(84 days)
The Halyard Pink Underguard Nittile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
- · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- · Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- · Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
- · Rituximab (10 mg/ml) No breakthrough up to 240 minutes
- · Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
- Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
- · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
- · Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
- Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
- · Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
- · Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
- · ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes
Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non- sterile patient examination gloves that are packed in a cardboard dispenser box.
The device described is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
| Characteristic / Test Method | Acceptance Criteria (from standard) | Reported Device Performance |
|---|---|---|
| ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | No signs of breakthrough after 4 hours for 50 drugs, except for Carmustine and ThioTEPA. | Meets Acceptance Criteria: - No breakthrough up to 240 minutes for 50 chemotherapy drugs: Arsenic Trioxide (1 mg/ml), Azacitidine (Vidaza) (25 mg/ml), Bendamustine (5 mg/ml), Bortezomib (Velcade) (1 mg/ml), Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Carfilzomib (2 mg/ml), Cetuximab (Erbitux) (2 mg/ml), Cisplatin (1 mg/ml), Cladribine (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCL (100 mg/ml), Cytovene (10 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCL (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCL (2 mg/ml), Ellence (2 mg/ml), Etoposide (20 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan (20 mg/ml), Mechlorethamine HCL (1 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin (0.5 mg/ml), Mitoxantrone (2 mg/ml), Oxaliplatin (2 mg/ml), Paclitaxel (6 mg/ml), Paraplatin (10 mg/ml), Pemetrexed (25 mg/ml), Pertuzumab (30 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Trastuzumab (21 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1.0 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml). - Limited breakthrough times for specific drugs: Carmustine (3.3 mg/ml): No breakthrough up to 54.7 minutes ThioTEPA (10 mg/ml): No breakthrough up to 128.5 minutes |
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves | 2.5% AQL (Acceptable Quality Limit) for leakage. | Meets the 2.5% AQL requirement for leakage. |
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications | Within limits for physical dimensions; meet requirements for tensile strength and elongation. (Specific numerical criteria for tensile strength and elongation are implied by the standard but not fully detailed in the provided text for acceptance, only for performance. For the predicate, 38 MPa tensile strength after aging and 550% elongation after aging are mentioned as targets). | Physical dimensions are within the limits of the standard. Physical Properties: - Tensile Strength: Average 37.89 MPa before aging, 39.32 MPa after aging. - Elongation: 602% before aging, 558% after aging. |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Powder-free limit of < 2 mg maximum powder per glove. | Average of 0.4 mg/glove, meeting the powder-free limit. |
| ISO 10993-11: 2017 Tests for Systemic Toxicity (Systemic Injection Test in Mice) | No mortality or evidence of systemic toxicity. | No mortality or evidence of systemic toxicity from the extracts (NaCl and Cottonseed Oil). |
| ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization (Dermal Irritation Test in Rabbits) | Extracts considered non-irritating. | Test article extracts were considered non-irritating. |
| ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization (Dermal Sensitization Test) | No evidence of causing delayed dermal contact sensitization. | Test article extracts showed no evidence of causing delayed dermal contact sensitization. |
Detailed Study Information:
The provided document is a 510(k) Premarket Notification summary from the FDA, evaluating the subject device against a predicate device. The "studies" are in fact non-clinical performance tests conducted against recognized international standards and ASTM methods.
2. Sample size used for the test set and the data provenance
- ASTM D6978-05 (Chemotherapy Drug Permeation): The document does not specify the exact sample size (number of gloves or replicates for each drug) used for the permeation testing for the subject device. The predicate device tested 12 drugs, while the subject device tested 52 drugs. The data provenance is not explicitly stated as country of origin, but it is implied to be laboratory testing for regulatory submission in the US (FDA). The nature of these tests is prospective for the purpose of the submission.
- ASTM D5151-06 (Holes in Medical Gloves): The document does not specify the exact sample size. It states that testing "meets the 2.5% AQL requirement," which implies a sampling plan was used according to the standard, but the specific number of gloves tested is not provided. Data provenance is implied as laboratory testing.
