FDA 510(k) clearance · back to tracker

SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM

Terang Nusa Sdn Bhd cleared K140355 on 2014-11-06, decision: substantially equivalent

K-number

K140355

Sponsor

Terang Nusa Sdn Bhd

Device

SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM

Class

Class I

Decision

Substantially Equivalent

Decision date

2014-11-06

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K140355on accessdata.fda.gov →

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

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Source

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