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510(k) K922407

WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS by Wells Lamont Corp. — Product Code LYU

K922407 is an FDA 510(k) premarket notification submitted by Wells Lamont Corp. for the device "WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS". The FDA issued a decision of Substantially Equivalent on June 15, 1993. 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
June 15, 1993
Date Received
May 21, 1992
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.

  • K944763 — CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEP (April 10, 1995)
  • K940274 — NYLON LINER GLOVES (May 12, 1994)
  • K925937 — WELLS LAMONT HANDAGES/MED WRAP DRESSINGS (August 9, 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