(83 days)
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
It appears there's a misunderstanding regarding the provided document. The request asks for details about the acceptance criteria and study proving a device meets these criteria, specifically in the context of an AI/ML medical device.
However, the provided text is an FDA 510(k) clearance letter and related documentation for Powder-Free Frost Nitrile Examination Gloves. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through physical and chemical performance tests, and biocompatibility, as applicable to examination gloves.
This document does NOT describe an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment, training set size) are not applicable to the content provided.
Instead, the document details the acceptance criteria and study results for the nitrile examination gloves. Here's a breakdown based on the provided text, focusing on the relevant criteria for gloves:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria (for Nitrile Examination Gloves) | Reported Device Performance |
|---|---|
| Physical Dimensions | |
| Length: Min 220 mm (Small), Min 230 mm (others) | Met Standard |
| Width: S: 80+/-10 mm, M: 95+/-10 mm, L: 110+/-10 mm, XL: 115+/-10 mm | Met Standard |
| Palm Thickness: 0.05 mm min (all sizes) | Met Standard |
| Finger Thickness: 0.05 mm min (all sizes) | Met Standard |
| Physical Properties (ASTM D412) | |
| Tensile Strength (Before Aging): 14 MPa, min | $\ge$ 14 MPa (Reported 19.0 min MPa) |
| Ultimate Elongation (Before Aging): 500 % min | 500% (Reported 610 min %) |
| Tensile Strength (After Aging): 14 MPa, min | $\ge$ 14 MPa (Reported 22.6 min MPa) |
| Ultimate Elongation (After Aging): 400 % min | 400% (Reported 486 min %) |
| Integrity | |
| Detection of Holes (ASTM D5151-2019): AQL 2.5 | Meets requirement (AQL = 2.5) |
| Residual Powder (ASTM D6124-06): $\le$ 2.0 mg/glove | 0.54 mg/Glove |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |
| Carmustine (3.3 mg/ml): Breakthrough Detection Time | 16.2 min (Note: Lower than predicate, addressed by labeling warning) |
| Cisplatin (1 mg/ml): Breakthrough Detection Time | >240 min. |
| Cyclophosphamide (20 mg/ml): Breakthrough Detection Time | >240 min. |
| Dacarbazine (10 mg/ml): Breakthrough Detection Time | >240 min. |
| Doxorubicin HCL (2 mg/ml): Breakthrough Detection Time | >240 min. |
| Etoposide (20 mg/ml): Breakthrough Detection Time | >240 min. |
| Fluorouracil (50 mg/ml): Breakthrough Detection Time | >240 min. |
| Mitomycin C (0.5 mg/ml): Breakthrough Detection Time | >240 min. |
| Paclitaxel (60 mg/ml): Breakthrough Detection Time | >240 min. |
| Thiotepa (10 mg/ml): Breakthrough Detection Time | 40.6 min (Note: Lower than predicate, addressed by labeling warning) |
| Vincristine Sulfate (1 mg/ml): Breakthrough Detection Time | >240 min. |
| Fentanyl/Citrate Injection (100mcg/2mL): Breakthrough Detection Time | >240 min. |
| Biocompatibility | |
| Skin Sensitization (ISO 10993-10:2010) | Pass (Non-Sensitizer) |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Pass (Non-Irritant) |
| In vitro Cytotoxicity (ISO 10993-5:2009) | Considered Cytotoxic (Note: This is an observation, not necessarily a failure from a regulatory standpoint if mitigated or typical for the material) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass |
Study Details (for Nitrile Examination Gloves - as provided by the document):
-
Sample sizes used for the test set and the data provenance: The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, how many for elongation, etc.), nor does it specify the country of origin of the data. The tests are bench tests performed on the product itself. The data provenance is implied to be laboratory testing conducted to support the 510(k) submission. It's retrospective in the sense that the tests were completed before the submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For physical and chemical tests of medical examination gloves, "ground truth" is established by the standardized test methods themselves (e.g., ASTM standards) and objective measurements by trained laboratory personnel, not by human expert interpretation in the way it would be for an AI device.
-
Adjudication method for the test set: Not applicable. Results are objective measurements against defined standards.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human reader performance, typically in diagnostic imaging, with and without AI assistance. The submitted device is a physical product (gloves).
