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510(k) K943809

MONOGARD FACE SHIELD by White Knight Healthcare — Product Code LYU

K943809 is an FDA 510(k) premarket notification submitted by White Knight Healthcare for the device "MONOGARD FACE SHIELD". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. White Knight Healthcare has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
August 4, 1994
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 White Knight Healthcare

  • K001892 — WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (April 3, 2001)
  • K001997 — WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) (April 2, 2001)
  • K001893 — WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) (April 2, 2001)
  • K951984 — WHITE KNIGHT SURGEON'S VEST (July 25, 1995)
  • K942577 — SURGICAL TIP CLEANER (July 26, 1994)
  • K942576 — CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE (July 5, 1994)
  • K934969 — DUALGARD FACE SHIELD (March 28, 1994)

Other clearances for product code LYU

  • K011755 — STRYKER T4 HYTREL (R) TOGAS (June 22, 2001)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • 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)

FDA data resources