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510(k) K821044

PATIENT PREP KITS/TRAYS-STERILE by Phoenix Glove Co. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1982
Date Received
April 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Phoenix Glove Co.

  • K830660 — STERILE SURGICAL DRAPES (March 17, 1983)
  • K821666 — STERILE SURGICAL DRAPES (June 21, 1982)
  • K821043 — STERILE PATIENT EXAM. GLOVES (May 21, 1982)
  • K801846 — ELECTROCARDIOGRAPH ELECTRODE (September 9, 1980)
  • K781820 — GLOVES, VINYL EXAMINATION (December 7, 1978)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)