# K232079: Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Mar 28, 2024 after 259 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020019 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020019: Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim), Wrp Asia Pacific Sdn. Bhd. (2002) Summary page 6.

## Indications for use
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. NAT RUBBER LATEX SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL (GREEN): Chemotherapy Drug — Concentration — Average Breakthrough Detection Time (Minutes) Cisplatin (1.0 mg/ml) — > 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 Dacarbazine (10.0 mg/ml) — > 240 Doxorubicin Hydrochloride (2.0 mg/ml) — > 240 Etoposide (20.0 mg/ml) — > 240 Fluorouracil (50.0 mg/ml) — > 240 Ifosfamide (50.0 mg/ml) — > 240 Methotrexate (25.0 mg/ml) — > 240 Mitomycin C (0.5 mg/ml) — > 240 Mitoxantrone (2.0 mg/ml) — > 240 Paclitaxel (6.0 mg/ml) — > 240 Vincristine Sulfate (1.0 mg/ml) — > 240 *Thiotepa (10.0 mg/ml) — 14.7 *Carmustine (BCNU) (3.3 mg/ml) — 11.9 Opioid Drug — Breakthrough Detection Time in Minutes Fentanyl Citrate 100 mcg/2mL — No breakthrough up to 240 minutes *WA 9G: Testing showed an average breakthrough time of 11.9 minutes for Carmustine and an average breakthrough time of 14.7 minutes for Thiotepa. Do not use with Carmustine and Thiotepa. NATURAL RUBBER LATEX (STRIP&COAT)/(STRIP&PACK) SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL: Chemotherapy Drug — Concentration — Average Breakthrough Detection Time (Minutes) Cisplatin (1.0 mg/ml) — > 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240 Dacarbazine (10.0 mg/ml) — > 240 Doxorubicin Hydrochloride (2.0 mg/ml) — > 240 Etoposide (20.0 mg/ml) — > 240 Fluorouracil (50.0 mg/ml) — > 240 Ifosfamide (50.0 mg/ml) — > 240 Methotrexate (25.0 mg/ml) — > 240 Mitomycin C (0.5 mg/ml) — > 240 Mitoxantrone (2.0 mg/ml) — > 240 Paclitaxel (6.0 mg/ml) — > 240 Vincristine Sulfate (1.0 mg/ml) — > 240 *Thiotepa (10.0 mg/ml) — 13.8 *Carmustine (BCNU) (3.3 mg/ml) — 5.7 Opioid Drug — Breakthrough Detection Time in Minutes Fentanyl Citrate 100 mcg/2mL — No breakthrough up to 240 minutes *WARNING: Testing showed an average breakthrough time of 5.7 minutes for Carmustine and an average breakthrough time of 13.8 minutes for Thiotepa. Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K232079
Methodology: https://510kreport.com/methodology