# K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Nov 8, 2019 after 184 days
- Product code: LZC (Medical Glove, Specialty)
- 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: 6 generations back to K042805 (2004). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, Halyard Health (2018) Summary page 7.

## Most influential descendants
- 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 (2024), 1 descendant of its own
- 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
- K220541: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves (2022), 0 descendants of its own

## Indications for use
The Halyard Sterling Nitrile Powder-Free Exam Gloves 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: Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes, Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves 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: Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes Paraplatin (10 mg/ml), No breakthrough up to 240 minutes Bendamustine (5 mg/ml), No breakthrough up to 240 minutes Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes Etoposide (20 mg/ml), No breakthrough up to 240 minutes Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes Fludarabine (25 mg/ml), No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes Busulfan (6 mg/ml),No breakthrough up to 240 minutes Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml), No breakthrough up to 240 minutes Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes Rituximab (10 mg/ml), No breakthrough up to 240 minutes Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes Idarubicin (1 mg/ml), No breakthrough up to 240 minutes Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes Cisplatin (1 mg/ml), No breakthrough up to 240 minutes Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes Irinotecan (20 mg/ml), No breakthrough up to 240 minutes Triclosan (2 mg/ml), No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes Trisonex (1 mg/ml), No breakthrough up to 240 minutes Cytovene (10 mg/ml), No breakthrough up to 240 minutes Melphalan (5 mg/ml), No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes Methotrexate (25 mg/ml), No breakthrough up to 240 minutes, Vinblastine (1 mg/ml), No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes Decitabine (5 mg/ml), No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes Docetaxel (10 mg/ml), No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes

Source page: https://510kreport.com/device/K191230
Methodology: https://510kreport.com/methodology