FDA 510(k) clearance · back to tracker

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Encompass Industries Sdn. Bhd. cleared K250342 on 2025-07-08, decision: substantially equivalent

K-number

K250342

Sponsor

Encompass Industries Sdn. Bhd.

Device

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-07-08

Product code

LZA

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K250342on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K250342 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.