# K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Jun 8, 2011 after 128 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011721 (2001). 3 ancestors in all.
6 later devices descend from it; 3 cite 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)
- K093300: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves, Cardinal Health, Inc. (2009) Summary page 1.
- K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim, Allegiance Healthcare Corp. (2001) Summary page 1.

## Most influential descendants
- K152428: SensiCare PI Surgical Gloves (2016), 2 descendants of its own
- K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series (2015), 1 descendant of its own
- K193573: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (2020), 0 descendants of its own
- K171898: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (2017), 0 descendants of its own
- K170198: Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) (2017), 0 descendants of its own

## Recalls of this device
- Mar 15, 2022 · Class II · Z-0902-2022: Product was distributed without being sterilized.

## Indications for use
This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy drug and concentration — Minimum breakthrough detection time in minutes, 0.01 μg/cm²/minute: Blenoxane (15 mg/ml) — >240 Busulfan (6 mg/ml) — >240 Carmustine (BCNU) (3.3 mg/ml) — 0.37 Cisplatin (1.0 mg/ml) — >240 Cytarabine (100 mg/ml) — >240 Cyclophosphamide (20 mg/ml) — >240 Dacarbazine (10 mg/ml) — >240 Doxorubicin HCl (2.0 mg/ml) — >240 Ellence (25 mg/ml) — >240 Etoposide (Toposar) (20 mg/ml) — >240 Fludarabine (25 mg/ml) — >240 Fluorouracil (50 mg/ml) — >240 Idarubicin (1 mg/ml) — >240 Ifosfamide (50 mg/ml) — >240 Mechlorethamine HCl (1 mg/ml) — >240 Melphalan (5 mg/ml) — >240 Methotrexate (25 mg/ml) — >240 Mitoxantrone (2 mg/ml) — >240 Mitomycin C (0.5 mg/ml) — >240 Paclitaxel (Taxol) (6.0 mg/ml) — >240 Paraplatin (10 mg/ml) — >240 Rituximab (10 mg/ml) — >240 Thiotepa (10 mg/ml) — 0.44 Trisenox (0.1 mg/ml) — >240 Vincristine sulfate (1 mg/ml) — >240 Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.37 minute. Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.

Source page: https://510kreport.com/device/K110272
Methodology: https://510kreport.com/methodology