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm/AI device. The "standalone" performance here refers to the glove's inherent physical and chemical properties as tested against standards.
-
The type of ground truth used:
- For physical and performance characteristics (length, width, thickness, tensile strength, elongation, hole detection, residual powder), the ground truth is established by objective measurements and performance against predefined industry standards (e.g., ASTM D6319-19, ASTM D412, ASTM D5151, ASTM D6124).
- For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.
- For biocompatibility, the ground truth is determined by standardized biological assays (e.g., ISO 10993 series) with specified endpoints (e.g., non-sensitizer, non-irritant, non-cytotoxic, no systemic toxicity concern).
-
The sample size for the training set: Not applicable. This device is not an AI/ML model, so there is no "training set."
-
How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
October 2, 2023
Isikel Manufacturing LLC % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K232064
Trade/Device Name: Powder-Free Frost Nitrile Examination Gloves (Blue) (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, OPJ, QDO Dated: July 10, 2023 Received: July 11, 2023
Dear Yolanda Smith:
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/cdrb/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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.
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).
Sincerely.
Allan Gu
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232064
Device Name
Powder-Free Frost Nittile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate)
Indications for Use (Describe)
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration |
|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) |
| Cisplatin | 1 mg/ml (1,000 ppm) |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) |
| Dacarbazine | 10 mg/ml (10,000 ppm) |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) |
| Etoposide | 20 mg/ml (20,000 ppm) |
| Fluorouracil | 50 mg/ml (50,000 ppm) |
| Mitomycin C | 0.5 mg/ml (500 ppm) |
| Paclitaxel | 60 mg/ml (6,000 ppm) |
| Thiotepa | 10 mg/ml (10,000 ppm) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) |
| Fentanyl/Citrate Injection | 100 mcg/2mL |
Breakthrough Detection Time 16.2 (16.2,21.6,21.9) min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. 40.6 (70.6,40.6,40.6) min. >240 min. >240min.
Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 minutes 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)
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| Submitter's Information | |
|---|---|
| Company: | Isikel Manufacturing LLC. |
| Address: | 28350 West Ten Blvd.Katy, TX 77494 |
| Phone: | 832-523-2027 |
| Contact: | Christopher Betts |
| Email: | chris.betts@isikelmfg.com |
| Date Prepared: | October 2, 2023 |
| Designated Submission Correspondent | |
|---|---|
| Name | Yolanda Smith |
| Company: | Smith Associates |
| Address: | 1468 Harwell AvenueCrofton, MD 21114 |
| Phone | 888-729-9674 x 203 |
| Email: | ysmith@fdaconsultants.com |
| Email: | ysmith@fdaconsultants.com |
|---|---|
| Device Information and Name | |
| Trade Name: | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
| Common Name: | Patient Examination Gloves, Specialty |
| Classification Name: | Polymer Patient Exam Glove, Medical Gloves with Chemotherapy Labeling Claims |
| Product Code: | LZA- Polymer Patient Examination Glove |
| Product Code: | LZC- Patient Examination Glove, Specialty |
| Product Code: | OPJ- Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Product Code | QDO - Fentanyl And Other Opioid Protection Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I, Reserved |
| Reviewing Panel: | General Hospital |
| Basis for Submission: | New Device 510(k) |
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| Predicate Device K211810 | |
|---|---|
