(111 days)
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.
Warning: Not for use with Carmustine, Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile, powder-free, textured, ambidextrous, non-sterile patient examination glove that is packed in a cardboard dispenser box.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Halyard Black Nitrile Powder-Free Exam Gloves.
Based on the provided K242558 510(k) summary, the device is a medical glove, and the studies performed are non-clinical, primarily focused on physical properties, biocompatibility, and resistance to chemical permeation. This is not a study assessing AI performance or human reader effectiveness.
Acceptance Criteria and Reported Device Performance
| Test Method | Standard | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Dimensions | ASTM D6319 | Length: ≥230 mm | PASS |
| Palm Width Size: X-Small: 60 – 80 mm; Small: 70 - 90 mm; Med: 85–105 mm; Large: 100 - 120 mm; X-Large: 110-130 mm; XX-Large: 120-140 mm | PASS | ||
| Finger thickness: ≥0.05 mm | PASS | ||
| Palm thickness: ≥0.05 mm | PASS | ||
| Cuff thickness: ≥0.05 mm | PASS | ||
| Physical Properties | ASTM D6319 | AQL 4.0; Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%; After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | PASS |
| Freedom from Pinholes | ASTM D6319, ASTM D5151 | AQL 2.5%; No leakage | PASS |
| Residual Powder | ASTM D6124, ASTM D6319 | ≤ 2 mg / glove | PASS |
| Permeation by Chemotherapy Drugs | ASTM D6978 | No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCl (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Mitoxantrone HCl (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml). Caution (Breakthrough < 60 min): Carmustine (3.3 mg/ml – no breakthrough up to 35.1 minutes). Caution (Breakthrough < 120 min): Thiotepa (10 mg/ml – no breakthrough up to 107.2 minutes). Warning: Not for use with Carmustine, Thiotepa. | PASS |
| Permeation by Hazardous Drugs (Opioids) | ASTM D6978 (Implied) | No breakthrough detected up to 240 minutes for: Fentanyl Citrate Injection (50 mcg/5 ml), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. | PASS |
| Test for Irritation | ISO 10993, Part 23 | No dermal irritation reactions | PASS |
| Test for Acute Systemic Toxicity | ISO 10993, Part 11 | Under the conditions of the study, the device extract does not induce acute systemic toxicity response. | PASS |
| Test for Skin Sensitization | ISO 10993, Part 10 | No dermal reactions indicative of delayed contact hypersensitivity. | PASS |
Study Details (Based on available information)
-
Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for pinholes, number of samples per drug for permeation). However, all tests are performed according to recognized ASTM and ISO standards, which typically specify statistically significant sample sizes for their respective tests.
- Data Provenance: The studies are non-clinical (laboratory-based) performance and biocompatibility tests conducted by the manufacturer (O&M Halyard, Inc.). The country of origin of the data is not specified but is implicitly associated with the manufacturer's testing facilities. The studies are prospective in nature, meaning they were designed and executed to evaluate the device's performance against defined criteria.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-clinical device that relies on a pass/fail outcome against established engineering and biocompatibility standards, not expert interpretation of medical images or biological samples. The "ground truth" is determined by the results of the specified physical and chemical tests.
-
Adjudication method for the test set:
- Not applicable. As this involves objective, quantifiable laboratory tests against defined numerical criteria (e.g., specific tensile strength, elongation percentages, lack of leakage, breakthrough times), there is no need for expert adjudication. The results are directly compared to the acceptance criteria.
-
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 examination glove, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed, and thus no effect size for AI assistance is relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through physical and chemical testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established industry standards and regulatory requirements (e.g., ASTM and ISO standards). For example, for "Freedom from Pinholes," the ground truth is "no leakage" at an AQL 2.5%, determined by empirical testing methods defined in ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time for each specific drug, evaluated against a performance threshold (e.g., >240 minutes for no breakthrough).
