CUT RESISTANT GLOVE LINER— 510(k) K902633

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K902633 for CUT RESISTANT GLOVE LINER, Substantially Equivalent on 1990-07-27. Applicant: Biomet, Inc.. Device class: 1.

Clearance details

Applicant: Biomet, Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1990-06-14
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYU

K011755 — STRYKER T4 HYTREL (R) TOGAS2001-06-22
K965237 — NURSES BOUFFANT CAP1997-08-27
K970988 — FAR-EAST BOUFFANT CAPS1997-07-10
K964364 — DISPOSABLE APRON1997-02-25
K961791 — DEPUY DISPOSABLE FILTER/HOOD1996-08-09

More clearances from Biomet, Inc.

K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Recalls naming K902633

K-number listed on FDA's recall record

Z-0609-2018 — BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131Class II·Terminated·Zimmer Biomet, Inc.·20170911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902633.

Data sourced from openFDA. This site is unofficial and independent of the FDA.