510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920538Substantially Equivalent

Protective Radiografic Glove

Burkhart Roentgen Intl., Inc., Pinellas Park FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920538 is the FDA 510(k) clearance record for PROTECTIVE RADIOGRAFIC GLOVE, a class I device, cleared for Burkhart Roentgen Intl., Inc. on under FDA product code IWP (Radiographic Protective Glove). FDA's definition for product code IWP reads: "A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating...". FDA records list 3 510(k) clearances for Burkhart Roentgen Intl., Inc., from to . As of , FDA records show no recalls naming K920538.

Clearance record

Decision date
Received
(114 days to decision)
Product code
IWP Radiographic Protective Glove
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Burkhart Roentgen Intl., Inc. 6571 43rd St., N., Pinellas Park FL
510(k) summary
Statement
Third party review
No

Clearances, product code IWP

Trailing 12 months

FDA records hold no clearances under product code IWP in the trailing twelve months.

FDA records show no clearances under product code IWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260