Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs

K200843 · O&M Halyard, Inc. · LZA · Sep 22, 2020 · General Hospital

Device Facts

• Record ID: K200843
• Device Name: Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
• Applicant: O&M Halyard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Sep 22, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM-D6978-05: Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Bortezomib (6 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Capecitabine (26 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Chloroquine (50 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 Cyclosporine A (100 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 Dactinomycin (0.5 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 5-Fluorouracil (50 mg/ml) Nobreakthrough 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 Leuprolide acetate salt (5mg/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 Pemetrexed (25 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 mimutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (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 Fentany I Citrate Injection, (100mcg /2mL). No breakthrough up to 240 minutes

Device Story

Disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Provides barrier protection against specific chemotherapy drugs and Fentanyl Citrate. Performance verified via ASTM D6978-05 permeation testing; most tested agents show no breakthrough up to 240 minutes, with the exception of Carmustine (59 minutes).

Clinical Evidence

Bench testing only. No clinical data. Testing included ASTM D6978-05 (chemotherapy drug permeation), ASTM D5151-06 (leakage/holes), ASTM D6124-06 (residual powder), ASTM D6319-10 (physical dimensions/properties), and ISO 10993 (biocompatibility: systemic toxicity, irritation, sensitization).

Technological Characteristics

Material: Nitrile. Form: Powder-free, chlorinated, textured fingertip, ambidextrous, sterile. Standards: ASTM D5151-06, ASTM D6319-10, ASTM D6124-06, ASTM D6978-05, ISO 10993-10/11.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05.

Regulatory Classification

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.

Predicate Devices

• Halyard Pink Underguard Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K183132)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 22, 2020

೦&M Halyard, Inc. Steven Dowdley Associate Director of Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K200843

Trade/Device Name: Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Glove Tested with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: August 17, 2020 Received: August 21, 2020

Dear Steven Dowdley:

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 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 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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For: CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K200843

#### Device Name

Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drues

#### Indications for Use (Describe)

Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM-D6978-05: Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Bortezomib (6 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Capecitabine (26 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Chloroquine (50 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 Cyclosporine A (100 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 Dactinomycin (0.5 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 5-Fluorouracil (50 mg/ml) Nobreakthrough 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 Leuprolide acetate salt (5mg/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

List of chemotherapy drugs continues on next page

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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K200843: Continuation of the list of chemotherapy drugs from previous page. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05:

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 Pemetrexed (25 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 mimutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (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

Fentany I Citrate Injection, (100mcg /2mL). No breakthrough up to 240 minutes

CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes. Carmustine (BCNU): 59 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

| Date Summary<br>was Prepared | September 19, 2020 |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc.<br>5405 Windward Parkway<br>Alpharetta, GA 30004 |
| Primary Contact for<br>this 510(k) Submission | Steven Dowdley, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Device Trade Name | Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with<br>Chemotherapy Drugs |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZC<br>Class I, 21 CFR §880.6250 Patient Examination Glove<br>LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty<br>OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| Predicate Device | Halyard Pink Underguard Zero Nitrile Powder-Free Exam Glove Tested for<br>Use with Chemotherapy Drugs cleared under K183132 |
| Subject Device Description | The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam<br>Gloves Tested with Chemotherapy Drugs are disposable, pink-colored,<br>chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile<br>patient examination gloves.<br>The device follows consensus standards:<br>• ASTM D5151-06 Standard Test Method for Detection of Holes in Medical<br>Gloves<br>• ASTM D6319-10 Standard Specification for Nitrile Examination Gloves<br>for Medical Applications<br>• ASTM D6124-06 Standard Test Method for Residual Powder on Medical<br>Gloves<br>• ASTM D6978-05 Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy Drugs |
| | • ISO 10993-11:2017, Biological evaluation of medical devices - Part11:<br>Tests for Systemic Toxicity<br>• ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10:<br>Tests for Irritation and Skin Sensitization |
| Indications for Use for the<br>Halyard Pink Underguard Zero,<br>Sterile Powder-Free Exam Glove<br>Tested with Chemotherapy | The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves<br>Tested with Chemotherapy Drugs are disposable devices intended for medical<br>purposes that is worn on the examiner's hand to prevent contamination between<br>patient and examiner. These gloves were tested for use with the following |
| Drugs | chemotherapy drugs and Fentanyl Citrate as per ASTM -D6978-05.: |
| | Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes |
| | Bendamustine (5 mg/ml) No breakthrough up to 240 minutes |
| | Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes |
| | Bortezomib (6 mg/ml) No breakthrough up to 240 minutes |
| | Busulfan (6 mg/ml) No breakthrough up to 240 minutes |
| | Capecitabine (26 mg/ml) No breakthrough up to 240 minutes |
| | Carboplatin (10 mg/ml) No breakthrough up to 240 minutes |
| | Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes |
| | Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes |
| | Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes |
| | Chloroquine (50 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 |
| | Cyclosporine A (100 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 |
| | Dactinomycin (0.5 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 |
| | 5-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 |
| | Leuprolide acetate salt (5mg/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 |
| | Pemetrexed (25 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 |
| | ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes |
| | Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes |
| | Triclosan (1 mg/ml) No breakthrough up to 240 minutes |
| | Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes |
| | Vinblastine (1 mg/ml) No breakthrough up to 240 minutes |
| | Vincrinstine Sulfate (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 |
| | Fentanyl Citrate (100mcg/2ml) No breakthrough up to 240 minutes. |
| | CAUTION: The following chemotherapy drugs and concentration showed<br>breakthrough detected in less than 60 minutes: Carmustine (BCNU): 59<br>minutes. |

