(243 days)
Not Found
No
The device is a disposable medical glove and the description focuses on its physical properties and resistance to chemicals, with no mention of software, algorithms, or data processing.
No.
The device is described as an exam glove for preventing contamination between patient and examiner, not for treating a condition.
No
The device is a medical glove intended for preventing contamination between patient and examiner and protecting the wearer from certain hazardous substances, not for diagnosing medical conditions.
No
The device is described as physical gloves, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The device description confirms it is a glove, a physical barrier.
- Performance Studies: The performance studies focus on the physical properties of the glove, its resistance to certain chemicals (chemotherapy drugs, fentanyl), and its potential for causing skin irritation or sensitization. These are relevant to the glove's function as a protective barrier, not to diagnostic testing of patient samples.
The testing for use with chemotherapy drugs and fentanyl is related to the glove's ability to protect the user from these substances, which is a safety feature of the barrier device, not a diagnostic function.
N/A
Intended Use / Indications for Use
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable devices 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 :
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) 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 following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Warning: Not for Use With: Carmustine, ThioTEPA
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO
Device Description
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves. These gloves will be available in sizes Extra Small, Small, Medium, Large and Extra Large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Dimensions (ASTM D 6319): Meets requirements for length, palm width, finger, palm, and cuff thickness.
- Physical Properties (ASTM D 6319): Meets requirements for tensile strength and ultimate elongation before and after aging.
- Freedom from Pinholes (ASTM D 6319, ASTM D 5151): Meets AQL 2.5% and no leakage.
- Powder Free (ASTM D 6124, ASTM D 6319): Residual powder on the subject device is an average of 0.4 mg/glove, meeting the powder-free limit of
§ 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.
0
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 text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
August 16, 2022
O & M Halyard, Inc. Angela Bunn Director of Global Regulatory Affairs 1 Edison Drive Alpharetta, GA 30005
Re: K213937
Trade/Device Name: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: July 5, 2022 Received: July 11, 2022
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 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.
1
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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. 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
2
Indications for Use
510(k) Number (if known) K213937
Device Name
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Indications for Use (Describe)
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable devices 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml)
3
Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) 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 following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Warning: Not for Use With: Carmustine, ThioTEPA
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image contains a logo for Owens & Minor, a healthcare logistics company. The logo consists of a stylized "OM" in maroon, with horizontal lines within the letters. To the right of the "OM" is the company name "Owens & Minor" in gray. Below the logo is the text "510(k) Summary for K213937".
This summary of 510(k) K213937 is being submitted in accordance with 21 CFR 807.92.
| Date Summary was Prepared | August 16, 2022 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| Primary Contact for | |
| this 510(k) Submission | Angela L. Bunn, RAC |
| Tel: 470-364-7147 | |
| Email: angela.bunn@owens-minor.com | |
| Marketed Device Trade Name | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves |
| Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated | |
| Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| Device Submission Trade name | |
| and Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves |
| Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated | |
| Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove |
| LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty | |
| OQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove | |
| Predicate Device | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested |
| for Use with Chemotherapy Drugs (K202622) | |
| Subject Device Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves |
| Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated | |
| Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are | |
| disposable, lavender colored, chlorinated, nitrile, powder-free, textured | |
| fingertip, ambidextrous, non-sterile patient examination gloves. These | |
| gloves will be available in sizes Extra Small, Small, Medium, Large and Extra | |
| Large. | |
| Indications for Use | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves |
| Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated | |
| Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable | |
| devices 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, Fentanyl Citrate and | |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as | |
| per ASTM -D6978-05 : | |
| The following chemotherapy drugs and concentration had NO breakthrough | |
| detected up to 240 minutes: | |
| Azacitidine (25 mg/ml) | |
| Bendamustine HCl (5 mg/ml) | |
| Bleomycin Sulfate (15 mg/ml) | |
| Bortezomib (1 mg/ml) | |
| Busulfan (6 mg/ml) | |
| Capecitabine (26 mg/ml) | |
| Carboplatin (10 mg/ml) | |
| Carlzomib (2 mg/ml) | |
| Cetuximab (2 mg/ml) | |
| Chloroquine (50 mg/ml) | |
| Cisplatin (1 mg/ml) | |
| Cladribine (1 mg/ml) | |
| Cyclophosphamide (20 mg/ml) | |
| Cyclosporin A (100 mg/ml) | |
| Cytarabine (Cytosine) (100 mg/ml) | |
| Cytovene (Ganciclovir) (10 mg/ml) | |
| Dacarbazine (DTIC) (10 mg/ml) | |
| Dactinomycin (0.5 mg/ml) | |
| Daunorubicin HCl (5 mg/ml) | |
| Decitabine (5 mg/ml) | |
| Docetaxel (10 mg/ml) | |
| Doxorubicin HCl (2 mg/ml) | |
| Epirubicin HCI (Ellence) (2 mg/ml) | |
| Etoposide (Toposar) (20 mg/ml) | |
| Fludarabine (25 mg/ml) | |
| 5-Fluorouracil (50 mg/ml) | |
| Fulvestrant (50 mg/ml) | |
| Gemcitabine (38 mg/ml) | |
| Idarubicin (1 mg/ml) | |
| Ifosfamide (50 mg/ml) | |
| Irinotecan HCl (20 mg/ml) | |
| Leuprolide Acetate Salt (5 mg/ml) | |
| Mechlorethamine HCl (1 mg/ml) | |
| Melphalan (5 mg/ml) | |
| Methotrexate (25 mg/ml) | |
| Mitomycin C (0.5 mg/ml) | |
| Mitoxantrone (2 mg/ml) | |
| Oxaliptin (5 mg/ml) | |
| Paclitaxel (6 mg/ml) | |
| Pemetrexed (25 mg/ml) | |
| 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 following chemotherapy drugs and concentration showed breakthrough | |
| detected in less than 60 minutes: | |
| Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. | |
| Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. | |
| The following hazardous drugs (opioids) and concentration had NO | |
| breakthrough detected up to 240 minutes: | |
| Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid | |
| Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| Warning: Not for Use With: Carmustine, Thiotepa | |
| Intended for Over-the-Counter use | |
5
Image /page/5/Picture/0 description: The image is a 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 a light gray color.
6
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 is the company name "Owens & Minor" in a gray color. The font used for the company name is a serif font.
| Subject Device (K213937) | Predicate Device (K202622) | Comparison | |
|---|---|---|---|
| FDA Product Code | LZC, LZA, OQD | LZC, LZA, OQD | 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 Lavender Nitrile, Low | ||
| Dermatitis Potential, Powder-Free | |||
| Exam Gloves Tested for Use with | |||
| Chemotherapy Drugs and | |||
| Fentanyl Citrate and Simulated | |||
| Gastric Acid Fluid/Fentanyl Citrate | |||
| Injection Mix 50/50 Solution | Halyard Lavender, Nitrile, Powder- | ||
| Free Exam Gloves Tested for Use | |||
| with Chemotherapy Drugs and | |||
| Fentanyl Citrate | Similar | ||
| Intended | |||
| Use/Indications for | |||
| Use | Halyard Lavender Nitrile, Low | ||
| Dermatitis Potential, Powder-Free | |||
| Exam Gloves Tested for Use with | |||
| Chemotherapy Drugs, Fentanyl | |||
| Citrate and Simulated Gastric Acid | |||
| Fluid/Fentanyl Citrate Injection Mix | |||
| 50/50 Solution are disposable devices | |||
| 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, | |||
| Fentanyl Citrate and Simulated | |||
| Gastric Acid Fluid/Fentanyl Citrate | |||
| Injection Mix 50/50 Solution as per | |||
| ASTM -D6978-05 : | |||
| The following chemotherapy drugs | |||
