrier to prevent the transfer of contaminants.
- Lack of Specimen Examination: The device does not examine any specimens from the human body. It is a physical barrier used during medical procedures.
- Testing for Chemical Resistance: While the glove is tested for use with chemotherapy drugs and Fentanyl Citrate, this testing relates to the glove's barrier properties and resistance to these substances, not to the diagnosis or monitoring of a patient's condition based on a specimen.
The information provided aligns with the description of a medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but not an IVD.
N/A
Intended Use / Indications for Use
The 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 glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).
The following chemicals have been tested with these gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |
|---|---|---|
| Blue | Black | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 14.7, Do not use | 22.6, Do not use |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4, Do not use | 35.6, Do not use |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | |
| Blue | Black | |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 14.7 minutes, Thio Tepa: 36.4 minutes (Blue);
Carmustine: 22.6 minutes, Thio Tepa: 35.6 minutes (Black);
Warning: Do not use with Carmustine and Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO, OPJ
Device Description
The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands or fingers of the examiner
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (for 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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19(2023) | To determine the length of the gloves | XS: $\geq$ 220 mm S: $\geq$ 220 mm M: $\geq$ 230 mm L: $\geq$ 230 mm XL: $\geq$ 230 mm XXL: $\geq$ 230 mm | Pass Meet the requirements of ASTM D6319 |
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Palm Width) | XS: 70±10mm S: 80±10mm M: 95±10mm L:110±10mm XL:120±10mm XXL:130±10mm | Pass Meet the requirements of ASTM D6319 |
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Thickness) | Finger: 0.05mm (min) Palm: 0.05mm (min) | Pass Meet the requirements of ASTM D6319 |
| ASTM D6319-19(2023) ASTM D412-16(2021) | To determine the Physical Properties | Tensile Strength (Min14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass Meet the requirements of ASTM D6319 |
| ASTM D6319-19(2023) ASTM D5151-19(2023) | To determine the Water leak test | AQL 2.5 | Pass Meet the requirements of ASTM D6319 |
| ASTM D6319-19(2023) ASTM D6124-06 (2022) | To determine the Powder Residue | Max 2mg/glove | Pass Meet the requirements of ASTM D6319 |
| ASTM D6978-05 (2023) | chemical permeation testing | / | Refer to the above table [Chemotherapy Permeation and Fentanyl Citrate Comparison Table] |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. |
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the SC and SO test article extracts, respectively |
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity reactivity | The test article extract showed evidence of causing severe cell lysis or toxicity. Toxicity concerns was addressed by Acute Systemic Toxicity testing. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2025
Sunray Medical Products Inc. Youyou Zheng General Manager 3973 Schaefer Ave. Chino, California 91710
Re: K242936
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: December 20, 2024 Received: December 20, 2024
Dear Youyou Zheng:
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.
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"
1
(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 OS 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 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-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 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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
2
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
3
Indications for Use
510(k) Number (if known) K242936
Device Name
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentaxy) Citrate
Indications for Use (Describe)
The 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 glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023)
The following chemicals have been tested with these gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |
|---|---|---|
| Blue | Black | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 14.7, Do not use | 22.6, Do not use |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4, Do not use | 35.6, Do not use |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | |
| Blue | Black | |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 14.7 minutes, Thio Tepa: 36.4 minutes (Blue);
Carmustine: 22.6 minutes, Thio Tepa: 35.6 minutes (Black);
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summarv
510(k) Number: _K242936
Submitter's Information: 1.
Name: Sunray Medical Products Inc. Address: 3973 Schaefer Ave. Chino, California, 91710, United States Contact: Ms Youyou Zheng / General Manager Tel: 909 590 1611 Email: fdareg@sunraymedicalinc.com Date Prepared: December 18, 2024
Device Identification: 2.
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Patient Examination Gloves Classification Name: Non-powdered Patient Examination Glove Regulation Number: 21 CFR 880.6250 Product Code: LZA LZC QDO OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Genabio Diagnostics Inc. GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (XS/S/M/L/XL) 510(k) Number: K240545
4. Device Description:
The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.
5. Indications for Use:
The 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 glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).
Tested chemotherapy drugs and Fentanyl Citrate are as follows:
| Minimum Breakthrough Detection Time (Minutes) | ||
|---|---|---|
| Chemotherapy Drug and Concentration | Blue | Black |
| Carmustine, 3.3 mg/ml (3,300 ppm) | 14.7, Do not use | 22.6, Do not use |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
6
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
|---|---|---|
| Thiotepa, 10mg/ml (10,000ppm) | 36.4, Do not use | 35.6, Do not use |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time (Minutes) | |
|---|---|---|
| Blue | Black | |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 | >240 |
*Please note that the following drugs have low permeation times: Carmustine: 14.7 minutes, Thiotepa: 36.4 minutes (Blue); Carmustine: 22.6 minutes, Thiotepa: 35.6 minutes (Black) Warning: Do not use with Carmustine and Thiotepa.
