# K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

- Pathway: 510(k) (Traditional)
- Applicant: Careplus (M) Sdn Bhd
- Decided: May 27, 2021 after 248 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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K232444: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (2023), 0 descendants of its own

## 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) 13.2 Thiotepa (10.0mg/ml) 12.0 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 Carmustine and Thiotepa"

Source page: https://510kreport.com/device/K202765
Methodology: https://510kreport.com/methodology