- ASTM D6319-10 (Physical Properties): The document mentions average tensile strength and elongation values before and after aging. The sample size for these measurements (number of gloves or test specimens) is not specified. Data provenance is implied as laboratory testing.
- ASTM D6124-06 (Residual Powder): The document notes an "average of 0.4 mg/glove." The sample size for this average is not provided. Data provenance is implied as laboratory testing.
- ISO 10993-11 (Systemic Toxicity): The test specifies "ISO Systemic Injection Test in Mice." The number of mice used is not provided. Data provenance is implied as laboratory testing.
- ISO 10993-10 (Dermal Irritation): The test specifies "ISO Indirect Primary Skin Irritation Test in Rabbits." The number of rabbits used is not provided. Data provenance is implied as laboratory testing.
- ISO 10993-10 (Dermal Sensitization): The test specifies "ISO Kligman Maximization Test." The number of animals used is not provided. Data provenance is implied as laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of submission (510(k) for a medical glove) does not involve human expert interpretation of data in the way a diagnostic AI would. The "ground truth" for these tests are the objective measurements from laboratory instruments and observations by trained technicians following standardized protocols (e.g., timing of breakthrough, physical property measurements, biological responses in animal models). Therefore, there were no "experts" establishing ground truth in the context of radiologists or similar clinical experts.
4. Adjudication method for the test set
Not applicable. As described in point 3, these are objective laboratory tests against established standards. There is no subjective interpretation or adjudication process required between multiple human readers or experts for the test results.
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 is a submission for a non-diagnostic physical medical device (exam glove) and does not involve AI, human readers, or medical imaging, so an MRMC study is irrelevant here.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component to this medical device.
7. The type of ground truth used
The "ground truth" in this context refers to the directly measured and objectively determined results from standardized laboratory tests. These include:
- Direct measurement of permeation time: For chemotherapy drugs (ASTM D6978-05).
- Observed absence/presence of leakage: For holes (ASTM D5151-06).
- Direct physical measurements: Tensile strength, elongation, glove dimensions (ASTM D6319-10).
- Direct chemical measurement: Residual powder weight (ASTM D6124-06).
- In-vivo biological observations: Mortality, signs of systemic toxicity, irritation, dermal sensitization in animal models (ISO 10993-11, ISO 10993-10).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set." The product undergoes manufacturing processes, and quality control tests (which might involve some internal data collection over time) ensure consistency, but this is distinct from training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 5, 2019
0 & M Halyard, Inc. Angela Bunn Director of Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K183132
Trade/Device Name: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 8, 2018 Received: November 13, 2018
Dear Angela Bunn:
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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183132
Device Name
Halyard Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Halyard Pink Underguard Nittile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
- · Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
- · Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
- · Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
- · Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
- · Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
- · Busulfan (6 mg/ml) No breakthrough up to 240 minutes
- Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
- Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
- Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
- · Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
- · Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
- · Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
- · Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
- Cytovene (10 mg/ml) No breakthrough up to 240 minutes
- · Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
- · Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
- Decitabine (5 mg/ml) No breakthrough up to 240 minutes
- Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
- · Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
- · Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
- Etoposide (20 mg/ml) No breakthrough up to 240 minutes
- Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
- · Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
- Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
- · Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
- Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
- · Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
- Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
- · Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
- Melphalan (5 mg/ml) No breakthrough up to 240 minutes
- · Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
- · Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
- · Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
- Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
- Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
- Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
- Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
- Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
- Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
- · Retrovir (10 mg/ml) No breakthrough up to 240 minutes
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- · Rituximab (10 mg/ml) No breakthrough up to 240 minutes
- · Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
- Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
- · Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
- · Triclosan (2 mg/ml) No breakthrough up to 240 minutes
- Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
- · Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
- Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
- · Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
- · Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:
- Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
- · ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K183132)
| Date Summary wasPrepared | January 31,2019 |
|---|---|
| 510(k) Submitter | Angela L. Bunn, RACDirector Regulatory AffairsTel: 470-448-5856Email: angela.bunn@hyh.com |
| Primary Contact for this510(k) Submission | Same as above |
| Device Trade Name | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs |
| Device Common Name | Non-Powdered Patient Examination Glove |
| Device Product Code andClassification Name | LZA, LZCClass I, 21 CFR §880.6250Patient Examination Glove |
| Predicate Device | K081089Halyard Sterling Nitrile-Xtra Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs |
| Subject Device Description | Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile,powder-free, textured fingertip, ambidextrous, non- sterile patient examinationgloves that are packed in a cardboard dispenser box. |
| Indications for Use | The Halyard® Pink Underguard Nitrile Powder-Free Exam Glove Tested for Usewith Chemotherapy Drugs is a disposable device intended for medical purposesthat is worn on the examiner's hand to prevent contamination between patient andexaminer. These gloves were tested for use with the following chemotherapydrugs:● Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes● Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes● Bendamustine (5 mg/ml) No breakthrough up to 240 minutes● Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes● Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes● Busulfan (6 mg/ml) No breakthrough up to 240 minutes● Carboplatin (10 mg/ml) No breakthrough up to 240 minutes |
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| Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes●Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes●Cisplatin (1 mg/ml) No breakthrough up to 240 minutesCladribine (1.0 mg/ml) No breakthrough up to 240 minutes●Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutesCytarabine HCL (100 mg/ml) No breakthrough up to 240 minutesCytovene (10 mg/ml) No breakthrough up to 240 minutes●Dacarbazine (10 mg/ml) No breakthrough up to 240 minutesDaunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutesDecitabine (5 mg/ml) No breakthrough up to 240 minutesDocetaxel (10 mg/ml) No breakthrough up to 240 minutesDoxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes●Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutesEtoposide (20 mg/ml) No breakthrough up to 240 minutes●Fludarabine (25 mg/ml) No breakthrough up to 240 minutes●Fluorouracil (50 mq/ml) No breakthrough up to 240 minutesFulvestrant (50 mg/ml) No breakthrough