# K231938: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Mar 22, 2024 after 266 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K042805 (2004). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves, O&M Halyard, Inc. (2019) Summary page 10.

## Most influential descendants
- K243133: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (2025), 0 descendants of its own

## Indications for use
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 HCI (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 HCI (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCI (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCI (20 mg/mL) Doxorubicin HCI (2 mg/mL) Epirubicin HCI (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (1 00mg/mL.) 5-Fluorouracil (50 mg/mL) Gemcitabine HCI (38 mg/mL) Idarubicin HCI (1 mg/mL) Ifosfamide (IFEX) (50 mg/mL) Irinotecan HCI (20 mg/mL) Lenvatinib (20mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCI (1 mg/mL) Melphalan HCI (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCI (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 HCI (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 ThiocTEPA 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 HCI (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 HCI (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCI (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCI (20 mg/mL) Doxorubicin HCI (2 mg/mL) Epirubicin HCI (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Eribulin Mesylate (0.5 mg/mL) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCI (38 mg/mL) Idarubicin HCI (1 mg/mL) Ifosfamide (IFEX) (50 mg/mL) Irinotecan HCI (20 mg/mL.) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCI (1 mg/mL.) Melphalan HCI (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCI (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 HCI (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 HCI (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 HCI (Cytosine) (100 mg/mL) Dacarbazine (DTIC) (10 mg/mL) Dactinomycin (0.5 mg/mL) Daunorubicin HCI (5 mg/mL) Decitabine ( 5 mg/mL) Docetaxel HCI (20 mg/mL) Doxorubicin HCI (2 mg/mL) Epirubicin HCI (Ellence) (2 mg/mL) Etoposide (20 mg/mL) Floxuridine (100 mg/mL.) Fludarabine (25 mg/mL) 5-Fluorouracil (50 mg/mL) Gemcitabine HCI (38 mg/mL) Idarubicin HCI (1 mg/mL) Ifosfamide (IFEX) (50 mg/mL) Irinotecan HCI (20 mg/mL.) Lenvatinib (20 mg/mL) Leuprolide Acetate Salt (5 mg/mL) Mechlorethamine HCI (1 mg/mL.) Melphalan HCI (5 mg/mL) Methotrexate (25 mg/mL) Mitomycin C (0.5 mg/mL) Mitoxantrone HCI (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 HCI (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

Source page: https://510kreport.com/device/K231938
Methodology: https://510kreport.com/methodology