| and concentration had NO | |||
| breakthrough detected up to 240 | |||
| minutes: | |||
| Azacitidine (25 mg/ml) | |||
| The Halyard Lavender Nitrile, | |||
| Powder-Free Exam Gloves Tested | |||
| for Use with Chemotherapy Drugs | |||
| and Fentanyl Citrate 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: | |||
| Azacitidine (25 mg/ml) | |||
| Bendamustine HCl (5 mg/ml) | |||
| Bleomycin Sulfate (15 mg/ml) | |||
| Bortezomib (1 mg/ml) | |||
| Busulfan (6 mg/ml) | |||
| Capecitabine (26 mg/ml) | |||
| Carboplatin (10 mg/ml) | |||
| Carlzomib (2 mg/ml) | |||
| Cetuximab (2 mg/ml) | |||
| Chloroquine (50 mg/ml) | |||
| Cisplatin (1 mg/ml) | |||
| Cladribine (1 mg/ml) | |||
| Cyclophosphamide (20 mg/ml) | |||
| Cyclosporin A (100 mg/ml) | |||
| Cytarabine (Cytosine) (100 mg/ml) | |||
| Cytovene (Ganciclovir) (10 mg/ml) | |||
| Dacarbazine (DTIC) (10 mg/ml) | |||
| Dactinomycin (0.5 mg/ml) | |||
| Daunorubicin HCl (5 mg/ml) | |||
| Decitabine (5 mg/ml) | |||
| Docetaxel (10 mg/ml) | |||
| Doxorubicin HCl (2 mg/ml) | |||
| Epirubicin HCl (Ellence) (2 mg/ml) | |||
| Etoposide (Toposar) (20 mg/ml) | |||
| Fludarabine (25 mg/ml) | |||
| 5-Fluorouracil (50 mg/ml) | |||
| Fulvestrant (50 mg/ml) | |||
| Gemcitabine (38 mg/ml) | |||
| Idarubicin (1 mg/ml) | |||
| Ifosfamide (50 mg/ml) | |||
| Irinotecan HCl (20 mg/ml) | |||
| Leuprolide Acetate Salt (5 mg/ml) | |||
| Mechlorethamine HCl (1 mg/ml) | |||
| Melphalan (5 mg/ml) | |||
| Methotrexate (25 mg/ml) | |||
| Mitomycin C (0.5 mg/ml) | |||
| Mitoxantrone (2 mg/ml) | |||
| Oxaliplatin (5 mg/ml) | Different | ||
| Page 4 of 11 |
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Image /page/7/Picture/0 description: The image contains a logo for Owens & Minor. The logo features the letters "OM" in a bold, stylized font, with the "O" consisting of several horizontal lines. To the right of the letters is the text "Owens & Minor" in a serif font. The logo is split into two colors, with the "OM" in a dark red and the "Owens & Minor" in gray.
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Image /page/8/Picture/0 description: The image contains the logo for Owens & Minor. The logo is split into two parts, with the left side containing the letters "OM" in a maroon color with horizontal lines running through them. The right side of the logo contains the words "Owens & Minor" in a gray color.
| Irinotecan HCl (20 mg/ml) | Paclitaxel (6 mg/ml) |
|---|---|
| Leuprolide Acetate Salt (5 mg/ml) | Pemetrexed (25 mg/ml) |
| Mechlorethamine HCl (1 mg/ml) | Raltitrexed (0.5 mg/ml) |
| Melphalan (5 mg/ml) | Retrovir (10 mg/ml) |
| Methotrexate (25 mg/ml) | Rituximab (10 mg/ml) |
| Mitomycin C (0.5 mg/ml) | Temsirolimus (25 mg/ml) |
| Mitoxantrone (2 mg/ml) | Topotecan HCl (1 mg/ml) |
| Oxaliptin (5 mg/ml) | Triclosan (2 mg/ml) |
| Paclitaxel (6 mg/ml) | Trisenox (1 mg/ml) |
| Pemetrexed (25 mg/ml) | Vinblastine Sulfate (1 mg/ml) |
| Raltitrexed (0.5 mg/ml) | Vincristine (1 mg/ml) |
| Retrovir (10 mg/ml) | Vinorelbine (10 mg/ml) |
| Rituximab (10 mg/ml) | Zoledronic Acid (0.8 mg/ml) |
| Temsirolimus (25 mg/ml) | The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. |
| Topotecan HCl (1 mg/ml) | The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 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 following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: | |
| Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. | |
| Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. | |
| The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: | |
| Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | |
| Warning: Not for Use With: | |
| Carmustine, Thiotepa |
9
Image /page/9/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 is the company name "Owens & Minor" in gray. The ampersand symbol is also in gray and is located between the two words.
| Technological
Characteristics | The glove is a colored, nitrile,
powder-free, textured fingertip,
ambidextrous, patient examination
glove. | The glove is a colored, nitrile,
powder-free, textured fingertip,
ambidextrous, patient examination
glove. | Same |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Color | Lavender | Lavender | Same |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Based on ISO 10993, Part 11
Biological Evaluation of Medical
Devices - Test for systemic toxicity,
the test article was considered non-
toxic. Meets the acceptance criteria. | Based ISO 10993 Biological
Evaluation of Medical devices -
Test for systemic toxicity, the test
article was considered non-toxic.