up to 240 minutes●Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes●ldarubicin (1 mq/ml) No breakthrough up to 240 minuteslfosfamide (50 mq/ml) No breakthrough up to 240 minutesIrinotecan (20 mg/ml) No breakthrough up to 240 minutesMechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutesMelphalan (5 mg/ml) No breakthrough up to 240 minutesMethotrexate (25 mg/ml) No breakthrough up to 240 minutesMitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutesMitoxantrone (2 mg/ml) No breakthrough up to 240 minutesOxaliplatin (2 mg/ml) No breakthrough up to 240 minutesPaclitaxel (6 mg/ml) No breakthrough up to 240 minutesParaplatin (10 mg/ml) No breakthrough up to 240 minutesPemetrexed (25 mq/ml) No breakthrough up to 240 minutes●Pertuzumab (30 mg/ml) No breakthrough up to 240 minutesRaltitrexed (0.5 mg/ml) No breakthrough up to 240 minutesRetrovir (10 mg/ml) No breakthrough up to 240 minutesRituximab (10 mg/ml) No breakthrough up to 240 minutesTemsirolimus (25 mg/ml) No breakthrough up to 240 minutesTrastuzumab (21 mg/ml) No breakthrough up to 240 minutesTopotecan HCL (1 mg/ml) No breakthrough up to 240 minutes●Triclosan (2 mg/ml) No breakthrough up to 240 minutesTrisonex (1.0 mg/ml) No breakthrough up to 240 minutes●Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes● |
|---|
| Vinblastine (1 mg/ml) No breakthrough up to 240 minutes●Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes●Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes●Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutesThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes |
| Technological Characteristic Comparison Table | |||
|---|---|---|---|
| Subject Device:K183132 | Predicate Device:K081089 | Comparison | |
| FDA ProductCode | LZA, LZC | LZC | Same |
| FDAClassification | Class I | Class I | Same |
| Common Name | Non-PowderedPatient Examination Glove | Non-PowderedPatient Examination Glove | Same |
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| Device TradeName | Halyard Pink Underguard NitrilePowder-Free Exam GlovesTested for Use withChemotherapy Drugs | Halyard Sterling Nitrile XtraPowder-Free Exam GlovesTested for Use withChemotherapy Drugs | Similar |
|---|---|---|---|
| Indications forUse | The Halyard Pink UnderguardNitrile Powder-Free NitrileExam Glove is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner. These gloveswere tested for use withchemotherapy drugs listed onthe label. | The Halyard Sterling Nitrile-XtraPowder-Free Exam Glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves weretested for use with chemotherapydrugs listed on the label. | Same |
| TechnologicalCharacteristics | Pink-colored, 12-inch, 0.09mm thick at palm, nitrile,powder-free, texturedfingertip, ambidextrous, non-sterile patient examinationglove. | Gray-colored, 12-inch, 0.90 mmthick at palm, nitrile, powder-free,textured fingertip, ambidextrous,non- sterile patient examinationglove. | Similar |
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| Technological Charateristic Comparison Table | |||
|---|---|---|---|
| Standard | Subject Device:K183132 | Predicate Device:K081089 | Comparison |
| TM D6978-05Standard Practice forAssessment ofResistance ofMedical Gloves toPermeation byChemotherapy Drugs | No signs of breakthrough after 4 hours for 50drugs.Result: Meets acceptance criteria.No breakthrough up to 240 minutes:Arsenic Trioxide (1 mg/ml)Azacitidine (Vidaza) (25 mg/ml)Bendamustine (5 mg/ml)Bortezomib (Velcade) (1 mg/ml)Bleomycin sulfate (15 mg/ml)Busulfan (6 mg/ml)Carboplatin (10 mg/ml)Carfilzomib (2 mg/ml)Cetuximab (Erbitux) (2 mg/ml)Cisplatin (1 mg/ml)Cladribine (1 mg/ml)Cyclophosphamide (20 mg/ml)Cytarabine HCL (100 mg/ml)Cytovene (10 mg/ml)Dacarbazine (10 mg/ml)Daunorubicin HCL (5 mg/ml)Decitabine (5 mg/ml)Docetaxel (10 mg/ml)Doxorubicin HCL (2 mg/ml)Ellence (2 mg/ml)Etoposide (20 mg/ml)Fludarabine (25 mg/ml)Fluorouracil (50 mg/ml)Fulvestrant (50 mg/ml)Gemcitabine (38 mg/ml)Idarubicin (1 mg/ml)Ifosfamide (50 mg/ml)Irinotecan (20 mg/ml)Mechlorethamine HCL (1 mg/ml)Melphalan (5 mg/ml)Methotrexate (25 mg/ml)Mitomycin (0.5 mg/ml)Mitoxantrone (2 mg/ml)Oxaliplatin (2 mg/ml)Paclitaxel (6 mg/ml)Paraplatin (10 mg/ml)Pemetrexed (25 mg/ml)Pertuzumab (30 mg/ml)Raltitrexed (0.5 mg/ml)Retrovir (10 mg/ml)Rituximab (10 mg/ml)Temsirolimus (25 mg/ml)Trastuzumab (21 mg/ml)Topotecan HCL (1 mg/ml)Triclosan (2 mg/ml)Trisonex (1.0 mg/ml)Vincrinstine Sulfate (1 mg/ml)Vinblastine (1 mg/ml)Vinorelbine (10 mg/ml)Zoledronic Acid (0.8 mg/ml)Carmustine (3.3 mg/ml) No breakthrough up to54.7 minutesThioTEPA (10 mg/ml) No breakthrough up to128.5 minutes | No signs of breakthrough after 4hours for 10 drugs.Result: Meets acceptance criteria.No breakthrough up to 240minutes: 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 (2 mg/ml)Paclitaxel (6 mg/ml)Vincrinstine Sulfate (1mg/ml)Carmustine (3.3 mg/ml)Not for Use with Carmustine ThioTEPA(10.0 mg/ml)Not for Use with ThioTEPA | Similar with differentbreakthrough times forCarmustine and ThioTEPA. |
