(243 days)
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
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.
The document describes the acceptance criteria and performance of the "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".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Meets requirements | |
| Length | 295 – 325 mm | Within limits of the standard | |
| Palm Width Size | X-Small: 60 – 80 mm; Small: 70 – 90 mm; Med: 85 – 105 mm; Large: 100 – 120 mm; X-Large: 110-130 mm | Within limits of the standard | |
| Finger thickness | 0.10-0.19 mm | Within limits of the standard | |
| Palm thickness | 0.10-0.16 mm | Within limits of the standard | |
| Cuff thickness | 0.10-0.13 mm | Within limits of the standard | |
| Physical Properties | ASTM D 6319 | AQL 4.0; Before aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%; After aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements (met the requirements for tensile strength before and after aging; also met the requirement for elongation before and after aging) |
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | AQL 2.5%, No leakage | Meets requirements (Testing shows it meets the 2.5% AQL requirement in the standards for leakage) |
| Powder Free | ASTM D 6124, ASTM D 6319 | < 2 mg / glove | Meets requirements (Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit) |
| Test for Irritation | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Under the conditions of the study, the device is not an irritant (nonirritating in a 204 subject study) |
| Test for Systemic Toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity (considered non-toxic) |
| Test for Skin Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditions of the study, the device is not a sensitizer (showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects in a 204 subject study) |
| Resistance to Permeation by Chemotherapy Drugs and Hazardous Drugs (opioids) | ASTM D6978-05 | No breakthrough for up to 240 minutes for the listed chemotherapy drugs and hazardous drugs. For Carmustine and Thiotepa, breakthrough detected in less than 60 minutes. | Chemotherapy Drugs: NO breakthrough detected up to 240 minutes for Azacitidine, Bendamustine HCl, Bleomycin Sulfate, Bortezomib, Busulfan, Capecitabine, Carboplatin, Carlzomib, Cetuximab, Chloroquine, Cisplatin, Cladribine, Cyclophosphamide, Cyclosporin A, Cytarabine (Cytosine), Cytovene (Ganciclovir), Dacarbazine (DTIC), Dactinomycin, Daunorubicin HCl, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl (Ellence), Etoposide (Toposar), Fludarabine, 5-Fluorouracil, Fulvestrant, Gemcitabine, Idarubicin, Ifosfamide, Irinotecan HCl, Leuprolide Acetate Salt, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone, Oxaliplatin, Paclitaxel, Pemetrexed, Raltitrexed, Retrovir, Rituximab, Temsirolimus, Topotecan HCl, Triclosan, Trisenox, Vinblastine Sulfate, Vincristine, Vinorelbine, Zoledronic Acid.Breakthrough detected in less than 60 minutes: Carmustine (0.3 minutes), Thiotepa (30.9 minutes).Hazardous Drugs (opioids): NO breakthrough 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Clinical Test (Modified DRAIZE-95 Test for Low Dermatitis Potential):
- Sample Size: 204 subjects.
- Data Provenance: Not explicitly stated, but implies a prospective study involving normal healthy human volunteers due to the nature of the Draize test. Country of origin is not mentioned.
-
Non-Clinical Tests (Mechanical Properties, Permeation, Biocompatibility): The document does not specify exact sample sizes for each non-clinical test (e.g., number of gloves tested for permeation, pinholes, or physical properties). These are typically laboratory-based tests following standard protocols. Data provenance related to country of origin is not provided, but the tests refer to international standards (ASTM, ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes a medical device (exam gloves) for which "ground truth" as defined for AI/diagnostic studies (e.g., expert consensus on image interpretation) is not relevant. The performance is assessed against established physical, chemical, and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers/experts to establish a definitive diagnosis or assessment, which is not the case here.
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
This is not applicable. The device is an exam glove and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an exam glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests conducted, the "ground truth" is defined by:
- Established industry standards and regulatory limits (e.g., ASTM D6319 for physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder, ASTM D6978-05 for drug permeation, ISO 10993 for biocompatibility).
- Observed physical and chemical properties of the gloves (e.g., measured dimensions, tensile strength, elongation, residual powder, breakthrough time for drugs).
- Clinical observation of human subjects for irritation and sensitization (for the dermatitis potential test).