Meets the acceptance criteria. | Same |
| | Based on ISO 10993, Part 10-
Biological Evaluation of Medical
Devices – Test for irritation, the test
article was considered non-irritant.
Meets the acceptance criteria. | Based on ISO 10993, Part 10-
Biological Evaluation of Medical
Devices – Test for irritation, the
test article was considered non-
irritant. Meets the acceptance
criteria. | |
| | Based on ISO 10993, Part 10 -
Biological Evaluation of Medical
Devices – Test for skin sensitization,
the test article was considered a non-
sensitizer. Meets the acceptance
criteria. | Based on ISO 10993, Part 10 -
Biological Evaluation of Medical
Devices – Test for skin
sensitization, the test article was
considered non-sensitizer. Meets
the acceptance criteria. | |
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | Results | ||
| Subject Device | |||
| (K213937) | Results | ||
| Predicate Device | |||
| (K202622) | Remarks |
10
Image /page/10/Picture/0 description: The image contains the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, stylized font, with horizontal lines running through the letters. To the right of the letters is the text "Owens & Minor" in a serif font. The letters "OM" are in a dark red color, while the text "Owens & Minor" is in a gray color.
ASTM D6978-05
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
The following chemotherapy drugs The following chemotherapy drugs and concentration had NO and concentration had NO breakthrough breakthrough detected up to 240 detected up to 240 minutes: minutes: Azacitidine (25 mg/ml) Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Oxaliplatin (5 mg/ml) Pemetrexed (25 mg/ml) Paclitaxel (6 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Topotecan HCl (1 mg/ml)
Similar
11
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 letters. To the right of the letters, the words "Owens & Minor" are written in a light gray color. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
| | 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 following chemotherapy drugs
and concentration showed
breakthrough detected in less than
60 minutes:
Carmustine (3.3 mg/ml) No
breakthrough up to 0.3 minutes.
Thiotepa (10 mg/ml) No
breakthrough up to 30.9 minutes.
Warning: Not for Use With:
Carmustine, Thiotepa | 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 following chemotherapy drugs
and concentration showed
breakthrough detected in less than
60 minutes: Carmustine (3.3 mg/ml)
No breakthrough up to 0.3 minutes.
Thiotepa (10 mg/ml) No
breakthrough up to 30.9 minutes. | |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance Data for Hazardous Drugs (opioids) | | | |
| ASTM D6978-05
Standard Practice
for Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy
Drugs | The following hazardous drugs
(opioids) and concentration had NO
breakthrough detected up to 240
minutes:
No breakthrough was detected up
to 240 minutes for Fentanyl Citrate
Injection (100 mcg/2 ml) and
Simulated Gastric Acid
Fluid/Fentanyl Citrate
Injection Mix 50/50 Solution | The following hazardous drugs
(opioids) and concentration had NO
breakthrough detected up to 240
minutes:
Fentanyl Citrate Injection (100
mcg/2 ml) | Different |
| Performance Data | |||
|---|---|---|---|
| ASTM D5151-06 | |||
| Standard Test | |||
| Method for | |||
| Detection of Holes | |||
| in Medical Gloves | Testing of the subject device shows | ||
| it meets the 2.5% AQL requirement | |||
| in the standards for leakage. The | |||
| device meets the acceptance | |||
| criteria of the standard. | Testing of the subject device shows | ||
| it meets the 2.5% AQL requirement | |||
| in the standards for leakage. The | |||
| device meets the acceptance | |||
| criteria of the standard. | Same | ||
| ASTM D6124-06 | |||
| Standard Test | |||
| Method for Residual | |||
| Powder on Medical | |||
| Gloves | Residual powder on the subject | ||
| device is an average of 0.4 | |||
| mg/glove within the powder-free | |||
| limit of |