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| Summary ofTechnologicalCharacteristicComparison | There are no different technological characteristics of the subject device compared to the predicatedevice. They are powder-free non-sterile nitrile exam gloves tested for resistance to permeation bychemotherapy drugs. The subject device was tested for use with 52 drugs and the predicate device wastested for use with 12 drugs. The color is different between the subject device and the predicate. |
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| ------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Summary of Non-Clinical Performance Data | ||||||
|---|---|---|---|---|---|---|
| Test Method | Subject Device:K183132 | Test Method | Predicate Device:K081089 | Comparison | ||
| ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves | Testing of the subject deviceshows it meets the 2.5% AQLrequirement in the standardsfor leakage. The device meetsthe acceptance criteria of thestandard. | ASTM D5151-06Standard Test Methodfor Detection of Holes inMedical Gloves | Testing of the predicatedevice shows it meets the2.5% AQL requirement inthe standards for leakage.The device meets theacceptance criteria of thestandard. | Same | ||
| ASTM D6319-10StandardSpecification forNitrileExaminationGloves forMedicalApplications | The physical dimensions of thesubject device are within thelimits of the standard and thephysical properties of thesubject device meet therequirements for tensilestrength with an average beforeaging of 37.89 MPa and afteraging of 39.32 MPa andelongation of 602% beforeaging and 558% after aging. | ASTM D6319-10Standard Specificationfor Nitrile ExaminationGloves for MedicalApplications | The physical dimensionsof the predicate deviceare within the limits of thestandard and thephysical properties of thesubject device meet therequirements for tensilestrength with a targetafter aging of 38 MPaand elongation of 550%after aging. | Similar | ||
| ASTM D6124-06Standard TestMethod forResidualPowder onMedical Gloves | Residual powder on thesubject device is an averageof 0.4 mg/glove within thepowder-free limit of < 2 mgmaximum powder per gloveand meets the acceptancecriteria for powder- free. | ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder on thepredicate device is anaverage of 0.4 mg/glovewithin the powder-freelimit of < 2 mg maximumpowder per glove andmeets the acceptancecriteria for powder- free. | Same | ||
| 10993-11: 2017 Biological evaluation of medical devices - Tests for systemic toxicity. | ||||||
| Systemic Toxicity -ISO SystemicInjection Test inMice – SodiumChloride (NaCI)and Cottonseed Oil(CSO) extracts | No mortality or evidence ofsystemic toxicity from theextracts. | Systemic Toxicity -ISO Systemic InjectionTest in Mice - SodiumChloride (SC) andSesame Oil (SO) extracts | No mortality or evidence ofsystemictoxicityfromthe extracts. | The deviceextracts did notelicit systemicresponses | ||
| 10993-10: 2010 Biological evaluation of medical devices – Tests for irritation and skin sensitization. |
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| Dermal Irritation -ISO IndirectPrimary SkinIrritation Test inRabbits - 0.9%Sodium Chloride(NaCl) for Injectionand Cottonseed Oil(CSO) extracts | Based on the criteria/conditions ofthe study, the test articleextracts wereconsiderednon-irritating. | Dermal Irritation- ISOSkin Irritation Study-Topical article application | Based on the criteria/conditions of the study, thetest article extracts wereconsidered non-irritating. | The deviceextracts are notirritants. |
|---|---|---|---|---|
| DermalSensitization-ISO KligmanMaximization Test- NaCl and CSOextracts | The test article extractsshowed no evidence ofcausing delayed dermalcontactsensitization. | ISO Local Lymph NodeAssay (LLNA) (NaCl andDMSO extracts) | The test article extractsshowed no evidenceof causing delayeddermal contactsensitization. | The deviceextracts are notsensitizers |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs aswell as or better than the legally marketed device, K081089 |
§ 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.