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 17, 2024
O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K242558
Trade/Device Name: Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid 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: November 18, 2024 Received: November 18, 2024
Dear Caitlin Senter:
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-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 medical devices and radiation-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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242558
Device Name
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Indications for Use (Describe)
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.
Warning: Not for use with Carmustine, Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
| Fentanyl Citrate Injection (50 mcg/5 ml) |
|---|
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
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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Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through them. To the right of the letters is the company name "Owens & Minor" in a light gray color.
510(k) Summary for K242558
This summary of 510(k) K242558 is being submitted in accordance with 21 CFR 807.92.
| 1. Date Summary was Prepared | December 13, 2024 |
|---|---|
| 2. 510(k) Submitter | O & M Halyard, Inc.9120 Lockwood Blvd.Mechanicsville, Virginia 23116 |
| 3. Primary Contact for this 510(k) Submission | Caitlin Senter, MS, RACTel: 678-221-7330Email: caitlin.senter@owens-minor.com |
| 4. Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| 5. Device Submission Trade name and Description | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
| 6. Device Common Name | Medical Exam Gloves |
| 7. Device Product Code and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty;OPJ Class I, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsQDO Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| 8. Predicate Device | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves (K220373) |
| 9. Reference Devices | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929)Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633) |
| 11. Subject Device Description | The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile,powder-free, textured, ambidextrous, non-sterile patient examination glovethat is packed in a cardboard dispenser box. |
| The devices follow consensus standards: | |
| ASTM D5151-06 Standard Test Method for Detection of Holes in MedicalGloves | |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves forMedical Applications | |
| ASTM D6124-06 Standard Test Method for Residual Powder on MedicalGloves | |
| ASTM D6978-05 Standard Practice for Assessment of Resistance of MedicalGloves to Permeation by Chemotherapy Drugs | |
| ISO 10993-11: 2017 Biological evaluation of medical devices – Tests forsystemic toxicity | |
| ISO 10993-10: 2021 Biological evaluation of medical devices -Part 10: Testsfor skin sensitization | |
| ISO 10993-23: 2021 Biological evaluation of medical devices -Part 23: Testsfor irritation |
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Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray color. The font used for the words is a serif font.
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Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray.
| 12. Indications for Use forHalyard Black Nitrile Powder-Free Exam Gloves with TexturedGrip Technology, Tested for Usewith Chemotherapy Drugs,Fentanyl Citrate, SimulatedGastric Acid and Fentanyl inSimulated Gastric Acid | Halyard Black Nitrile Powder-Free Exam Gloves with Textured GripTechnology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposabledevices intended for medical purposes that is worn on the examiner's hand toprevent contamination between patient and examiner. |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
| Cisplatin | 1 mg/ml |
|---|---|
| Cyclophosphamide | 20 mg/ml |
| Dacarbazine | 10 mg/ml |
| Doxorubicin HCl | 2 mg/ml |
| Etoposide | 20 mg/ml |
| Fluorouracil | 50 mg/ml |
| Ifosfamide | 50 mg/ml |
| Mitoxantrone HCl | 2 mg/ml |
| Paclitaxel | 6 mg/ml |
| Vincristine Sulfate | 1 mg/ml |
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes:
| Carmustine | 3.3 mg/ml: Do not use |
|---|---|
| ------------ | ----------------------- |
CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes:
| Thiotepa | 10 mg/ml: Do not use |
|---|---|
| ---------- | ---------------------- |
Warning: Not for use with Carmustine, Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
| Fentanyl Citrate Injection | (50 mcg/5 ml) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
|---|---|
| ---------------------------- | ------------------------------------------------------------------------------------------ |
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Image /page/8/Picture/0 description: The image is a logo for Owens & Minor. The logo consists of two parts: a maroon-colored symbol on the left and the company name "Owens & Minor" in gray on the right. The symbol on the left appears to be a stylized representation of the letters "OM" with horizontal lines running through it.
