(112 days)
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 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.
This FDA 510(k) summary describes the acceptance criteria and the study results for the Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology / Test | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19(2023) - Physical Dimensions | |||
| Length | To determine the length of the gloves | XS: $\geq$ 220 mmS: $\geq$ 220 mmM: $\geq$ 230 mmL: $\geq$ 230 mmXL: $\geq$ 230 mmXXL: $\geq$ 230 mm | Pass (Meet the requirements of ASTM D6319) |
| Palm Width | To determine the Physical Dimensions (Palm Width) | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL:120±10mmXXL:130±10mm | Pass (Meet the requirements of ASTM D6319) |
| Thickness | 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) - Physical Properties | |||
| Tensile Strength, Before Aging | To determine the Physical Properties | 14MPa (Min) | Pass (Meet the requirements of ASTM D6319) |
| Ultimate Elongation, Before Aging | To determine the Physical Properties | 500% (Min) | Pass (Meet the requirements of ASTM D6319) |
| Tensile Strength, After Accelerated Aging | To determine the Physical Properties | 14MPa (Min) | Pass (Meet the requirements of ASTM D6319) |
| Ultimate Elongation, After Accelerated Aging | To determine the Physical Properties | 400% (Min) | Pass (Meet the requirements of ASTM D6319) |
| ASTM D6319-19(2023) & ASTM D5151-19(2023) - Freedom From Holes | |||
| Water leak test | To determine the Water leak test | AQL 2.5 | Pass (Meet the requirements of ASTM D6319) |
| ASTM D6319-19(2023) & ASTM D6124-06 (2022) - Powder Residue | |||
| Powder Residue | To determine the Powder Residue | Max 2mg/glove | Pass (Meet the requirements of ASTM D6319) |
| ASTM D6978-05 (2023) - Chemical Permeation | No specific numerical acceptance criteria listed in the table, but the general expectation is to meet or be comparable to predicate for safe use. The drug-specific breakthrough detection times (BDT) are considered the performance metric. | Blue Gloves: Carmustine: 14.7 min Cisplatin: >240 min Cyclophosphamide: >240 min Dacarbazine: >240 min Doxorubicin HCL: >240 min Etoposide: >240 min Fluorouracil: >240 min Methotrexate: >240 min Paclitaxel: >240 min Thiotepa: 36.4 min Fentanyl Citrate: >240 min Black Gloves: Carmustine: 22.6 min Cisplatin: >240 min Cyclophosphamide: >240 min Dacarbazine: >240 min Doxorubicin HCL: >240 min Etoposide: >240 min Fluorouracil: >240 min Methotrexate: >240 min Paclitaxel: >240 min Thiotepa: 35.6 min Fentanyl Citrate: >240 min | |
| ISO 10993 Part 10-2021 - Biocompatibility | |||
| Skin Sensitization Testing | 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 - Biocompatibility | |||
| Skin Irritation Testing | 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 - Biocompatibility | |||
| Cytotoxicity testing | Cytotoxicity testing | No Cytotoxicity reactivity (note: text says "No Cytotoxicity reactivity" but result section shows some initial toxicity addressed by further testing) | 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 - Biocompatibility | |||
| Acute systemic toxicity study | 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. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the test sets for each specific test (e.g., how many gloves were tested for length, how many for water leak). However, the standard ASTM D6319-19(2023) and other listed standards would define the required sample sizes for each test to ensure statistical validity.
The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective. However, the tests are "non-clinical tests" conducted to verify design specifications and conform to international and national standards (ASTM, ISO). This suggests the data was generated through controlled laboratory testing following these specified methodologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a medical glove, and its performance evaluation primarily relies on objective, standardized laboratory tests against defined physical, chemical, and biological endpoints, not subjective expert assessment of images or clinical cases. Therefore, the concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies does not apply here. The "ground truth" for these tests is the quantitative measurement results compared to the established thresholds defined by the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As mentioned above, the evaluation relies on objective analytical tests rather than subjective human assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of these gloves is based on objective measurements and chemical analysis as defined by the referenced ASTM and ISO standards. For example:
- Physical properties (length, width, thickness, tensile strength, elongation): Measured values compared to a numerical range or minimum defined by ASTM D6319.
- Freedom from holes (water leak test): Objective criteria (AQL 2.5) for defect detection.
- Powder residue: Quantitative measurement (Max 2mg/glove).
- Chemical permeation (chemotherapy drugs and Fentanyl Citrate): Directly measured breakthrough detection time (BDT) in minutes, as per ASTM D6978.
- Biocompatibility (Sensitization, Irritation, Cytotoxicity, Systemic Toxicity): Laboratory test results demonstrating lack of adverse biological reactions as defined by ISO 10993 standards and evaluated against established pass/fail criteria (e.g., no evidence of sensitization, no irritancy, no mortality/toxicity).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
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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
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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.
