# 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

- Pathway: 510(k) (Traditional)
- Applicant: Careplus (M) Sdn Bhd
- Decided: Aug 3, 2021 after 146 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: 2 generations back to K983489 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103714: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera, Ansell Healthcare Products, LLC (2011) Summary page 5.

## Indications for use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: Test Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time in minutes Fluorouracil (50.0mg/ml) >240 Etoposide (20.0mg/ml) >240 Cyclophosphamide (20.0mg/ml) >240 Carmustine (3.3mg/ml) 14.1 Thiotepa (10.0mg/ml) 16.9 Paclitaxel (6.0mg/ml) , >240 Doxorubicin Hydrochloride (2.0mg/ml) >240 Methotrexate (25.0mg/ml) >240 Vincristine Sulfate (1.0mg/ml) >240 "WARNING: Do not use with Carmustine and Thiotepa" Powder Free Surgical gloves are sterile disposable devices intended to be worn by operatmg room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: Test Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time in minutes Fluorouracil (50.0mg/ml) >240 Etoposide (20.0mg/ml) >240 Cyclophosphamide (20.0mg/ml) >240 Carmustine (3.3mg/ml) 14.1 Thiotepa (10.0mg/ml) 16.9 Paclitaxel (6.0mg/ml) >240 Doxorubicin Hydrochloride (2.0mg/ml) >240 Methotrexate (25.0mg/ml) >240 Vincristine Sulfate (1.0mg/ml) >240 "WARNING: Do not use with Carmustine and Thiotepa"

Source page: https://510kreport.com/device/K210724
Methodology: https://510kreport.com/methodology