510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950995Substantially Equivalent

Sensicare Synthetic, Surgical Glove Liner

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lake NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950995 is the FDA 510(k) clearance record for SENSICARE SYNTHETIC, SURGICAL GLOVE LINER, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code LYN (Apparatus, Visual Reinforcement Audiometric). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K950995.

Clearance record

Decision date
Received
(117 days to decision)
Product code
LYN Apparatus, Visual Reinforcement Audiometric
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic One Becton Dr., Franklin Lake NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LYN

Trailing 12 months

FDA records hold no clearances under product code LYN in the trailing twelve months.

FDA records show no clearances under product code LYN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260