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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 deviceintended for medical purposes that isworn on the examiner's hand or fingerto prevent contamination betweenpatient and examiner.The glove was tested for use withchemotherapy drugs and FentanylCitrate as per ASTM D6978-05(2023). | The GenaCheck™ Nitrile Powder FreeExamination Glove Tested for Use withChemotherapy Drugs and FentanylCitrate is a specialty medical glovewhich is a disposable device intendedfor medical purpose that is worn on theexaminer's hand or finger to preventcontamination between examiner andpatient. The glove was tested for usewith Chemotherapy Drugs and FentanylCitrate as per ASTM D6978-05Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs. | Same |
| Powdered or Powderfree | 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, astatement of standard ASTM D6978compliance and a summary of thetesting results. | Single-use indication, powder free,device color, device name, glove sizeand quantity, Non-Sterile, a statementof standard ASTM D6978 complianceand a summary of the testing results. | Similar* |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | / |
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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 DeviceK242936 | Predicate DeviceK240545 | ComparisonResult | |
|---|---|---|---|---|
| Blue | Black | |||
| Length (mm) (Minimum) | Minimum 220 mm(Sizes XS-S) Minimum230 mm (sizes M-XXL)Meet ASTM D6319 | Minimum 220 mm(Sizes XS-S) Minimum230 mm (sizes M-XXL)Meet ASTM D6319 | Minimum 220 mm(Sizes XS-S) Minimum230 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 | 14MPaMeet ASTM D6319 | 14MPaMeet ASTM D6319 | 14MPaMeet 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 | 14MPaMeet ASTM D6319 | 14MPaMeet ASTM D6319 | 14MPaMeet 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 2.5Meet ASTM D6319 | G-I, AQL 2.5Meet ASTM D6319 | G-I, AQL 2.5Meet ASTM D6319 | Same |
| Powder residual | ≤ 2 mg per gloveMeet ASTM D6319 | ≤ 2 mg per gloveMeet ASTM D6319 | ≤ 2 mg per gloveMeet ASTM D6319 | Same |
| In vitro CytotoxicityISO 10993-5: 2009 | The test article extractshowed evidence ofcausing severe cell lysisor toxicity. Toxicityconcerns was addressedby Acute SystemicToxicity testing. | The test article extractshowed evidence ofcausing severe cell lysisor toxicity. Toxicityconcerns was addressedby Acute SystemicToxicity testing. | Under conditions of thestudy, device extract iscytotoxic. | Same |
| Acute Systemic Toxicity TestISO 10993-11: 2017 | There was no mortalityor evidence of systemictoxicity from theextracts injected into | There was no mortalityor evidence of systemictoxicity from theextracts injected into | Under the conditions ofthe study, the test articledid not show acutesystemic toxicity in | Same |
| mice. Each test articleextract met therequirements of thestudy. | mice. Each test articleextract met therequirements of thestudy. | vivo. | ||
| Dermal SensitizationISO 10993-10: 2021 | The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization inthe guinea pig. The testarticle was notconsidered a sensitizerin the guinea pigmaximization test. | The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization inthe guinea pig. The testarticle was notconsidered a sensitizerin the guinea pigmaximization test. | Under the conditions ofthe study, not asensitizer. | Same |
| Primary Skin IrritationISO 10993-23: 2021 | The test article met therequirements of the testsince the differencebetween each test articleextract overall meanscore and correspondingcontrol extract overallmean score was 0.0 and0.0 for the SC and SOtest article extracts,respectively. | The test article met therequirements of the testsince the differencebetween each test articleextract overall meanscore and correspondingcontrol extract overallmean score was 0.0 and0.0 for the SC and SOtest article extracts,respectively. | Under the conditions ofthe study, not anirritant. | Same |
Technological Characteristic Comparison Table
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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 DeviceK242936 | Predicate DeviceK240545 | ComparisonResult | |
| 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) | ComparisonResult | |
|---|---|---|---|
| Subject DeviceK242936 | Predicate DeviceK240545 |
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| 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 mmS: $\geq$ 220 mmM: $\geq$ 230 mmL: $\geq$ 230 mmXL: $\geq$ 230 mmXXL: $\geq$ 230 mm | PassMeet the requirements ofASTM D6319 |
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Palm Width) | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL:120±10mmXXL:130±10mm | PassMeet the requirements ofASTM D6319 |
| ASTM D6319-19(2023) | To determine the Physical Dimensions (Thickness) | Finger: 0.05mm (min)Palm: 0.05mm (min) | PassMeet the requirements ofASTM D6319 |
| ASTM D6319-19(2023)ASTM D412-16(2021) | To determine the Physical Properties | Tensile Strength (Min14 MPa) and Elongation(Before Aging 500% andafter aging 400%) Min | PassMeet the requirements ofASTM D6319 |
| ASTM D6319-19(2023)ASTM D5151-19(2023) | To determine the Water leak test | AQL 2.5 | PassMeet the requirements ofASTM D6319 |
| ASTM D6319-19(2023)ASTM D6124-06 (2022) | To determine the Powder Residue | Max 2mg/glove | PassMeet the requirements ofASTM 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 articleextract overall mean scoreand corresponding controlextract overall mean scorewas 0.0 and 0.0 for the SCand SO test article extracts,respectively | |||
| ISO 10993-5:2009 | Cytotoxicity testing | No Cytotoxicityreactivity | The test article extractshowed evidence ofcausing severe cell lysis ortoxicity. Toxicity concernswas addressed by AcuteSystemic Toxicity testing. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed noadverse biologicalreaction | There was no mortality orevidence of systemictoxicity from the extractsinjected into mice. Eachtest article extract met therequirements of the study. |
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- 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.
§ 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.