| 13. | Subject DeviceHalyard BlackNitrile Powder-FreeExam Gloves withTextured Grip | Predicate DeviceK220373 | Reference DeviceK213929 | Reference DeviceK200633 | Comparison |
|---|---|---|---|---|---|
| FDA ProductCode | LZA, LZC, OPJ, QDO | LZA, OPJ, QDO | LZA, OPJ, QDO | LZA, QDO, LZC | Similar |
| FDAClassification | Class I | Class I | Class I | Class I | Same |
| RegulationNumber | 880.6250 | 880.6250 | 880.6250 | 880.6250 | Same |
| Common Name | Non-PowderedPatient ExaminationGlove | Non-PowderedPatientExamination Glove | Non-PowderedPatientExamination Glove | Non-PowderedPatientExamination Glove | Same |
| Device TradeName | Halyard Black NitrilePowder-Free ExamGloves withTextured GripTechnology, Testedfor Use withChemotherapyDrugs, FentanylCitrate, SimulatedGastric Acid andFentanyl inSimulated GastricAcid | Get-A-Grip/Rescue-Grip,Nitrile Two TonedBlack/Green,Diamond GripTechnology,Powder-Free, Non-sterile,Ambidextrous,Beaded Cuff,Medical GradeExam Gloves | Halyard PurpleNitrile, Powder-Free Exam Gloves | Halyard Black-FirePowder-FreeNitrile Exam Glove | Similar |
| Intended Use | The device is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand topreventcontaminationbetween patientand examiner.These gloves weretested for use withchemotherapydrugs, fentanylcitrate, simulatedgastric acid andfentanyl insimulated gastricacid as listed on thelabel. | A Nitrile powderfree exam glove isa disposabledevice, worn onthe hand or fingerto preventcontaminationbetween examinerand patient orvictim.This specialtyglove has alsobeen tested foruse with theOpioid drugsFentanyl citrate,Heroin, and bothOpioids insimulated GastricAcid as listed onthe label. | The devices aredisposable devicesintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner.These gloves weretested for usewithchemotherapydrugs, fentanylcitrate, simulatedgastric acidfluid/fentanylcitrate injectionmix 50/50Solution as listedon the label. | The devices aredisposable devicesintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner.These gloves weretested for usewith fentanylcitrate as listed onthe label. | Similar |
| TechnologicalCharacteristics | Colored, 9.5 inch,chlorinated, nitrile,powder-free,textured,ambidextrous, non-sterile patientexamination glove | Colored, 9.5 inch,chlorinated, nitrile,powder-free,textured,ambidextrous,non-sterile patientexamination glove | Colored, 9.5 inch,chlorinated,nitrile, powder-free, texturedfingertip,ambidextrous,non-sterile patientexamination glove | Colored, 9.5 inch,chlorinated,nitrile, powder-free, texturedfingertip,ambidextrous,non-sterile patientexamination glove | Similar |
| Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL | Similar |
| Glove Length | 9.5 inch | 9.5 inch | 12 inch | 9.5 inch | Similar |
| Texture | Textured on dorsaland palmar sidesthrough thefingertips | Textured on dorsaland palmar sidesthrough thefingertips | Texturedfingertips | Texturedfingertips | Similar |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized, maroon-colored font, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a gray, sans-serif font. The logo is clean and professional, and the colors are muted and sophisticated.
