(266 days)
The Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (1 00mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/mL), breakthrough detected at 22.9 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/mL), breakthrough detected at 37.1 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Eribulin Mesylate (0.5 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Raltitrexed (0.5 mg/mL) Ritux1mab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Tamoxifen (2 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 20 minutes: Carmustine (BCNU) (3.3 mg/ml), breakthrough detected at 14.8 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes: Cyclosporin A (100 mg/mL) Cytovene (Ganciclovir) (10 mg/mL) Retrovir (Zidovudine) (10 mg/mL)
The Halyard STERLING NITRILE-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs. Fentanyl Citrate and Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (Vidaza) (25 mg/mL) Bendamustine HCl (5 mg/mL) Bleomycin Sulfate (Blenoxane) (15 mg/mL) Bortezomib (Velcade) (1 mg/mL) Busulfan (6 mg/mL) Capecitabine (26 mg/mL) Carboplatin ( 10 mg/mL) Carfilzomib (2 mg/mL) Cetuximab (Erbitux) (2 mg/mL) Cisplatin (1 mg/mL) Cladribine (1 mg/mL) Cyclophosphamide (20 mg/mL) Cytarabine HCl (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCl (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCl (20 mg/mL) Doxorubicin HCl (2 mg/mL) Epirubicin HCl (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (100 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCl (38 mg/mL) Idarubicin HCl (1 mg/mL) lfosfamide (IFEX) (50 mg/mL) Irinotecan HCl (20 mg/mL) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCl (1 mg/mL) Melphalan HCl (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCl (2 mg/mL) Nelarabine (5 mg/mL) Oxaliplatin (5 mg/mL) Paclitaxel (Taxol) (6 mg/mL (6,000 ppm) Pemetrexed (25 mg/mL) Ralt1trexed (0.5 mg/mL) Rituximab ( 10 mg/mL) Sorafenib Tosylate (200 mg/mL) Streptozocin (100 mg/mL) Tamoxifen (2 mg/mL) Teniposide (10 mg/mL) Topotecan HCl (1 mg/mL) Trisenox (Arsenic Trioxide) (1 mg/mL) Vinblastine Sulfate (1 mg/mL) Vincristine Sulfate (Oncovin) (1 mg/mL) Vinorelbine (10 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 30 minutes: Carmustine (3.3 mg/ml), breakthrough detected at 25.2 minutes
The following chemotherapy drugs and concentration showed breakthrough detected in less than 40 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 35.5 minutes
Warning: Do not use with Carmustine or ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The subject devices are disposable, grey-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for Halyard STERLING Nitrile Powder-Free Exam Gloves and related products. It outlines the regulatory classification, intended use, and a comparison of technological characteristics and performance data against predicate and reference devices to demonstrate substantial equivalence.
Based on the content, this document describes physical and chemical testing of medical gloves, not an AI/ML-enabled medical device. Therefore, many of the requested
details, such as sample size for test/training sets, data provenance, expert
ground truth establishment, adjudication methods, MRMC studies, standalone
algorithm performance, and specific effect sizes for human readers with/without
AI assistance, are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for these physical products based on the provided tables.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these medical gloves are based on various ASTM and ISO standards for physical properties, residual powder, and biological safety. The "Reported device performance" directly aligns with the "Subject Devices" column in the "PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE" table.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance (Subject Devices) |
|---|---|
| ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: | |
| • Meets 2.5% AQL (Acceptable Quality Level) requirement for leakage. | Halyard STERLING Nitrile Powder-Free Exam Gloves, Halyard STERLING SG SENSI-GUARD Powder-Free Nitrile Exam Gloves, Halyard STERLING NITRILE-XTRA Powder-Free Exam Gloves: |
| • Meets the 2.5% AQL requirement for leakage. | |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: | |
| • Residual powder |
§ 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.