| Manufacturer | PT. Shamrock Manufacturing Corporation |
| Device Name | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested foruse with Chemotherapy Drugs and Fentanyl Citrate) |
| Regulation No.Regulation Name | 21 CFR 880.6250Non-Powdered Patient Examination Glove |
| 510 (K) Number | K211810 |
| Regulatory Class | 1 |
| Product Code | LZA, LZC, OPJ, QDO |
1. Device Description
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
2. Indications for Use
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
| Tested Chemotherapy DrugName | Concentration | Breakthrough Detection Time |
|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | 16.2 (16.2.21.6,21.9) min. |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
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| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
|---|---|---|
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. |
| Paclitaxel | 60 mg/ml (6,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 40.6 (70.6,40.6,40.6) min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Fentanyl/Citrate Injection | 100mcg / 2mL | >240 min. |
Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 Minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 Minutes Warning: Do Not Use with Carmustine and Thiotepa
| Characteristics | Subject Device | Predicate DeviceK211810 | Comparison |
|---|---|---|---|
| K Number | K211810 | ||
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Indications for use | Powder-Free Frost NitrileExamination Gloves (Blue)(Tested for use withChemotherapy Drugs andFentanyl Citrate) is adisposable device intended formedical purposes that is wornon the examiner's hands toprevent contaminationbetween patient and examiner.In addition, these gloves weretested for use withChemotherapy drugs andFentanyl Citrate inaccordance with ASTMD6978-05Carmustine 3.3 mg/ml (3,300ppm)16.2 (16.2.21.6,21.9) min.Cisplatin1 mg/ml (1,000 ppm)>240 min. | A patient examination gloveis a disposable deviceintended for medical purposethat is worn on examiner'shand toprevent contaminationbetween patient andexaminer. These gloves weretested for use withChemotherapy Drugs as perASTM D6978-05(2019)Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs andFentanyl. The followingchemicals have been testedwith these gloves:Chemotherapy Drug andConcentration BreakthroughDetection Time in MinutesCarboplatin (Paraplatin), 10mg/ml (10,000ppm) > 240min. | Same forindicationsfor usestatement andfor allcomparativechemotherapydrugs. |
| Characteristics | Subject Device | Predicate DeviceK211810 | Comparison |
| Cyclophosphamide 20mg/ml (20,000 ppm)>240 min.Dacarbazine 10 mg/ml(10,000 ppm)>240 min.Doxorubicin HCL 2 mg/ml(2,000 ppm)>240 min.Etoposide 20 mg/ml (20,000ppm)>240 min.Fluorouracil 50 mg/ml(50,000 ppm)>240 min.Mitomycin C 0.5 mg/ml (500ppm)>240 min.Paclitaxel 60 mg/ml (6,000ppm)>240 min.Thiotepa 10 mg/ml (10,000ppm)40.6 (70.6,40.6,40.6) min.Vincristine Sulfate 1 mg/ml(1,000 ppm)>240 min.Fentanyl/Citrate Injection100mcg / 2mL >240 min.Please note the followingdrugs have low permeationtimes:Carmustine 3.3 mg/ml (3,300ppm) 16.2(16.2.21.6,21.9)MinutesThiotepa 10 mg/ml (10,000ppm) 40.6 (70.6,40.6,40.6)MinutesWarning: Do Not Use withCarmustine and Thiotepa | Carmustine (BCNU), 3.3mg/ml (3,300ppm) 46.6 min.Chloroquine 50mg/ml(50,000ppm) > 240 minCisplatin, 1.0 mg/ml(1,000ppm) > 240 minCyclophosphamide(Cytoxan), 20.0mg/ml(20,000 ppm) > 240 minDacarbazine, 10.0mg/ml(10,000ppm) > 240 minDocetaxel, 10mg/ml(10,000ppm) > 240 minDoxorubicin HCI, 2.0mg/ml(2,000ppm) > 240 minEtoposide, 20.0mg/ml(20,000ppm) > 240 minFluorouracil, 50.0mg/ml(50,000ppm) > 240 minIfosfamide, 50 mg/ml (50,000ppm) > 240 minMethotrexate, 25mg/ml(25,000 ppm) > 240 minMitomycin C, 0.5 mg/ml (500ppm) > 240 minPaclitaxel, 6.0 mg/ml (6,000ppm) > 240 minThiotepa, 10.0mg/ml(10,000ppm) 64.8 minVincristine Sulfate, 1 mg/ml(1,000 ppm) > 240 minFentanyl Citrate Injection100mcg/2ml (50mcg/1ml) >240 minPlease note that the followingdrugs that have lowpermeation time are:Carmustine (BCNU), 3.3mg/ml 46.6 minThiotepa, 10.0mg/ml 64.8minCAUTION: Testing showedan average of breakthroughtime of 46.6 min forCarmustine and 64.8 min forThiotepa. | ||