| 14. Standard | Subject DeviceHalyard BlackNitrile Powder-Free Exam Gloveswith Textured Grip | Predicate Device K220373 | Reference DeviceK213929 | ReferenceDeviceK200633 | Comparison | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6978-05StandardPractice forAssessment ofResistance ofMedical Glovesto PermeationbyChemotherapyDrugs | The followingchemotherapydrugs andconcentration hadNO breakthroughdetected up to 240minutes:Cisplatin, 1 mg/mlCyclophosphamide,20 mg/mlDacarbazine, 10mg/mlDoxorubicin HCl, 2mg/mlEtoposide, 20mg/mlFluorouracil, 50mg/mlIfosfamide, 50mg/mlMitoxantrone HCl,2 mg/mlPaclitaxel, 6 mg/mlVincristine Sulfate,1 mg/mlCAUTION: The | This specialty glove has alsobeen tested for use with theOpioid drugs Fentanyl citrate,Heroin, and both Opioids insimulated Gastric Acid.Test Opioid Drug Concentration MinimumBreakthrough Time Fentanyl citrate (injectable) (100mcg/2ml) >240 minutes Fentanyl citrate (injectable)+ Heroin (100mcg/2ml)+(saturated solution) >240 minutes Fentanyl citrate (injectable)+ Heroin in Simulated GastricAcid Mix 100mcg/2mlSaturated Solution intosimulated Gastric Acid >240 minutes | The followingchemotherapydrugs andconcentration hadNO breakthroughdetected up to240 minutes:Azacitidine (25mg/ml)Bendamustine HCl(5 mg/ml)Bleomycin Sulfate(15 mg/ml)Bortezomib (1mg/ml)Busulfan (6mg/ml)Capecitabine (26mg/ml)Carboplatin (10mg/ml) Carfilzomib(2 mg/ml)Cetuximab (2mg/ml)Chloroquine (50mg/ml)Cisplatin (1 | The followingdrugsshowed notbreakthroughat 240minutes:FentanylCitrate, 100mcg/2ml | Similar |
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Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon font on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a gray, serif font.
| followingchemotherapydrug andconcentrationshowedbreakthroughdetected in lessthan 60 minutes:Carmustine, 3.3mg/ml: Do not use | mg/ml) Cladribine(1 mg/ml)Cyclophosphamide(20 mg/ml)Cyclosporin A (100mg/ml)Cytarabine(Cytosine) (100mg/ml) Cytovene(Ganciclovir) (10mg/ml)Dacarbazine(DTIC) (10 mg/ml)Dactinomycin (0.5mg/ml)Daunorubicin HCl(5 mg/ml)Decitabine (5mg/ml)Docetaxel (10mg/ml)Doxorubicin HCl (2mg/ml)Epirubicin HCl(Ellence) (2mg/ml) Etoposide(Toposar) (20mg/ml)Fludarabine (25mg/ml) 5-Fluorouracil (50mg/ml)Fulvestrant (50mg/ml)Gemcitabine (38mg/ml)Idarubicin (1mg/ml) Ifosfamide(50 mg/ml)Irinotecan HCl (20mg/ml) LeuprolideAcetate Salt (5mg/ml)MechlorethamineHCl (1 mg/ml)Melphalan (5mg/ml)Methotrexate (25mg/ml) MitomycinC (0.5 mg/ml)Mitoxantrone (2mg/ml) Oxaliplatin(5 mg/ml)Paclitaxel (6mg/ml)Pemetrexed (25mg/ml) |
|---|---|
| CAUTION: Thefollowingchemotherapydrug andconcentrationshowedbreakthroughdetected in lessthan 120 minutes:Thiotepa, 10mg/ml: Do not use | |
| Warning: Not foruse withCarmustine,Thiotepa | |
| The followinghazardous drugs(opioids) andconcentration hadNO breakthroughdetected up to 240minutes:Fentanyl CitrateInjection (50 mcg/5ml) SimulatedGastric AcidFluid/FentanylCitrate InjectionMix 50/50 Solution |
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Image /page/11/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the "O". To the right of the letters is the company name "Owens & Minor" in a gray color. The font is sans-serif and the overall design is clean and professional.
