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Isolation Gowns

by Pfb Inter-Apparel Corp. 510(k)

Active United States

510(k) K922442

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922442 Date12 Oct 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FYC
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Pfb Inter-Apparel Corp.

  • Drapes

    Class II