8. The sample size for the training set
This is not applicable. The document describes the testing of a manufactured physical device (gloves), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is 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 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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
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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)
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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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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 DriveAlpharetta, GA 30005 |
| Primary Contact forthis 510(k) Submission | Angela L. Bunn, RACTel: 470-364-7147Email: angela.bunn@owens-minor.com |
| Marketed Device Trade Name | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Device Submission Trade nameand Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination GloveLZC Class I, 21 CFR §880.6250 Patient Examination Glove, SpecialtyOQD Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove |
| Predicate Device | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Testedfor Use with Chemotherapy Drugs (K202622) |
| Subject Device Description | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution aredisposable, lavender colored, chlorinated, nitrile, powder-free, texturedfingertip, ambidextrous, non-sterile patient examination gloves. Thesegloves will be available in sizes Extra Small, Small, Medium, Large and ExtraLarge. |
| Indications for Use | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposabledevices intended for medical purposes that is worn on the examiner's hand toprevent contamination between patient and examiner. These gloves weretested for use with the following chemotherapy drugs, Fentanyl Citrate andSimulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution asper ASTM -D6978-05 :The following chemotherapy drugs and concentration had NO breakthroughdetected 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 | |
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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.
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Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters 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, LowDermatitis Potential, Powder-FreeExam Gloves Tested for Use withChemotherapy Drugs andFentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl CitrateInjection Mix 50/50 Solution | Halyard Lavender, Nitrile, Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs andFentanyl Citrate | Similar |
| IntendedUse/Indications forUse | Halyard Lavender Nitrile, LowDermatitis Potential, Powder-FreeExam Gloves Tested for Use withChemotherapy Drugs, FentanylCitrate and Simulated Gastric AcidFluid/Fentanyl Citrate Injection Mix50/50 Solution are disposable devicesintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner. These gloveswere tested for use with thefollowing chemotherapy drugs,Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl CitrateInjection Mix 50/50 Solution as perASTM -D6978-05 :The following chemotherapy drugsand concentration had NObreakthrough detected up to 240minutes:Azacitidine (25 mg/ml) | The Halyard Lavender Nitrile,Powder-Free Exam Gloves Testedfor Use with Chemotherapy Drugsand Fentanyl Citrate aredisposable devices intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner.The following chemotherapy drugsand concentration had NObreakthrough detected up to 240minutes: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) | DifferentPage 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 |
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Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a 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.
| TechnologicalCharacteristics | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | The glove is a colored, nitrile,powder-free, textured fingertip,ambidextrous, patient examinationglove. | 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 11Biological Evaluation of MedicalDevices - Test for systemic toxicity,the test article was considered non-toxic. Meets the acceptance criteria. | Based ISO 10993 BiologicalEvaluation of Medical devices -Test for systemic toxicity, the testarticle was considered non-toxic.Meets the acceptance criteria. | Same |
| Based on ISO 10993, Part 10-Biological Evaluation of MedicalDevices – Test for irritation, the testarticle was considered non-irritant.Meets the acceptance criteria. | Based on ISO 10993, Part 10-Biological Evaluation of MedicalDevices – Test for irritation, thetest article was considered non-irritant. Meets the acceptancecriteria. | ||
| Based on ISO 10993, Part 10 -Biological Evaluation of MedicalDevices – Test for skin sensitization,the test article was considered a non-sensitizer. Meets the acceptancecriteria. | Based on ISO 10993, Part 10 -Biological Evaluation of MedicalDevices – Test for skinsensitization, the test article wasconsidered non-sensitizer. Meetsthe acceptance criteria. |
| Performance Data for Chemotherapy Drugs | |||
|---|---|---|---|
| Standard | ResultsSubject Device(K213937) | ResultsPredicate Device(K202622) | Remarks |
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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
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Image /page/11/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the 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 drugsand concentration showedbreakthrough detected in less than60 minutes:Carmustine (3.3 mg/ml) Nobreakthrough up to 0.3 minutes.Thiotepa (10 mg/ml) Nobreakthrough 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 drugsand concentration showedbreakthrough detected in less than60 minutes: Carmustine (3.3 mg/ml)No breakthrough up to 0.3 minutes.Thiotepa (10 mg/ml) Nobreakthrough up to 30.9 minutes. | ||
|---|---|---|---|
| Performance Data for Hazardous Drugs (opioids) | |||
| ASTM D6978-05Standard Practicefor Assessment ofResistance ofMedical Gloves toPermeation byChemotherapyDrugs | The following hazardous drugs(opioids) and concentration had NObreakthrough detected up to 240minutes:No breakthrough was detected upto 240 minutes for Fentanyl CitrateInjection (100 mcg/2 ml) andSimulated Gastric AcidFluid/Fentanyl CitrateInjection Mix 50/50 Solution | The following hazardous drugs(opioids) and concentration had NObreakthrough detected up to 240minutes:Fentanyl Citrate Injection (100mcg/2 ml) | Different |
| Performance Data | |||
|---|---|---|---|
| ASTM D5151-06Standard TestMethod forDetection of Holesin Medical Gloves | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptancecriteria of the standard. | Testing of the subject device showsit meets the 2.5% AQL requirementin the standards for leakage. Thedevice meets the acceptancecriteria of the standard. | Same |
| ASTM D6124-06Standard TestMethod for ResidualPowder on MedicalGloves | Residual powder on the subjectdevice is an average of 0.4mg/glove within the powder-freelimit of < 2 mg maximum powderper glove and meets the | Residual powder on the subjectdevice is an average of 0.4 mg/glovewithin the powder-free limit of < 2mg maximum powder per glove andmeets the acceptance criteria for | Same |
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Image /page/12/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon color on the left side. To the right of the letters is the company name "Owens & Minor" in a gray color.
