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510(k) K944763

CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER by Wells Lamont Corp. — Product Code LYU

K944763 is an FDA 510(k) premarket notification submitted by Wells Lamont Corp. for the device "CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Wells Lamont Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1995
Date Received
September 27, 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 Wells Lamont Corp.

  • K940274 — NYLON LINER GLOVES (May 12, 1994)
  • K925937 — WELLS LAMONT HANDAGES/MED WRAP DRESSINGS (August 9, 1993)
  • K922407 — WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS (June 15, 1993)

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