SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.— 510(k) K904878

Name: FDA 510(k) clearance K904878
Creator: U.S. Food and Drug Administration
Published: 1991-03-07

Substantially Equivalent

Hpi, Inc.

FDA 510(k) clearance K904878 for SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER., Substantially Equivalent on 1991-03-07. Applicant: Hpi, Inc.. Device class: 1.

Clearance details

Applicant: Hpi, Inc.
Product code: Code IWP
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1990-10-30
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton Centre, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWP

view all

K920538 — PROTECTIVE RADIOGRAFIC GLOVE1992-05-29
K905086 — HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES1990-12-03
K900972 — RADIATION PROTECTION GLOVES1990-05-01
K844683 — IMAGEN CHLAMYDIA TEST1985-02-06

More clearances from Hpi, Inc.

view all

K922116 — POWDER FREE NITRILE GLOVE1993-02-08
K915086 — HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES1992-06-17
K910383 — HPI SENSI-SHIELD GLOVE KIT1991-03-20
K901608 — HPI POWDER FREE NON-STERILE EXAMINATION GLOVES1990-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.