| acceptance criteria for powder- | powder- free. | ||
|---|---|---|---|
| ASTM D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplications | free.The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject devicemet the requirements for tensilestrength before and after aging.The subject device also met therequirement for elongation beforeand after aging. | The physical dimensions of thesubject device are within the limitsof the standard and the physicalproperties of the subject device metthe requirements for tensilestrength before and after aging. Thesubject device also met therequirement for elongation beforeand after aging. | Same |
| Clinical test | A 204 subject study was completedto evaluate whether the level ofresidual chemical additives in thesubject device induced Type IVallergic contact sensitization byrepetitive applications to the skin ofnormal healthy human volunteersusing the Jordan-King modificationof the Draize test as recommendedby the FDA.Under the conditions of the study,the subject device was nonirritatingand showed no clinicalevidence of residual chemicaladditives that may induce Type IVallergy in human subject | Not previously tested. | Different |
SUMMARY OF NON-CLINICAL TESTING
| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meetsrequirements | ||
| Length | 295 – 325 mm | |||
| Palm Width Size | X-Small: 60 – 80 mm | |||
| Small: 70 – 90 mm | ||||
| Med: 85 – 105 mm | ||||
| Large: 100 – 120 mm | ||||
| X-Large: 110-130 mm | ||||
| Finger thickness | 0.10-0.19 mm | |||
| Palm thickness | 0.10-0.16 mm | |||
| Cuff thickness | 0.10-0.13 mm | |||
| Physical Properties | ASTM D 6319 | AQL 4.0BeforeTensile Strength: ≥14 MPa | Meetsrequirements | |
| Ultimate elongation:≥500% | ||||
| AfterTensile Strength: ≥14 MPaUltimate elongation:≥400% | ||||
| Freedom from | ASTM D 6319 | AQL 2.5% | Meets | |
| Pinholes | ASTM D 5151 | No leakage | requirements | |
| Powder Free | ASTM D 6124ASTM D 6319 | $<$ 2 mg / glove | Meetsrequirements | |
| Test for irritation | ISO 10993, Part 10 | Primary IrritationIndex≤ 2.0 | Under theconditions ofthestudy the device isnot an irritant | |
| Test for systemictoxicity | ISO 10993, Part 11 | No animals treatedwith testextracts exhibitgreaterreaction than controlanimals | No evidence ofsystemic toxicity | |
| Test for skinsensitization | ISO 10993, Part 10 | Grade < 1 | Under theconditionsof the study thedevice is not asensitizer | |
| Standard PracticeforAssessment ofResistance ofMedicalGloves toPermeationby ChemotherapyDrugs | ASTM D6978-05 | No breakthroughfor up to 240 minutes | No signs ofbreakthrough for thesubject device after 4hours for 50chemotherapy drugs,FentanylCitrate Injection (100mcg/2ml) andSimulated GastricAcidFluid/FentanylCitrate InjectionMix 50/50Solution.The followingchemotherapydrugs andconcentration |
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Image /page/13/Picture/0 description: The image contains the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray sans-serif font. The ampersand symbol (&) is placed between the two words.
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Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of two parts: a maroon-colored symbol on the left and the company name in gray on the right. The symbol is a stylized "OM" with horizontal lines running through it. The company name is "Owens & Minor" with the "&" symbol in between.
| breakthroughdetected in lessthan 60 minutes:Carmustine (3.3mg/ml) Nobreakthrough upto 0.3 minutes.Thiotepa (10mg/ml) Nobreakthrough upto 30.9 minutes |
|---|
SUMMARY OF CLINICAL TESTING
| Test | Description | Results |
|---|---|---|
| Modified DRAIZE-95 Test toEvaluate Low DermatitisPotential of Medical Gloves | A 204 subject study was completed to evaluatewhether the level of residual chemical additives inthe subject device (K213929) induced Type IVallergic contact sensitization by repetitiveapplications to the skin of normal healthy humanvolunteers using the Jordan-King modification ofthe Draize test as recommended by the FDA. | Under the conditions ofthe study, the subjectdevice was nonirritatingand showed no clinicalevidence of residualchemical additives thatmay induce Type IV allergyin human subjects. |
| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that thesubject device (Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free ExamGloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate and SimulatedGastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution) are as safe, as effective,and performs as well as or better than the legally marketed devices cleared underK202622. |
|---|---|
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.