| Powdered or Powderfree | Powder free | Powder free | Same |
| Material | Nitrile | Nitrile | Same |
| Characteristics | Subject Device | Predicate DeviceK211810 | Comparison |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Color | Light Blue | Blue | Similar |
| Size | Small, Medium, Large, ExtraLarge | X-Small, Small, Medium,Large, X-Large, XX-large | Similar |
| Single Use vsReusable | Single use | Single use | Same |
| Residual Powder | Powder Free<=2 mg/gloveComplies with ASTM D6319-19 | Powder Free<=2 mg/gloveComplies with ASTM D6319-19 | Same |
| Detection of HolesASTM D5151-2019 | AQL 2.5Complies with ASTM D6319-19 | AQL 2.5Complies with ASTM D6319-19 | Same |
| Dimensions(Length, Width,Thickness) | Complies with ASTM D6319-19 | Complies with ASTM D6319-19 | Same |
| Physical Properties(Unaged) | Elongation: 500% min.Tensile Strength: 14MPa min.Complies with ASTM D6319-19 | Elongation: 500% min.Tensile Strength: 14MPa min.Complies with ASTMD6319-19 | Same |
| Physical Properties(Aged) | Elongation: 400% min.Tensile Strength: 14MPa min.Complies with ASTM D6319-19 | Elongation: 400% min.Tensile Strength: 14MPa min.Complies with ASTMD6319-19 | Same |
| LabelingInformationFDA LabelRequirements | Meets FDA's Requirements | Meets FDA's Requirements | Same |
3. Summary of the Technological Characteristics of the Device compared to its Predicate
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| Test Method | ASTM D6319-19 | Comparison ofTest results | |||||
|---|---|---|---|---|---|---|---|
| Purpose | To Determine the Length of Gloves | ||||||
| Acceptance Criteria | Min 220 mm for all Size Small & Min 230 mm for all other sizes | ||||||
| Designation-Length | S | M | L | XL | Tolerance | ||
| SubjectDevice | Length, mm | 220mm | 230mm | 230mm | 230mm | min. | Met Standard |
| PredicateK211810 | Length, mm | 220mm | 230mm | 230mm | 230mm | min. | Met Standard |
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| Test Method | ASTM D6319-19 | Comparison of Test results | |||||
|---|---|---|---|---|---|---|---|
| Purpose | To Determine the Width of Gloves | ||||||
| Acceptance Criteria | Small: 80+/110 mmMedium: 95+/- 10mmLarge: 110+/- 10mmX Large: 115+/1 10mm | ||||||
| Designation- Width | S | M | L | XL | Tolerance | ||
| Subject Device | Width, mm | 80mm | 95mm | 110mm | 115mm | $\u00b1$ 10 | Met Standard |
| Predicate K211810 | Width, mm | 80mm | 95mm | 110mm | 115mm | $\u00b1$ 10 | Met Standard |
| Test Method | ASTM D6319-2019 | Comparison of Test results | ||||
|---|---|---|---|---|---|---|
| Purpose | To Determine the Palm Thickness of the Glove | |||||
| Acceptance Criteria | Palm 0.05 mm min for all sizes | |||||
| Designation- Palm | S | M | L | XL | ||
| Subject | Palm | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| PredicateK211810 | Palm | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Purpose | To Determine the Finger Thickness of the Glove | |||||
| Acceptance Criteria | Finger 0.05 mm min for all sizes | |||||
| Designation - Finger | S | M | L | XL | ||
| Subject | Finger | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| PredicateK211810 | Finger | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Test Method | ASTM D412 | Comparison of Test results | |
|---|---|---|---|
| Purpose | Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension | ||
| Acceptance CriteriaBefore Aging | Tensile Strength- Before Aging14 MPa, min | Ultimate Elongation- Before Aging500 % min | |
| Subject | $\geq$ 14 MPa | 500% | Same |
| Predicate | $\geq$ 14 MPa | 500% | Same |
| K211810 | |||
| Test Method | ASTM D412 | Comparison of Test results |
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| Purpose | Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension | ||
