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510(k) K830660

STERILE SURGICAL DRAPES by Phoenix Glove Co. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
March 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Phoenix Glove Co.

  • K821044 — PATIENT PREP KITS/TRAYS-STERILE (June 23, 1982)
  • 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 KKX

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  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)