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510(k) K920538

PROTECTIVE RADIOGRAFIC GLOVE by Burkhart Roentgen Intl., Inc. — Product Code IWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiographic Protective Glove
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

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 barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

Other clearances by Burkhart Roentgen Intl., Inc.

  • K920539 — ORWO X-RAY FILM (June 30, 1992)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)

Other clearances for product code IWP

  • K904878 — SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (March 7, 1991)
  • K905086 — HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (December 3, 1990)
  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K844683 — IMAGEN CHLAMYDIA TEST (February 6, 1985)