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510(k) K992436

GOWN BACK, MODEL 13-403N; 13-404N; 13-405N by Techstyles — Product Code FYA

K992436 is an FDA 510(k) premarket notification submitted by Techstyles for the device "GOWN BACK, MODEL 13-403N; 13-404N; 13-405N". The FDA issued a decision of Substantially Equivalent on January 20, 2000. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Techstyles has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2000
Date Received
July 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Techstyles

  • K920045 — DURATECH HOSPITAL TOWEL (July 2, 1992)
  • K920153 — THERMUFF BAG (July 1, 1992)

Other clearances for product code FYA

  • K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (R (August 26, 2026)
  • K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (August 7, 2026)
  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (July 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (April 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)

FDA data resources