|---|---|---|---|
| Acceptance CriteriaAfter Aging | Tensile Strength- After Aging14 MPa, min | Ultimate Elongation- After Aging400% min | |
| Subject | $\u2265$ 14 MPa | 400% | Same |
| PredicateK211810 | $\u2265$ 14 MPa | 400% | Same |
| Tested ChemotherapyDrug Name | Concentration | Subject Device | Predicate Device211810 | Comparison |
|---|---|---|---|---|
| Carmustine | 3.3 mg/ml(3,300 ppm) | 16.2 min(16.2. 21.6,21.9) | 46.6 Minutes | Different |
| Cisplatin | 1 mg/ml (1,000ppm) | >240 min. | >240 Minutes | Same |
| Cyclophosphamide | 20 mg/ml(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 min. | >240 Minutes | Same |
| Doxorubicin HCL | 2 mg/ml (2,000ppm) | >240 min. | >240 Minutes | Same |
| Etoposide | 20 mg/ml(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Fluorouracil | 50 mg/ml(50,000 ppm) | >240 min. | >240 Minutes | Same |
| Mitomycin C | 0.5 mg/ml (500ppm) | >240 min. | >240 Minutes | Same |
| Paclitaxel | 60 mg/ml (6,000ppm) | >240 min. | >240 Minutes | Same |
| Thiotepa | 10 mg/ml(10,000 ppm) | 40.6 min(70.6,40.6,40.6) | 64.8 Minutes | Different |
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | >240 min. | >240 Minutes | Same |
| Fentanyl/CitrateInjection | 100mcg / 2mL | >240 min. | >240 Minutes | Same |
| Test Method | Purpose of Test | Subject Device | Predicate | Comparison of Test results |
|---|---|---|---|---|
| ASTM D6319-19 | Physical DimensionsTo determine the Lengthand Width of Gloves | Complies with: ASTM D6319-19 | Complies with:ASTM D6319-19 | Same |
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| TestMethod | Purpose of Test | Subject Device | Predicate | Comparisonof Test results |
|---|---|---|---|---|
| ASTMD5151 | Watertightness Test forDetection of Holes | Meets the requirementwhen tested inaccordance withASTM D5151AQL = 2.5 | Complies with:ASTM D6319-19 ASTMD5151AQL 2.5 | Same |
| ASTMD6124-06 | To determine the residualpowder in gloves | Meets the requirementof ASTM D6124 $<$ 2mg glove | Complies with:ASTM D6319-19$<$ 2 mg perglove | Same |
| Test Performed | Subject Device | Predicate DeviceK211820 | Comparison |
|---|---|---|---|
| ISO 10993-10:2010Skin Sensitization Test | Non-Sensitizer | Under the conditionsof study, not asensitizer | Same |
| ISO 10993-23:2021Intracutaneous Reactivity Test | Non-Irritant | Under the conditionsof study, not anirritant | Same |
| ISO 10993-5:2009In vitro Cytotoxicity Test | Under theconditions of thestudy, cytotoxic. | Under theconditions of thestudy, cytotoxic | Same |
| ISO 10993-11:2017Acute Systemic Toxicity Test | Pass | Under the conditionsof study, does notinduce any acutesystemictoxicity concern | Same |
Analysis: Some of the sizes are different with that of the predicate, but they all meet the requirements of ASTM D6319-19. The differences do not raise any new safety or performance issues. Differences in breakthrough detection times are addressed through labeling.
4. Discussion of Non-Clinical Performance Testing
Non-Clinical test were conducted to verify that the proposed device met all design specifications.
Biocompatibility Testing
ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices. Part 10- Test for Irritation and Skin Sensitization.
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ISO 10993-11 ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ISO 10993-23:2021 Biological Evaluation of Medical Devices, Part 23: Tests for Irritation-Primary
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the label claim: Tested for use with Chemotherapy drugs and Fentany] Citrate. The proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted in accordance with the following test methods:
- ASTM D6319-19 Standard Specifications for Nitrile Examination Gloves for Medical Application.
- o ASTM D412-Test methods for Vulcanized Rubber and Thermoplastic Elastomers- Tension.
- o ASTM D573-Test Method for Rubber-Deterioration in an Air Oven.
