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510(k) K884295

SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE by Saybrex Intl., Inc. — Product Code LGM

K884295 is an FDA 510(k) premarket notification submitted by Saybrex Intl., Inc. for the device "SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE". The FDA issued a decision of Substantially Equivalent on November 8, 1988. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. Saybrex Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1988
Date Received
October 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

Other clearances by Saybrex Intl., Inc.

  • K884380 — BED SHEET, PILLOW CASE (November 8, 1988)

Other clearances for product code LGM

  • K231256 — Carecube Negative Pressure Isolation Chamber (January 3, 2024)
  • K163223 — ORCA (tm) - Operational Rescue Containment Apparatus (November 2, 2017)
  • K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000 (January 30, 2009)
  • K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (August 29, 2002)
  • K944133 — MTB 1043 TREATMENT BOOTH (September 7, 1995)
  • K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (February 18, 1992)
  • K896721 — MODEL 7-AT TREATMENT CHAMBER (January 22, 1990)
  • K874306 — INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE (March 22, 1988)
  • K864116 — ANAGO ISOLATION MASK (#80-950) (November 25, 1986)
  • K831062 — ISOLATION MASK I.C.S. (April 13, 1983)

FDA data resources