Comparison of Subject Device and Predicate Device: 6.
| General Comparison Table | |||
|---|---|---|---|
| Items | Subject Device | Predicate Device | Comparison |
| K242936 | K240545 | Result | |
| Product Code | LZA, LZC, QDO,OPJ | LZA, LZC, QDO,OPJ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | 3 years | / | Different* |
| Material | Nitrile | Nitrile | Same |
| Available Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Different** |
| Rx or OTC | OTC | OTC | Same |
| Indications for Use | The 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 glove was tested for use with | |||
| chemotherapy drugs and Fentanyl | |||
| Citrate as per ASTM D6978-05(2023). | The GenaCheck™ Nitrile Powder Free | ||
| Examination Glove Tested for Use with | |||
| Chemotherapy Drugs and Fentanyl | |||
| Citrate is a specialty medical glove | |||
| which is a disposable device intended | |||
| for medical purpose that is worn on the | |||
| examiner's hand or finger to prevent | |||
| contamination between examiner and | |||
| patient. The glove was 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 | ||
| Powdered or Powder | |||
| free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue, Black | Purple | Different*** |
| Labeling Information | Single-use, powder free, device color, | ||
| device name, glove size and quantity, | |||
| Non-Sterile, Expiration date, a | |||
| statement of standard ASTM D6978 | |||
| compliance and a summary of the | |||
| testing results. | Single-use indication, powder free, | ||
| device color, device name, glove size | |||
| and quantity, Non-Sterile, a statement | |||
| of standard ASTM D6978 compliance | |||
| and a summary of the testing results. | Similar* | ||
| Chemotherapy Drugs | |||
| and Fentanyl Citrate | |||
| Claim | See below comparison table | See below comparison table | / |
7
Remarks:
- The subject device has been carried out the shelf life study according to the recognized standard ASTM D7160 and it can support the 3years shelf life of subject device, so the difference does not raise questions of safety and effectiveness.
** The subject device has Size XXL and meet the requirements of ASTM D6319. so the difference does not raise questions of safety and effectiveness.
*** The finished subject device has been tested with performance and Biocompatibility, all the the requirements, so the difference of color does not raise questions of safety and effectiveness.
| Technological Characteristics | Subject Device
K242936 | | Predicate Device
K240545 | Comparison
Result |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------|
| | Blue | Black | | |
| Length (mm) (Minimum) | Minimum 220 mm
(Sizes XS-S) Minimum
230 mm (sizes M-XXL)
Meet ASTM D6319 | Minimum 220 mm
(Sizes XS-S) Minimum
230 mm (sizes M-XXL)
Meet ASTM D6319 | Minimum 220 mm
(Sizes XS-S) Minimum
230 mm (sizes M - XL)
Meet ASTM D6319 | Similar* |
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | / | Different* |
| Finger | 0.05 | 0.05 | 0.05 | Same |
| Palm | 0.05 | 0.05 | 0.05 | Same |
| Tensile Strength,
Before Aging, min | 14MPa
Meet ASTM D6319 | 14MPa
Meet ASTM D6319 | 14MPa
Meet ASTM D6319 | Same |
| Ultimate Elongation,
Before Aging, min | 500%
Meet ASTM D6319 | 500%
Meet ASTM D6319 | 500%
Meet ASTM D6319 | Same |
| Tensile Strength,
After Accelerated Aging, min | 14MPa
Meet ASTM D6319 | 14MPa
Meet ASTM D6319 | 14MPa
Meet ASTM D6319 | Same |
| Ultimate Elongation,
After Accelerated Aging, min | 400%
Meet ASTM D6319 | 400%
Meet ASTM D6319 | 400%
Meet ASTM D6319 | Same |
| Freedom from holes | G-I, AQL 2.5
Meet ASTM D6319 | G-I, AQL 2.5
Meet ASTM D6319 | G-I, AQL 2.5
Meet ASTM D6319 | Same |
| Powder residual | ≤ 2 mg per glove
Meet ASTM D6319 | ≤ 2 mg per glove
Meet ASTM D6319 | ≤ 2 mg per glove
Meet ASTM D6319 | Same |
| In vitro Cytotoxicity
ISO 10993-5: 2009 | The test article extract
showed evidence of
causing severe cell lysis
or toxicity. Toxicity
concerns was addressed
by Acute Systemic
Toxicity testing. | The test article extract
showed evidence of
causing severe cell lysis
or toxicity. Toxicity
concerns was addressed
by Acute Systemic
Toxicity testing. | Under conditions of the
study, device extract is
cytotoxic. | Same |
| Acute Systemic Toxicity Test
ISO 10993-11: 2017 | There was no mortality
or evidence of systemic
toxicity from the
extracts injected into | There was no mortality
or evidence of systemic
toxicity from the
extracts injected into | Under the conditions of
the study, the test article
did not show acute
systemic toxicity in | Same |
| | mice. Each test article
extract met the
requirements of the
study. | mice. Each test article
extract met the
requirements of the
study. | vivo. | |
| Dermal Sensitization
ISO 10993-10: 2021 | The test article extracts
showed no evidence of
causing delayed dermal
contact sensitization in
the guinea pig. The test
article was not
considered a sensitizer
in the guinea pig
maximization test. | The test article extracts
showed no evidence of
causing delayed dermal
contact sensitization in
the guinea pig. The test
article was not
considered a sensitizer
in the guinea pig
maximization test. | Under the conditions of
the study, not a
sensitizer. | Same |
| Primary Skin Irritation
ISO 10993-23: 2021 | The test article met the
requirements of the test
since the difference
between each test article
extract overall mean
score and corresponding
control extract overall
mean score was 0.0 and
0.0 for the SC and SO
test article extracts,
respectively. | The test article met the
requirements of the test
since the difference
between each test article
extract overall mean
score and corresponding
control extract overall
mean score was 0.0 and
0.0 for the SC and SO
test article extracts,
respectively. | Under the conditions of
the study, not an
irritant. | Same |
Technological Characteristic Comparison Table
8
Remarks:
- The subject device has Size XXL and meet the requirements of ASTM D6319. so the difference does not raise questions of safety and effectiveness.
