# K113707: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health-Medical Products and Services
- Decided: Apr 27, 2012 after 133 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013302 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102500: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating, Cardinal Health, Inc. (2010) 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
- K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (2016), 1 descendant of its own
- K161823: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (2017), 0 descendants of its own

## Recalls of this device
- Oct 31, 2018 · Class II · Z-0631-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0634-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0632-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0633-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0635-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0638-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0636-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 
- Oct 31, 2018 · Class II · Z-0637-2019: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves 

## Indications for use
These powder-free sterile light brown colored surgeon's gloves are 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: 1. Carmustine (BCNUJ) (3.3 mg/mi) — 0.2 2. Cisplastia, (1.0 mg/mi) — >240 3. Cyclophosphamide (20 mg/nil) — >240 4. Doxorubicin HCl (2.0 mg/mi) — >240 5. Etoposide (20 mg/mi) — >240 6. Fluorouracil (50.0 mg/nil) — >240 7. Methotrexate (25 mg/mi) — >240 8. Paclitaxel (6.0 mg/mi) — >240 9. Thiotepa (10.0 mg/mi) — 82.2 10. Vincristine Sulfate (1.0 mg/nil) — >240 Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNUL) (3.3 mg/mi) has a minimum breakthrough time of 0.20 minute.

Source page: https://510kreport.com/device/K113707
Methodology: https://510kreport.com/methodology