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510(k) K965237

NURSES BOUFFANT CAP by Copioumed Intl., Inc. — Product Code LYU

K965237 is an FDA 510(k) premarket notification submitted by Copioumed Intl., Inc. for the device "NURSES BOUFFANT CAP". The FDA issued a decision of Substantially Equivalent on August 27, 1997. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Copioumed Intl., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1997
Date Received
December 31, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Copioumed Intl., Inc.

  • K030927 — POWDERED VINYL EXAM GLOVES, WHITE (April 17, 2003)
  • K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (July 2, 2002)
  • K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (June 10, 2002)
  • K972624 — POLY (VINYL) EXAM GLOVE, POWDER-FREE (November 6, 1997)
  • K971316 — POLY (VINYL) EXAM GLOVE, POWDERED (August 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
  • K960999 — ISOLATION GOWN (December 30, 1996)

Other clearances for product code LYU

  • K011755 — STRYKER T4 HYTREL (R) TOGAS (June 22, 2001)
  • K970988 — FAR-EAST BOUFFANT CAPS (July 10, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)

FDA data resources