510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K905527Substantially Equivalent

Needlestick Protective Glove

Medev Corp., Hampton VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905527 is the FDA 510(k) clearance record for NEEDLESTICK PROTECTIVE GLOVE, a class I device, cleared for Medev Corp. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition...". FDA records list one 510(k) clearance for Medev Corp. As of , FDA records show no recalls naming K905527.

Clearance record

Decision date
Received
(102 days to decision)
Product code
LZC Medical Glove, Specialty
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Medev Corp. Post Office Box 7155, Hampton VA
Third party review
No

Clearances, product code LZC

Trailing 12 months
1 clearance under product code LZC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260