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| Summary of comparison of technological characteristics | The subject device and the predicate device are both sterile, powder-free nitrile exam gloves tested for resistance to permeation by chemotherapy drugs. |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|

| Technological Characteristics Comparison Table | | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Subject Device | Predicate Device K183132 | Comparison |
| FDA Product Code | LZA, LZC, QDO | LZA, LZC | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | Halyard Pink Underguard Zero<br>Nitrile Sterile Powder-Free<br>Exam Gloves Tested with<br>Chemotherapy Drugs | Halyard Pink Underguard Nitrile<br>Powder-Free Exam Glove Tested for<br>Use with Chemotherapy Drugs | Similar |
| Intended Use | Halyard Pink Underguard Nitrile<br>Sterile Powder-Free Exam Gloves<br>Tested with Chemotherapy Drugs<br>are disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. These gloves were<br>tested for use with chemotherapy<br>drugs listed on the label. | The Halyard Pink Underguard<br>Nitrile Powder-Free Exam Glove<br>Tested for Use with Chemotherapy<br>Drugs is a disposable device<br>intended for medical purposes that<br>is worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner.<br>These gloves were tested for use<br>with chemotherapy drugs listed on<br>the label. | Same |
| Technological<br>Characteristics | The glove is a colored, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, patient examination<br>glove. | The glove is a colored, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, patient examination<br>glove. | Same |
| Sizes of gloves | XS, S, M, L, XL(Sterile) | XS, S, M, L, XL | Different |
| Texture | Textured fingertips (Sterile) | Textured fingertips | Different |

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| Sterility | Sterile. | Non Sterile | Different |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Biocompatibility | Based ISO 10993 Biological<br>evaluation of Medical devices -<br>Test for Systemic Injection, the<br>test article was considered non-<br>toxic. Meets the acceptance<br>criteria. | Based ISO 10993 Biological<br>evaluation of Medical devices -<br>Test for Systemic Injection, the test<br>article was considered non-toxic.<br>Meets the acceptance criteria. | Similar |
| | Based on ISO 10993- Biological<br>evaluation of Medical Devices -<br>Test for Skin Irritation, the device<br>extracts were not found to cause a<br>systemic response in the animal<br>model. Meets the acceptance<br>criteria. | Based on ISO 10993- Biological<br>evaluation of Medical Devices -<br>Test for Skin Irritation, the device<br>extracts were not found to cause a<br>systemic response in the animal<br>model. Meets the acceptance<br>criteria. | |
| | Based on ISO 10993- Biological<br>evaluation of Medical Device<br>Dermal Sensitization-<br>ISO Kligman Maximization Test -<br>NaCl and CSO extracts. The test<br>article were classified as a non-<br>sensitizer. Based on the criteria of<br>the protocol, the test article meets<br>the requirements of the ISO<br>10993-10 guidelines. | Based on ISO 10993- Biological<br>evaluation of Medical Device<br>Dermal Sensitization-<br>ISO Kligman Maximization Test -<br>NaCl and CSO extracts. The test<br>article were classified as a non-<br>sensitizer. Based on the criteria of<br>the protocol, the test article meets<br>the requirements of the ISO 10993-<br>10 guidelines. | |

| Performance Data for Chemotherapy Drugs | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…