Chemotherapy Permeation and Fentanyl Citrate Comparison Table
| | Minimum Breakthrough Detection Time (BDT)
(Minutes) | | | |
|-----------------------------------------|--------------------------------------------------------|---------|-----------------------------|----------------------|
| Chemotherapy Drug and Concentration | Subject Device
K242936 | | Predicate Device
K240545 | Comparison
Result |
| | Blue | Black | | |
| Carmustine, 3.3 mg/ml (3,300 ppm) | 14.7 | 22.6 | 22.8 | Similar* |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 36.4 | 35.6 | 37.9 | Similar* |
| Mitomycin C, 0.5mg/ml (500 ppm) | No Test | No Test | >240 | Different** |
| Vincristine Sulfate, 1mg/ml (1,000 ppm) | No Test | No Test | >240 | Different** |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time (BDT)
(Minutes) | | Comparison
Result |
|------------------------------------|--------------------------------------------------------|-----------------------------|----------------------|
| | Subject Device
K242936 | Predicate Device
K240545 | |
9
| Blue | Black | |||
|---|---|---|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |
Remarks:
*The breakthrough detection times of Carmustine and Thiotepa of subject device are similar with that of the predicate device. The Chemotherapy Labeling Claims has clearly defined on the labeling and therefore it does not raise questions of safety and effectiveness.
** The information of Mitomycin C and Vincristine sulfate will not be labeling, so it does not raise questions of safety and effectiveness.
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19(2023) | To determine the length of the gloves | XS: $\geq$ 220 mm | |
| S: $\geq$ 220 mm | |||
| M: $\geq$ 230 mm | |||
| L: $\geq$ 230 mm | |||
| XL: $\geq$ 230 mm | |||
| XXL: $\geq$ 230 mm | Pass | ||
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Palm Width) | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL:120±10mm | |||
| XXL:130±10mm | Pass | ||
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Thickness) | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Pass | ||
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6319-19(2023) | |||
| ASTM D412-16(2021) | To determine the Physical Properties | Tensile Strength (Min14 MPa) and Elongation | |
| (Before Aging 500% and | |||
| after aging 400%) Min | Pass | ||
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6319-19(2023) | |||
| ASTM D5151-19(2023) | To determine the Water leak test | AQL 2.5 | Pass |
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6319-19(2023) | |||
| ASTM D6124-06 (2022) | To determine the Powder Residue | Max 2mg/glove | Pass |
| Meet the requirements of | |||
| ASTM D6319 | |||
| ASTM D6978-05 (2023) | chemical permeation testing | / | Refer to the above table |
| ISO 10993 Part 10-2021 | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. |
| ISO 10993 Part 23-2021 | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test article met the requirements of the test since the difference |
| between each test article | |||
| extract overall mean score | |||
| and corresponding control | |||
| extract overall mean score | |||
| was 0.0 and 0.0 for the SC | |||
| and SO test article extracts, | |||
| respectively | |||
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicity | |
| reactivity | The test article extract | ||
| showed evidence of | |||
| causing severe cell lysis or | |||
| toxicity. Toxicity concerns | |||
| was addressed by Acute | |||
| Systemic Toxicity testing. | |||
| ISO 10993-11:2017 | Acute systemic toxicity | ||
| study | Subject showed no | ||
| adverse biological | |||
| reaction | There was no mortality or | ||
| evidence of systemic | |||
| toxicity from the extracts | |||
| injected into mice. Each | |||
| test article extract met the | |||
| requirements of the study. |
10
- ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-19 (2023), Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (2022), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D412-16 (2021), Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
- . . . ASTM D6978-05 (2023), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization.
- . ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Irritation.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
8. Summary of Clinical Testing
Clinical testing is not needed for this device.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K240545.