| BiocompatibilitySensitizationISO 10993-10 | ||||||
|---|---|---|---|---|---|---|
| Under theconditions of thestudy, not asensitizer. | Under the conditions of thestudy, not a sensitizer. Underthe conditions of the study,not an irritant. | Raltitrexed (0.5 mg/ml) Retrovir(10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Topotecan HCl (1 mg/ml) Triclosan(2 mg/ml)Trisenox (1 mg/ml)Vinblastine Sulfate(1 mg/ml)Vincristine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid(0.8 mg/ml)The followingchemotherapydrugs andconcentrationshowedbreakthroughdetected in lessthan 90 minutes:Carmustine (3.3mg/ml) Nobreakthrough upto 55.3 minutes.Thiotepa (10mg/ml) Nobreakthrough upto 78.8 minutes.Warning- Not foruse withCarmustine andThioTEPANo breakthroughwas detected upto 240 minutes forFentanyl CitrateInjection (100mcg/2 ml) andSimulated GastricAcidFluid/FentanylCitrate InjectionMix 50/50Solution | Under theconditions of thestudy, not asensitizer. Underthe conditions ofthe study | Under theconditions ofthe study,not asensitizer.Under the | Same | |
| irritant. | conditions ofthe study,not anirritant. | |||||
| BiocompatibilityCytotoxicityISO 10993-5 | Not Performed | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells. Cytotoxicityconcern was addressed byacute systematic toxicitytesting. | Not Performed | NotPerformed | DifferentfromK220373Same asK200633andK213929 | |
| BiocompatibilityAcute SystemicToxicityISO 10993-11 | Under theconditions of thestudy, the deviceextract does notinduce acutesystemic toxicityresponse. | Under the conditions of thisstudy, there was no evidenceof acute systemic toxicity. | Under theconditions of thisstudy, there wasno evidence ofacute systemictoxicity. | Under theconditions ofthis study,there was noevidence ofacutesystemictoxicity. | Same | |
| BiocompatibilityIrritationISO 10993-23 | Under theconditions of thestudy, not anirritant. | Not Performed | Not Performed | NotPerformed | Different |
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15. SUMMARY OF NON-CLINICAL TESTING
Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface Device and duration of contact is A-Limited (≤24h). The following tests for the proposed device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff-Medical Guidance Manual issued on January 22, 2008.
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Systemic Toxicity
Performance Testing
Physical Performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application testing was conducted to support the addition of the labeling claim. Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (2023) 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 and fentanyl citrate.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance to the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- • ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 Standard Practice for Assessment of resistance of Medical Gloves to Permeation by . Chemotherapy Drugs
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For the test result, we can find the product can meet the requirements as its intended use indicated.
| Test Method | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions(Length) (Width)(Thickness) | ASTM D6319 | PASS | |
| Length | ≥230 mm | ||
| Palm Width Size | X-Small: 60 – 80 mmSmall: 70 - 90 mmMed: 85–105 mmLarge: 100 - 120 mmX-Large: 110-130 mmXX-Large: 120-140 mm | ||
| Finger thickness | ≥0.05 mm | ||
| Palm thickness | ≥0.05 mm | ||
| Cuff thickness | ≥0.05 mm | ||
| Physical Properties | ASTM D 6319 | AQL 4.0Before AgingTensile Strength: ≥14 MPaUltimate elongation: ≥500%After AgingTensile Strength: ≥14 MPaUltimate elongation: ≥400% | PASS |
| Freedom fromPinholes | ASTM D 6319ASTM D 5151 | AQL 2.5%No leakage | PASS |
| Residual Powder | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | PASS |
| Permeation byChemotherapy Drugs | ASTM D6978 | Refer to the abovetable | PASS |
| Test for irritation | ISO 10993, Part 23 | No dermalirritationreactions | PASS |
| Test for acutesystemic toxicity | ISO 10993, Part 11 | Under the conditionsof the study, thedevice extract doesnot induce acutesystemic toxicityresponse. | PASS |
| Test for skinsensitization | ISO 10993, Part 10 | No dermal reactionsindicative of delayedcontacthypersensitivity. | PASS |
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- CLINICAL TEST CONCLUSION No clinical study is included in this submission.
17. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in K242558, Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220373.
§ 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.