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510(k) K896322

CN GAURD, STERILE LATEX SURGICAL GLOVES by C.N. Technocrats — Product Code FGO

K896322 is an FDA 510(k) premarket notification submitted by C.N. Technocrats for the device "CN GAURD, STERILE LATEX SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on July 12, 1990. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. C.N. Technocrats has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1990
Date Received
November 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by C.N. Technocrats

  • K896944 — CN CARE STERILE LATEX EXAMINATION GLOVES (January 10, 1990)
  • K893749 — CN GLOVES (September 26, 1989)
  • K892045 — LATEX EXAMINATION GLOVES, NON-STERILE (August 25, 1989)

Other clearances for product code FGO

  • K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (November 22, 2000)
  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources