# K103714: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Jul 7, 2011 after 198 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 K983489 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983489: Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or LE), Ansell Perry (1998) 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
- K210724: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (2021), 0 descendants of its own

## Indications for use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05) Vincristine Sulfate (1.0mg/mL) >240 Carmustine (BiCNU) (3.3mg/mL) 1.5 Cyclophosphamide (Cytoxan)(20.0mg/mL) >240 Doxorubicin Hydrochloride (2.0mg/mL) >240 5-Fluorouracil (50.0mg/mL) >240 Methotrexate (25.0mg/mL) >240 Etoposide (Toposar) (20.0mg/mL) >240 Paclitaxel (Taxol)(6.0mg/mL) >240 ThioTEPA (10.0mg/mL) 15.26 Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.

Source page: https://510kreport.com/device/K103714
Methodology: https://510kreport.com/methodology