- o ASTM D3767- Practice Rubber Examination Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical о Gloves
- 0 ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6978-05- Standard Practice for Assessment of Resistance of Medical Gloves to . Permeations by Chemotherapy Drugs.
| Physical Properties -Tensile StrengthBefore and After Aging | Acceptance Criteria- For all SizesBefore and After Aging 14Mpa | ||
|---|---|---|---|
| Test Method - Applicable Standard | Before Aging | After Aging | UnexpectedResults –SignificantDeviations |
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| ASTM D412 | 19.0 min (MPa) | 22.6 min(MPa) | None |
|---|---|---|---|
| Physical Properties-Ultimate ElongationBefore and After AgingAcceptance Criteria- For All SizesBefore Aging 500% - After Aging 400% | |||
| Test Method - Applicable Standard | Before Aging | After Aging | UnexpectedResults –SignificantDeviations |
| ASTM D573 | 610 min(%) | 486 min(%) | None |
| Test Method | ASTM D6319-19 | f Test results | |||||
|---|---|---|---|---|---|---|---|
| Purpose | To Determine the Length of Gloves | ||||||
| Acceptance Criteria | Min 220 mm for all Size Small & Min 230 mm for all other sizes | ||||||
| Designation-Length | S | M | L | XL | Tolerance | ||
| Subject Device | Length, mm | 220mm | 230mm | 230mm | 230mm | min. | Met Standard |
| Test Method | ASTM D6319-19 | Comparison of Test results | |||||
| Purpose | To Determine the Width of Gloves | ||||||
| Acceptance Criteria | Small: 80+/110 mmMedium: 95+/- 10mmLarge: 110+/- 10mmX Large: 115+/1 10mm | ||||||
| Designation- Width | S | M | L | XL | Tolerance | ||
| Subject Device | Width, mm | 80mm | 95mm | 110mm | 115mm | $\pm$ 10 | Met Standard |
| Test Method | ASTM D6319-2019 | Test Results | ||||
|---|---|---|---|---|---|---|
| Purpose | To Determine the Palm Thickness of the Glove | |||||
| Acceptance Criteria | Palm 0.05 mm min for all sizes | |||||
| Designation- Palm | S | M | L | XL | ||
| Subject | Palm | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | 0.05 mm min. | Meets standard |
| Purpose | To Determine the Finger Thickness of the Glove | |||||
| Acceptance Criteria | Finger 0.05 mm min for all sizes | |||||
| Designation - Finger | S | M | L | XL |
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| Aniec | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Car and Career Company | ﺑﮭﺎﺭﺕstandard | ||
|---|---|---|---|---|---|
| 111111- | min | 111111 | 111111 |
| Test Performed | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Residual Powder onMedical Gloves | ASTM D6124-06 | Limit: ≤ 2.0 mg | 0.54 mg/Glove |
| Chemotherapy Drug | Concentration | Breakthrough TimeIn Minutes | Observations |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm | 16.2 (16.2.21.6,21.9) | Slight swelling and no degradation |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. | Slight swelling and no degradation |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | Slight swelling and no degradation |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | Slight swelling and no degradation |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | Slight swelling and no degradation |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | Slight swelling and no degradation |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | Slight swelling and no degradation |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. | Slight swelling and no degradation |
| Paclitaxel | 60 mg/ml (6,000 ppm) | >240 min. | Slight swelling and no degradation |
| Thiotepa | 10 mg/ml (10,000 ppm) | 40.6 min | Slight swelling and no degradation |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | Slight swelling and no degradation |
| Fentanyl/CitrateInjection | 100mcg / 2mL | >240 Minutes | Slight swelling and degradation |
| Test Performed | Acceptance Criteria | Results |
|---|---|---|
| ISO 10993-10:2010Skin Sensitization Test | Under the conditions of thestudy, not a sensitizer | Pass (Non- Sensitizer) |
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| Test Performed | Acceptance Criteria | Results |
|---|---|---|
| ISO 10993-23:2021Intracutaneous Reactivity Test | Under the conditions of thestudy, not an irritant | Pass (Non-Irritant) |
| ISO 10993-5:2009In vitro Cytotoxicity Test | Under the conditions of thestudy, non-cytotoxic | Was consideredCytotoxic |
| ISO 10993-11:2017Acute Systemic Toxicity Test | Under the conditions of thestudy, the device extracts do notpose an acute systemic toxicityconcern. | Pass |
5. Discussion of Clinical Testing
Clinical testing is not needed for this device.
6. Conclusion
The conclusions from the non-clinical tests demonstrate that the Powder-Free Frost Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the predicate device that was cleared under K211280.
§ 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.