# K210656: ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/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: Jun 24, 2021 after 112 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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) 22.0 Thiotepa (10.0mg/ml) 24.2 Paclitaxel (6.0mg/ml) >240 Doxorubicin Hydrochloride (2.0mg/ml) >240 Methotrexate (25.0mg/ml) >240 Vincristine Sulfate (1.0mg/ml) >24 "WARNING: Do not use with Carmustine and Thiotepa"

Source page: https://510kreport.com/device/K210656
Methodology: https://510kreport.com/methodology